AzTrials
AzTrials

COPDPhase 4NCT01985334

Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

A Phase 4 study testing Glycopyrronium, SABA and LABA in people with COPD, run by Novartis Pharmaceuticals at 542 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. Read more about this study

Who is it for?
Ages 40 to 95 years
Conditions the study is for
COPD
What is being tested?
Glycopyrronium, SABA and LABA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,389 participants
Where
542 sitesin 23 countries
Study dates
14 Feb 2014to 29 Apr 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female adults aged ≥ 40 years
  • Patients with moderate COPD according to the GOLD criteria 2013
  • Current or ex-smokers who have a smoking history of at least 10 pack years
  • Patients with airflow limitation indicated by a postbronchodilator FEV1 ≥50% and <80% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at Visit 2. Post- bronchodilator refers to within 10-15 min of inhalation of 400 μg (4x100 μg) of salbutamol
  • Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments: *Any SABA monotherapy (such as, but not limited to, salbutamol) *Any SAMA monotherapy (such as, but not limited to, ipratropium) *Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium) *Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol) *Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237) *Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide).
  • Patients with an mMRC score ≥1 at Visit 1.

Who cannot join

  • Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof: Anti-cholinergic agents, Long- and short-acting 2-adrenergic agonists, Sympathomimetic amines, Lactose or any of the other excipients of the trial medication.
  • Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis.
  • Patients with active/ clinical history of asthma.If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision.
  • Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 result at Visit 2 (see Appendix 5 for details).
  • A documented history of >1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months.
Show all 16Show fewer
  • Patients who have NOT had a COPD exacerbation in the previous 12 months and develop a COPD exacerbation between screening (Visit 1) and (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. (Patients suffering an exacerbation between Visit 1 and Visit 2 can only be re-screened in case it is the first one in the previous 12 months. In case this COPD exacerbation has led to an alteration of the patient COPD treatment, before this patient can be re-screened 3 months of stable COPD treatment will be required as described in Inclusion Criterion 6).
  • Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): *Unstable ischemic heart disease, left ventricular failure (NYHA Class III \& IV), history of myocardial infarction,arrhythmia (excluding chronic stable atrial fibrillation). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study.*Uncontrolled hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state. *Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
  • History of resting QTc (Fridericia preferred, but Bazett acceptable) >450 msec (male) or >460 msec (female) within five years before Visit 1.
  • Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trialPatients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day wash-out period.
  • Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD related medications must undergo the required wash-out period prior to Visit 2.
  • Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
  • Patients with a body mass index (BMI) of more than 40 kg/m2.
  • Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Trial locations and contacts

542 sites in 23 countries.

542 sites in 23 countries

Germany191 sites

  • Novartis Investigative Site

    Annaberg-Buchholz, 09456

  • Novartis Investigative Site

    Auerbach, 08209

  • Novartis Investigative Site

    Augsburg, 86150

  • Novartis Investigative Site

    Bad Neustadt an der Saale, 97616

  • Novartis Investigative Site

    Bad Salzuflen, 32105

  • Novartis Investigative Site

    Bad Wörishofen, 86825

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Bensheim, 64625

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Berlin, 10119

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 10625

  • Novartis Investigative Site

    Berlin, 10629

  • Novartis Investigative Site

    Berlin, 10717

  • Novartis Investigative Site

    Berlin, 10787

  • Novartis Investigative Site

    Berlin, 12099

  • Novartis Investigative Site

    Berlin, 12157

  • Novartis Investigative Site

    Berlin, 12159

  • Novartis Investigative Site

    Berlin, 12165

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 12627

  • Novartis Investigative Site

    Berlin, 12687

  • Novartis Investigative Site

    Berlin, 13057

  • Novartis Investigative Site

    Berlin, 13086

  • Novartis Investigative Site

    Berlin, 13156

  • Novartis Investigative Site

    Berlin, 13187

  • Novartis Investigative Site

    Berlin, 13507

  • Novartis Investigative Site

    Berlin, 14059

  • Novartis Investigative Site

    Berlin, D-12165

  • Novartis Investigative Site

    Bielefeld, 33617

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Bonn, 53123

  • Novartis Investigative Site

    Bottrop, 46240

  • Novartis Investigative Site

    Bruchsal, 76646

  • Novartis Investigative Site

    Burgwedel, 30938

  • Novartis Investigative Site

    Cologne, 50668

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Cologne, 51069

  • Novartis Investigative Site

    Cologne, 51605

  • Novartis Investigative Site

    Cottbus, Saxony, 03050

  • Novartis Investigative Site

    Daaden, 57567

  • Novartis Investigative Site

    Dachau, 85221

  • Novartis Investigative Site

    Deggendorf, 94469

  • Novartis Investigative Site

    Deggingen, 73328

  • Novartis Investigative Site

    Delitzsch, 04509

  • Novartis Investigative Site

    Dortmund, 44263

  • Novartis Investigative Site

    Dresden, 01069

  • Novartis Investigative Site

    Dresden, 01129

  • Novartis Investigative Site

    Düren, 52349

  • Novartis Investigative Site

    Düsseldorf, 40211

  • Novartis Investigative Site

    Düsseldorf, 40489

  • Novartis Investigative Site

    Eisenach, 99817

  • Novartis Investigative Site

    Elsterwerda, 04910

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, Rhineland-Palatinate, 45127

  • Novartis Investigative Site

    Essen, 45138

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Essen, 45276

  • Novartis Investigative Site

    Essen, 45277

  • Novartis Investigative Site

    Essen, 45355

  • Novartis Investigative Site

    Essen, 45359

  • Novartis Investigative Site

    Föhren, 54343

  • Novartis Investigative Site

    Frankenberg (Eder), 35066

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt am Main, 60313

  • Novartis Investigative Site

    Freiburg im Breisgau, 79104

  • Novartis Investigative Site

    Freudenberg, 57258

  • Novartis Investigative Site

    Fürstenwalde, 15517

  • Novartis Investigative Site

    Garmisch-Partenkirchen, 82467

  • Novartis Investigative Site

    Gauting, 82131

  • Novartis Investigative Site

    Geesthacht, Schleswig-Holstein, 12502

  • Novartis Investigative Site

    Giessen, 35390

  • Novartis Investigative Site

    Gifhorn, 38518

  • Novartis Investigative Site

    Goch, 47574

  • Novartis Investigative Site

    Görlitz, 02826

  • Novartis Investigative Site

    Gummersbach, 51343

  • Novartis Investigative Site

    Gütersloh, 33330

  • Novartis Investigative Site

    Hagen, 58089

  • Novartis Investigative Site

    Halberstadt, 38820

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 20253

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 20357

  • Novartis Investigative Site

    Hamburg, 22143

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hamburg, 22335

  • Novartis Investigative Site

    Hamburg, 22527

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30159

  • Novartis Investigative Site

    Hanover, 30163

  • Novartis Investigative Site

    Hanover, 30173

  • Novartis Investigative Site

    Hanover, 30419

  • Novartis Investigative Site

    Heidelberg, 69117

  • Novartis Investigative Site

    Hettstedt, 06333

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Hoyerswerda, 02977

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Jerichow, 39319

  • Novartis Investigative Site

    Kamen, 59174

  • Novartis Investigative Site

    Karlsruhe, 76199

  • Novartis Investigative Site

    Kassel, 34117

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Kleve, 47533

  • Novartis Investigative Site

    Koblenz, North Rhine-Westphalia, 56068

  • Novartis Investigative Site

    Köthen, 06366

  • Novartis Investigative Site

    Landau-Pfalz, 76829

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04109

  • Novartis Investigative Site

    Leipzig, 04207

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Leipzig, 04357

  • Novartis Investigative Site

    Leonberg, 71229

  • Novartis Investigative Site

    Leverkusen, 51379

  • Novartis Investigative Site

    Limburgerhof, 67117

  • Novartis Investigative Site

    Löhne, 32584

  • Novartis Investigative Site

    Lübeck, 23554

  • Novartis Investigative Site

    Lüdenscheid, 58507

  • Novartis Investigative Site

    Ludwigsburg, 71640

  • Novartis Investigative Site

    Ludwigshafen, 67061

  • Novartis Investigative Site

    Ludwigshafen, 67067

  • Novartis Investigative Site

    Magdeburg, 39112

  • Novartis Investigative Site

    Marburg, 35033

  • Novartis Investigative Site

    Marburg, 35037

  • Novartis Investigative Site

    Marburg, D-35037

  • Novartis Investigative Site

    Mayen, 56727

  • Novartis Investigative Site

    Meine, 38527

  • Novartis Investigative Site

    Meissen, 01662

  • Novartis Investigative Site

    Menden, 58706

  • Novartis Investigative Site

    Minden, 32423

  • Novartis Investigative Site

    Mittweida, 09648

  • Novartis Investigative Site

    Mülheim, 45468

  • Novartis Investigative Site

    München, 80335

  • Novartis Investigative Site

    München, 80802

  • Novartis Investigative Site

    Münnerstadt, 97702

  • Novartis Investigative Site

    Neu-Isenburg, 63263

  • Novartis Investigative Site

    Neu-Ulm, 89231

  • Novartis Investigative Site

    Neunkirchen, 66539

  • Novartis Investigative Site

    Neuss, 41462

  • Novartis Investigative Site

    Neuwied, 56564

  • Novartis Investigative Site

    Northeim, 37154

  • Novartis Investigative Site

    Nuremberg, 90443

  • Novartis Investigative Site

    Nuremberg, 90478

  • Novartis Investigative Site

    Obermichelbach, 90587

  • Novartis Investigative Site

    Oschatz, 04758

  • Novartis Investigative Site

    Oschersleben, 39387

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Papenburg, 26871

  • Novartis Investigative Site

    Passau, 94032

  • Novartis Investigative Site

    Peine, Lower Saxony, 31224

  • Novartis Investigative Site

    Plauen, 08523

  • Novartis Investigative Site

    Potsdam, 14467

  • Novartis Investigative Site

    Potsdam, 14469

  • Novartis Investigative Site

    Prien A. Chiemsee, 83209

  • Novartis Investigative Site

    Radebeul, 01445

  • Novartis Investigative Site

    Ratingen, 40878

  • Novartis Investigative Site

    Raubach, 56316

  • Novartis Investigative Site

    Reinfeld, 23858

  • Novartis Investigative Site

    Rheine, 48431

  • Novartis Investigative Site

    Rodenbach, 67688

  • Novartis Investigative Site

    Roth, 91154

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Rüsselsheim am Main, 65428

  • Novartis Investigative Site

    Saalfeld, 07318

  • Novartis Investigative Site

    Saarbrücken, 66111

  • Novartis Investigative Site

    Schleswig, 24837

  • Novartis Investigative Site

    Schwabach, 91126

  • Novartis Investigative Site

    Schwedt, 16303

  • Novartis Investigative Site

    Schwerin, 19055

  • Novartis Investigative Site

    Schwetzingen, 68723

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Sinsheim, 74889

  • Novartis Investigative Site

    Solingen, 42651

  • Novartis Investigative Site

    Solingen, 42665

  • Novartis Investigative Site

    Solingen, 42697

  • Novartis Investigative Site

    Sonneberg, 96515

  • Novartis Investigative Site

    Strausberg, 15344

  • Novartis Investigative Site

    Teuchern, 06682

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Wardenburg, 26203

  • Novartis Investigative Site

    Warendorf, North Rhine-Westphalia, 48231

  • Novartis Investigative Site

    Weilheim, 82362

  • Novartis Investigative Site

    Welzheim, 73642

  • Novartis Investigative Site

    Westerkappeln, 49492

  • Novartis Investigative Site

    Wiesloch, 69168

  • Novartis Investigative Site

    Wissen, 57537

  • Novartis Investigative Site

    Witten, 58452

  • Novartis Investigative Site

    Wolfsburg, 38448

  • Novartis Investigative Site

    Wöllstein, 55597

  • Novartis Investigative Site

    Zerbst, 39261

Other trials in Germany

Italy55 sites

  • Novartis Investigative Site

    Ancona, AN, 60128

  • Novartis Investigative Site

    Arzignano, VI, 36071

  • Novartis Investigative Site

    Avellino, AV, 83100

  • Novartis Investigative Site

    Bari, BA, 70123

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Bussolengo, VR, 37012

  • Novartis Investigative Site

    Busto Arsizio, VA, 21052

  • Novartis Investigative Site

    Caltanissetta, CL, 93100

  • Novartis Investigative Site

    Campobasso, CB, 86100

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Catania, CT, 95122

  • Novartis Investigative Site

    Catania, CT, 95126

  • Novartis Investigative Site

    Cittadella, PD, 35013

  • Novartis Investigative Site

    Feltre, BL, 32032

  • Novartis Investigative Site

    Florence, FI, 50122

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Forlì, FC, 47100

  • Novartis Investigative Site

    Genova, GE, 16100

  • Novartis Investigative Site

    Lido di Camaiore, LU, 55041

  • Novartis Investigative Site

    Livorno, LI, 57124

  • Novartis Investigative Site

    Lodi, LO, 26900

  • Novartis Investigative Site

    Marcianise, CE, 81025

  • Novartis Investigative Site

    Montebelluna, TV, 31044

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Nuoro, NU, 08100

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Piacenza, PC, 29100

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Pordenone, PN, 33170

  • Novartis Investigative Site

    Riccione, RN, 47838

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00163

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Romano di Lombardia, BG, 24058

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Saluzzo, CN, 12037

  • Novartis Investigative Site

    San Pietro Vernotico, BR, 72027

  • Novartis Investigative Site

    San Severo, FG, 71016

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Sondalo, SO, 23035

  • Novartis Investigative Site

    Telese Terme, BN, 82037

  • Novartis Investigative Site

    Terlizzi, BA, 70038

  • Novartis Investigative Site

    Terni, TR, 05100

  • Novartis Investigative Site

    Torino, 10149

  • Novartis Investigative Site

    Triggiano, BA, 70019

  • Novartis Investigative Site

    Vicenza, VI, 36100

  • Novartis Investigative Site

    Vittorio Veneto, TV, 31029

  • Novartis Investigative Site

    Voghera, PV, 27058

Other trials in Italy

United Kingdom44 sites

  • Novartis Investigative Site

    Axbridge, Somerset, BS26 2BJ

  • Novartis Investigative Site

    Aylesbury, Bucks, HP22 5LB

  • Novartis Investigative Site

    Barry, Vale Of Glamorgan, CF63 1BA

  • Novartis Investigative Site

    Bath, England, BA2 3HT

  • Novartis Investigative Site

    Bexhill-on-Sea, TN40 1JJ

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD9 6RJ

  • Novartis Investigative Site

    Bristol, BS10 6SP

  • Novartis Investigative Site

    Bristol, BS48 1BZ

  • Novartis Investigative Site

    Burbage, Leicester, LE10 2SE

  • Novartis Investigative Site

    Cardiff, CF5 4AD

  • Novartis Investigative Site

    Chadderton, OL9 0LH

  • Novartis Investigative Site

    Cheshire, CW1 4QJ

  • Novartis Investigative Site

    Chesterfield, S40 4AA

  • Novartis Investigative Site

    Chippenham, SN14 6GT

  • Novartis Investigative Site

    Coventry, CV6 4DD

  • Novartis Investigative Site

    Crawley, West Sussex, RH10 7DX

  • Novartis Investigative Site

    Daventry, Northamptonshire, NN11 4DY

  • Novartis Investigative Site

    Fowey, Cornwall, PL23 1DT

  • Novartis Investigative Site

    Frome, Somerset, BA11 2FH

  • Novartis Investigative Site

    Hamilton, ML3 8AA

  • Novartis Investigative Site

    Havant, Hampshire, PO9 1DQ

  • Novartis Investigative Site

    Lancashire, FY3 7EN

  • Novartis Investigative Site

    Liskeard, Cornwall, PL14 3XA

  • Novartis Investigative Site

    Manchester, M8 9JT

  • Novartis Investigative Site

    Motherwell, ML1 3JX

  • Novartis Investigative Site

    Oldham, OL9 8NH

  • Novartis Investigative Site

    Penzance, Cornwall, TR18 AJH

  • Novartis Investigative Site

    Plymouth, PL5 3JB

  • Novartis Investigative Site

    Redruth, Cornwall

  • Novartis Investigative Site

    Royal Leamington Spa, Warwickshire, CV32 4RA

  • Novartis Investigative Site

    Shrewsbury, SY38XQ

  • Novartis Investigative Site

    Sneinton, Nottingham, NG3 7DQ

  • Novartis Investigative Site

    South Shields, Tyne and Wear, NE34 0PL

  • Novartis Investigative Site

    South Yorkshire, DN9 1EP

  • Novartis Investigative Site

    St Austell, Cornwall, PL26 7RL

  • Novartis Investigative Site

    Stockton-on-Tees, TS19 8PE

  • Novartis Investigative Site

    Strensall, Yorkshire, YO32 5UA

  • Novartis Investigative Site

    Taunton, Somerset, TA1 5DA

  • Novartis Investigative Site

    Torpoint, Cornwall, PL11 2TB

  • Novartis Investigative Site

    Trowbridge, Wiltshire, BA14 8QA

  • Novartis Investigative Site

    Vale of Glanmorgan, CF63 4AR

  • Novartis Investigative Site

    Watford, WD25 7NL

  • Novartis Investigative Site

    Wiltshire, SN15 2SB

  • Novartis Investigative Site

    Wishaw, ML2 0DP

Other trials in United Kingdom

Spain39 sites

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Badalona, Barcelona, 08917

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Benidorm, Valencia, 03501

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

  • Novartis Investigative Site

    Canet de Mar, Catalonia, 08360

  • Novartis Investigative Site

    Centelles, Barcelona, 08540

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Madrid, Madrid, Communidad de, 28022

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Mallorca, Balearic Islands, 07198

  • Novartis Investigative Site

    Marbella, Andalusia, 29600

  • Novartis Investigative Site

    Marbella, Andalusia, 29603

  • Novartis Investigative Site

    Mataró, Barcelona, 08303

  • Novartis Investigative Site

    Mérida, Extremadura, 06800

  • Novartis Investigative Site

    Móstoles, Madrid, Communidad de, 28933

  • Novartis Investigative Site

    Motril, Granada, 18600

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07014

  • Novartis Investigative Site

    Ponferrada, Castille and León, 24400

  • Novartis Investigative Site

    Port de Sagunt, Valencia, 46520

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007

  • Novartis Investigative Site

    Sant Boi de Llobregat, Catalonia, 08830

  • Novartis Investigative Site

    Sant Joan Despí, Barcelona, 08970

  • Novartis Investigative Site

    Santiago de Compostela, 15706

  • Novartis Investigative Site

    Valdemoro, Madrid, 28342

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Valencia, Valencia, 46015

  • Novartis Investigative Site

    Valencia, Valencia, 46017

  • Novartis Investigative Site

    Valencia, Valencia, 46019

  • Novartis Investigative Site

    Vic, Barcelona, 08500

  • Novartis Investigative Site

    Vic, Catalonia, 08500

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Belgium35 sites

  • Novartis Investigative Site

    Antwerp, 2060

  • Novartis Investigative Site

    Balen, 2490

  • Novartis Investigative Site

    Braine-l'Alleud, 1420

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Éghezée, 5310

  • Novartis Investigative Site

    Erpent, 5100

  • Novartis Investigative Site

    Geraardsbergen, 9500

  • Novartis Investigative Site

    Gilly, 6060

  • Novartis Investigative Site

    Gosselies, BEL, 6041

  • Novartis Investigative Site

    Gozée, BEL, 6534

  • Novartis Investigative Site

    Halen, 3545

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Heusy, 4802

  • Novartis Investigative Site

    Ieper, 8900

  • Novartis Investigative Site

    Knokke-Heist, 8300

  • Novartis Investigative Site

    Lebbeke, 9280

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Maaseik, 3680

  • Novartis Investigative Site

    Malmedy, 4960

  • Novartis Investigative Site

    Mechelen, 2800

  • Novartis Investigative Site

    Melsbroek, 1820

  • Novartis Investigative Site

    Merksem, 2170

  • Novartis Investigative Site

    Montegnée, 4420

  • Novartis Investigative Site

    Natoye, 5360

  • Novartis Investigative Site

    Paal-Beringen, 3583

  • Novartis Investigative Site

    Ronse, 9600

  • Novartis Investigative Site

    Saint-Médard, 6887

  • Novartis Investigative Site

    Seraing, 4100

  • Novartis Investigative Site

    Tournai, 7500

  • Novartis Investigative Site

    Verviers, 4800

  • Novartis Investigative Site

    Vilvoorde, 1800

  • Novartis Investigative Site

    Zichem, BEL, 3271

  • Novartis Investigative Site

    Zottegem, 9620

Other trials in Belgium

Czechia29 sites

  • Novartis Investigative Site

    Boskovice, Czech Republic, 680 01

  • Novartis Investigative Site

    Brandýs nad Labem, Czech Republic, 25001

  • Novartis Investigative Site

    Brno-Královo Pole, Czech Republic, 61200

  • Novartis Investigative Site

    Cvikov, Czech Republic, 471 54

  • Novartis Investigative Site

    Havlíčkův Brod, Czech Republic, 580 01

  • Novartis Investigative Site

    Jirkov, Czech Republic, 43111

  • Novartis Investigative Site

    Kuřim, Czech Republic, 66434

  • Novartis Investigative Site

    Liberec, Czech Republic, 460 01

  • Novartis Investigative Site

    Lovosice, Czech Republic, 410 02

  • Novartis Investigative Site

    Neratovice, Czech Republic, 27711

  • Novartis Investigative Site

    Ostrava, Czech Republic, 708 68

  • Novartis Investigative Site

    Pardubice, Czech Republic, 530 09

  • Novartis Investigative Site

    Pilsen, Czech Republic, 33011

  • Novartis Investigative Site

    Pilsen, Czech Republic, 331 01

  • Novartis Investigative Site

    Prague, Czech Republic, 108 00

  • Novartis Investigative Site

    Prague, Czech Republic, 130 00

  • Novartis Investigative Site

    Prague, Czech Republic, 140 46

  • Novartis Investigative Site

    Prague, Czech Republic, 142 00

  • Novartis Investigative Site

    Prague, Czech Republic, 14800

  • Novartis Investigative Site

    Prague, Czech Republic, 163 00

  • Novartis Investigative Site

    Prague, Czech Republic, 19000

  • Novartis Investigative Site

    Prague, 182 00

  • Novartis Investigative Site

    Rokycany, Czech Republic, 337 22

  • Novartis Investigative Site

    Rudná, Czech Republic, 25219

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Třebíč, Czech Republic, 674 01

  • Novartis Investigative Site

    Varnsdorf, Czech Republic, 40747

  • Novartis Investigative Site

    Žatec, Czech Republic, 438 01

  • Novartis Investigative Site

    Znojmo, Czech Republic, 672 01

Other trials in Czechia

France16 sites

  • Novartis Investigative Site

    Briis-sous-Forges, 91640

  • Novartis Investigative Site

    Chamalières, 63400

  • Novartis Investigative Site

    Châtellerault, 86100

  • Novartis Investigative Site

    Forbach, 57600

  • Novartis Investigative Site

    L'Aigle, 61305

  • Novartis Investigative Site

    La Bouëxière, 35340

  • Novartis Investigative Site

    Marseille, 13003

  • Novartis Investigative Site

    Montpellier, 34080

  • Novartis Investigative Site

    Mûrs-Erigné, 49610

  • Novartis Investigative Site

    Nice, 06000

  • Novartis Investigative Site

    Saint-Jean-de-Luz, 64500

  • Novartis Investigative Site

    Saint-Laurent-du-Var, 06721

  • Novartis Investigative Site

    Saint-Pierre, 97448

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Toulon, 83000

  • Novartis Investigative Site

    Tours, Indre Et Loire, 37044

Other trials in France

Russia15 sites

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Kemerovo, 650029

  • Novartis Investigative Site

    Moscow, 101990

  • Novartis Investigative Site

    Moscow, 125315

  • Novartis Investigative Site

    N.Novgorod, 603126

  • Novartis Investigative Site

    Novosibirsk, 630099

  • Novartis Investigative Site

    Ryazan, 390026

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Smolensk, 214019

  • Novartis Investigative Site

    Tomsk, 634050

  • Novartis Investigative Site

    Ufa, 450000

  • Novartis Investigative Site

    Yaroslavl, 150003

Other trials in Russia

Hungary13 sites

  • Novartis Investigative Site

    Cegléd, 2700

  • Novartis Investigative Site

    Debrecen, 4026

  • Novartis Investigative Site

    Győr, HUN, 9024

  • Novartis Investigative Site

    Hatvan, 3000

  • Novartis Investigative Site

    Komárom, 2900

  • Novartis Investigative Site

    Makó, 6900

  • Novartis Investigative Site

    Mátészalka, 4700

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Pécs, 7635

  • Novartis Investigative Site

    Százhalombatta, HUN, 2440

  • Novartis Investigative Site

    Szeged, 6722

  • Novartis Investigative Site

    Tatabánya, 2800

  • Novartis Investigative Site

    Törökbálint, 2045

Other trials in Hungary

Slovakia13 sites

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01

  • Novartis Investigative Site

    Kráľovský Chlmec, 077 01

  • Novartis Investigative Site

    Levice, 034 01

  • Novartis Investigative Site

    Liptovský Hrádok, Slovak Republic, 033 01

  • Novartis Investigative Site

    Námestovo, Slovensko, 02901

  • Novartis Investigative Site

    Poprad, 058 01

  • Novartis Investigative Site

    Prešov, 080 01

  • Novartis Investigative Site

    Prešov, 08001

  • Novartis Investigative Site

    Šaľa, 927 01

  • Novartis Investigative Site

    Štúrovo, 943 11

  • Novartis Investigative Site

    Trnava, 917 75

  • Novartis Investigative Site

    Vráble, 95201

Other trials in Slovakia

Sweden11 sites

  • Novartis Investigative Site

    Gothenburg, 413 46

  • Novartis Investigative Site

    Gustavsberg, 134 44

  • Novartis Investigative Site

    Helsingborg, 252 25

  • Novartis Investigative Site

    Höllviken, 236 32

  • Novartis Investigative Site

    Kungshamn, 456 31

  • Novartis Investigative Site

    Limhamn, 216 43

  • Novartis Investigative Site

    Linköping, Östergötland County, 587 58

  • Novartis Investigative Site

    Lund, 222 22

  • Novartis Investigative Site

    Råå, 252 70

  • Novartis Investigative Site

    Umeå, 907 40

  • Novartis Investigative Site

    Västra Frölunda, 421 44

Other trials in Sweden

Austria9 sites

  • Novartis Investigative Site

    Amstetten, 3300

  • Novartis Investigative Site

    Feldkirch, 6800

  • Novartis Investigative Site

    Hallein, 5400

  • Novartis Investigative Site

    Kirchdorf an der Krems, 4560

  • Novartis Investigative Site

    Leoben, 8700

  • Novartis Investigative Site

    Linz, 4020

  • Novartis Investigative Site

    Perg, 4320

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Wels, 4600

Other trials in Austria

Lithuania9 sites

  • Novartis Investigative Site

    Alytus, LT-62114

  • Novartis Investigative Site

    Kaunas, LT, LT-50128

  • Novartis Investigative Site

    Kaunas, 3007

  • Novartis Investigative Site

    Klaipėda, LT-92288

  • Novartis Investigative Site

    Utena, LT-28151

  • Novartis Investigative Site

    Vilnius, LTU, LT-10207

  • Novartis Investigative Site

    Vilnius, LT, 01117

  • Novartis Investigative Site

    Vilnius, 06122

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Norway9 sites

  • Novartis Investigative Site

    Førde, 6800

  • Novartis Investigative Site

    Kløfta, 2040

  • Novartis Investigative Site

    Lierskogen, 3420

  • Novartis Investigative Site

    Oslo, 0190

  • Novartis Investigative Site

    Oslo, 0953

  • Novartis Investigative Site

    Skedsmokorset, 2020

  • Novartis Investigative Site

    Skien, 3734

  • Novartis Investigative Site

    Stavanger, 4005

  • Novartis Investigative Site

    Tananger, 4056

Other trials in Norway

Portugal9 sites

  • Novartis Investigative Site

    Aveiro, 3814-501

  • Novartis Investigative Site

    Barcelos, 4754-909

  • Novartis Investigative Site

    Coimbra, 3041-853

  • Novartis Investigative Site

    Guimarães, 4835-044

  • Novartis Investigative Site

    Lisbon, 1169-024

  • Novartis Investigative Site

    Lisbon, 1349-019

  • Novartis Investigative Site

    Porto, 4200 319

  • Novartis Investigative Site

    Vila Franca de Xira, 2600-009

  • Novartis Investigative Site

    Vila Nova de Gaia, 440-230

Other trials in Portugal

Poland8 sites

  • Novartis Investigative Site

    Bialystok, 15-044

  • Novartis Investigative Site

    Krakow, 31-024

  • Novartis Investigative Site

    Nowy Dwór Mazowiecki, 05-100

  • Novartis Investigative Site

    Ostrów Wielkopolski, 63-400

  • Novartis Investigative Site

    Piła, 64-920

  • Novartis Investigative Site

    Sopot, 81-741

  • Novartis Investigative Site

    Warsaw, 01-138

  • Novartis Investigative Site

    Wroclaw, 51-162

Other trials in Poland

Romania8 sites

  • Novartis Investigative Site

    Bacau, 600252

  • Novartis Investigative Site

    Bragadiru, 077025

  • Novartis Investigative Site

    Bucharest, District 3, 030303

  • Novartis Investigative Site

    Constanța, 900591

  • Novartis Investigative Site

    Iași, Jud. Iasi, 700115

  • Novartis Investigative Site

    Râmnicu Vâlcea, 240564

  • Novartis Investigative Site

    Suceava, 720284

  • Novartis Investigative Site

    Timișoara, 300736

Other trials in Romania

Latvia7 sites

  • Novartis Investigative Site

    Balvi, LVA, 4501

  • Novartis Investigative Site

    Daugavpils, LV-5401

  • Novartis Investigative Site

    Jūrmala, LVA, LV-2015

  • Novartis Investigative Site

    Riga, LV, 1011

  • Novartis Investigative Site

    Riga, LV, LV-1038

  • Novartis Investigative Site

    Riga, LV 1002

  • Novartis Investigative Site

    Riga, LV-1001

Other trials in Latvia

Estonia6 sites

  • Novartis Investigative Site

    Paide, 72714

  • Novartis Investigative Site

    Tallinn, 10138

  • Novartis Investigative Site

    Tallinn, 10617

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tallinn, 13619

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Denmark5 sites

  • Novartis Investigative Site

    Alleroed, 3450

  • Novartis Investigative Site

    Greve, 2670

  • Novartis Investigative Site

    Haslev, 4690

  • Novartis Investigative Site

    Søborg, 2860

  • Novartis Investigative Site

    Værløse, 3500

Other trials in Denmark

Ireland4 sites

  • Novartis Investigative Site

    County Limerick, V94 F858

  • Novartis Investigative Site

    Dublin, 24

  • Novartis Investigative Site

    Dublin, DUBLIN 8

  • Novartis Investigative Site

    Dublin

Other trials in Ireland

Slovenia4 sites

  • Novartis Investigative Site

    Golnik, 4204

  • Novartis Investigative Site

    Kranj, 4000

  • Novartis Investigative Site

    Maribor, 2000

  • Novartis Investigative Site

    Murska Sobota, 9000

Other trials in Slovenia

Greece3 sites

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Serres, GR 62 100

  • Novartis Investigative Site

    Thessaloniki, GR, 564 29

Other trials in Greece

About this study

Official title: A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

Read the detailed description

The treatment epoch will last 12 weeks. The total duration of the study for each patient is 12 weeks (from randomization) plus 30 days of safety follow-up.

The study has three phases: screening phase (=wash-out period, if required), treatment phase and safety follow-up phase.

Eligible patients will be randomized to either receive glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed dose combination or to remain in their baseline therapy, in an allocation ratio of 3:1 for each cluster (Groups A, B, C, and D), based on their COPD symptoms and baseline treatment:

Group A: Patients treated with any SABA ( Short-acting β2-adrenergic agonist) and/or SAMA (Short-acting muscarinic antagonist) as monotherapy or in free or fixed dose combination (FDC) will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group B: Patients treated with any LABA (Long-acting β2-adrenergic agonist) or LAMA (Long-acting muscarinic antagonist) monotherapy and mMRC score =1 point will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group C: Patients treated with any LABA and ICS (Inhaled corticosteroid) in free or FDC will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Group D: Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Due to low recruitment in Groups A and B that would lead to a significant delay of trial completion, a protocol amendment was made in order to close the recruitment of Groups A and B at the time the randomization in Groups C and D would be completed. Recruitment of the Groups C and D continued as originally planned

Conditions
COPD
Being tested
Glycopyrronium, SABA, LABA, Indacaterol maleate and glycopyrronium bromide, LAMA
Keywords
Moderate COPD, glycopyrronium bromide, indacaterol maleate and glycopyrronium bromide FDC, NVA237, QVA149
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlycopyrroniumDrug

    Also called glycopyrronium bromide

    Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day

  • SABADrug

    Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy

  • LABADrug

    Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy

  • Indacaterol maleate and glycopyrronium bromideDrug

    Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day

  • LAMADrug

    Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy

  • SAMADrug

    Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy

  • ICSDrug

    Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy

Study groups in NCT01985334
Study groupRoleWhat they receive
A1 (any SABA and/or SAMA)ExperimentalPatients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) during 90 days of treatment
Receives: Drug: Glycopyrronium; Drug: SABA; Drug: SAMA
A2 (glycopyrronium)ExperimentalPatients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Receives: Drug: Glycopyrronium; Drug: SABA; Drug: LABA; Drug: SAMA
B1 (any LAMA or LABA and mMRC=1)ExperimentalPatients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
Receives: Drug: LABA; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: LAMA; Drug: ICS
B2 (glycopyrronium and mMRC=1)ExperimentalPatients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Receives: Drug: LABA; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: LAMA
C1 (any LABA and ICS)ExperimentalPatients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
Receives: Drug: LABA; Drug: ICS
C2 (indacaterol/glycopyrronium)ExperimentalPatients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
Receives: Drug: LABA; Drug: ICS
D1 (any LAMA or LABA and mMRC>1)ExperimentalPatients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
Receives: Drug: LAMA
D2 (indacaterol/glycopyrronium and mMRC>1)ExperimentalPatients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Receives: Drug: LAMA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

    Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

    Measured: Week 12 (Visit 4)

  2. Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

    Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

    Measured: Week 12 (Visit 4)

  3. Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

    Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

    Measured: Week 12 (Visit 4)

  4. Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

    Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

    Measured: Week 12 (Visit 4)

  5. Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

    Measured: Day 1 (baseline) and week 12

  6. Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

    Measured: Day 1 (baseline) and week 12

  7. Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

    Measured: Day 1 (baseline) and week 12

  8. Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

    Measured: Day 1 (baseline) and week 12

Secondary outcomes (8)

  1. Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

    Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

    Measured: 12 Weeks

  2. Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)

    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

    Measured: Day 1 (baseline) and week 12

  3. Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.

    Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

    Measured: 12 Weeks

  4. Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC

    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

    Measured: Day 1 (baseline) and week 12

  5. Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

    Total score of COPD Assessment Test (CAT) will be measured at baseline and at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.

    Measured: Day 1 (baseline) and Week 12

  6. Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

    The Clinical COPD Questionnaire (CCQ) is a self-administered 10-item questionnaire developed to measure clinical control in patients with COPD. Patients will be instructed to recall their experiences during the previous week. They respond to each question using a 7-point scale from 0 = asymptomatic/no imitation to 6 = extremely symptomatic/totally limited. The questionnaire is divided into 3 domains (symptoms [items 1, 2, 5, and 6] functional [items 7, 8, 9, and 10] and mental state [items 3 and 4]). The overall clinical COPD control score and the scores of the domains are calculated by adding all the scores together and dividing this sum by the number of questions.

    Thus, the overall clinical COPD control score as well as the score on each of the three domains varies between 0 (very good control) to 6 (extremely poor control).

    Measured: Day 1 (baseline) and Week 12

  7. Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

    Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.

    Measured: 12 weeks

  8. Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

    Patient-reported symptoms of COPD combined will be measured using eDiary data reported over the 12 week treatment period. The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of nights with no nighttime awakenings and percentage of days with no symptoms.

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2013 (estimated)
  2. Study start14 Feb 2014
  3. Primary completion29 Apr 2016
  4. Study completion29 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01985334
Sponsor's protocol ID
CQVA149A3401
Status last verified
Mar 2019
First submitted
4 Nov 2013
Last updated
19 Mar 2019
Data monitoring committee
No

Publications

  • Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.

    PubMed 29713156

  • Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.

    PubMed 28720132

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glycopyrronium, SABA and LABA in people with COPD, run by Novartis Pharmaceuticals at 542 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 542 sites in Germany, Italy, United Kingdom, Spain, Belgium and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (time frame: Week 12 (Visit 4)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01985334, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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