AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3SPARKNCT01120691

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

A Phase 3 study testing QVA149, NVA237 and tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 342 sites in 28 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

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
QVA149, NVA237 and tiotropium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,224 participants
Where
342 sitesin 28 countries
Study dates
Apr 2010to Jul 2012
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female adults aged ≥40 years, who had signed an informed consent form prior to initiation of any study-related procedure.
  • Patients with severe to very severe Chronic Obstructive Pulmonary Disease COPD (Stage III or IV) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
  • Current or ex-smokers with a smoking history of at least 10 pack years (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
  • Patients with a post-bronchodilator Forced Expiratory Volume in one second ( FEV1) <50% of the predicted normal value, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) <0.70 at Visit 2 (day -14). (Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol).
  • A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics.

Who cannot join

  • Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
  • Women of child-bearing potential
  • Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia.
  • Patients who had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to visit 1 or between visit 1 (Day -21) and Visit 3 (Day 1).
  • Patients who developed a COPD exacerbation during a period between visit 1 and 3 were ineligible but were permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
  • Patients who had a respiratory tract infection within 4 weeks prior to visit 1 (Day -21)
Show all 37Show fewer
  • Patients who developed an upper or lower respiratory tract infection during the screening period (up to visit 3 (Day 1) were not eligible, but were permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
  • Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
  • Patients with lung lobectomy, or lung volume reduction or lung transplantation.
  • 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, history of myocardial infarction, arrhythmia (excluding chronic stable Atrial Fibrillation (AF). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study
  • history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
  • uncontrolled hypo- or hyperthyroidism, hypokalemia or hyper adrenergic state
  • narrow-angle glaucoma
  • Symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (Patients with a Transurethral Resection of Prostate (TURP) were excluded from the study. Patients who underwent full re-section of the prostate could be considered for the study, as well as patients who were asymptomatic and stable on pharmacological treatment for the condition).
  • any condition which might have compromised patient safety or compliance, interfered with evaluation, or precluded completion of the study
  • Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 2), or onset of symptoms prior to 40 years. Patients without asthma were excluded if their eosinophil count was >600/mm3 at visit 2.
  • Patients with allergic rhinitis who used H1 antagonists or intranasal corticosteroids intermittently (treatment with a constant dose was permitted).
  • Patients with eczema (atopic), known high immunoglobulin E (IgE) levels or a known positive skin prick test in the last 5 years.
  • Patients with known history and diagnosis of alpha-1 antitrypsin deficiency.
  • Patients who were participating in the active phase of a supervised pulmonary rehabilitation program.
  • Patients with Type I or uncontrolled Type II diabetes.
  • Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or drugs of a similar class or any component thereof:
  • anticholinergic agents
  • long and short acting beta-2 agonists
  • sympathomimetic amines.
  • Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at visit 2 (Day -14) (Fridericia method) was prolonged (>450 ms for males and females) as confirmed by the central ECG assessor.
  • Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients could not be re-screened).
  • Patients who needed treatments for COPD and allied conditions after the start of the study (visit 1)
  • Patients who needed treatments for COPD and allied conditions (e.g. allergic rhinitis) unless they had been stabilized
  • Patients taking other prohibited medications
  • Patients unable to use a dry powder inhaler (e.g. single dose dry powder inhaler (SDDPI), HandiHaler® device, or pressurized Metered Dose Inhaler (MDI) (rescue medication).
  • Patients unable to use an electronic patient diary.
  • Patients who were, in the opinion of the investigator known to be unreliable or non-compliant.
  • Patients who used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of visit 1 (day -21), whichever was longer.
  • Patients who had live attenuated vaccination within 30 days prior to the screening visit or during the run-in period. Inactivated influenza vaccination, pneumococcal vaccination or any other inactivated vaccine was acceptable provided it was not administered within 48 hours prior to screening and randomization visits.
  • No additional exclusions were applied by the investigator, in order to ensure that the study population was representative of all eligible patients.

Trial locations and contacts

342 sites in 28 countries.

342 sites in 28 countries

United States53 sites

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Beaver, Pennsylvania, 15009

  • Novartis Investigative Site

    Birmingham, Alabama, 35233

  • Novartis Investigative Site

    Charleston, South Carolina, 29406-7108

  • Novartis Investigative Site

    Charlotte, North Carolina, 28207

  • Novartis Investigative Site

    Columbus, Ohio, 43213

  • Novartis Investigative Site

    Couer D'Alene, Idaho, 83814

  • Novartis Investigative Site

    Dallas, Texas, 75216

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Erie, Pennsylvania, 16508

  • Novartis Investigative Site

    Fairhope, Alabama, 36532

  • Novartis Investigative Site

    Florence, Alabama, 35630

  • Novartis Investigative Site

    Florence, Kentucky, 41042

  • Novartis Investigative Site

    Fort Worth, Texas, 76104

  • Novartis Investigative Site

    Fort Worth, Texas, 76107

  • Novartis Investigative Site

    Fridley, Minnesota, 55432

  • Novartis Investigative Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Gainesville, Florida, 32608

  • Novartis Investigative Site

    Great Neck, New York, 11021

  • Novartis Investigative Site

    Green Bay, Wisconsin, 54311

  • Novartis Investigative Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Homewood, Alabama, 35209-6870

  • Novartis Investigative Site

    Jasper, Alabama, 35501

  • Novartis Investigative Site

    Las Vegas, Nevada, 89119

  • Novartis Investigative Site

    Louisville, Kentucky, 40206

  • Novartis Investigative Site

    Massapequa, New York, 11758

  • Novartis Investigative Site

    Medford, Oregon, 97504-8741

  • Novartis Investigative Site

    Miami, Florida, 33125

  • Novartis Investigative Site

    Missoula, Montana, 59804

  • Novartis Investigative Site

    Normal, Illinois, 61761

  • Novartis Investigative Site

    Opelousas, Louisiana, 70570

  • Novartis Investigative Site

    Ozark, Missouri, 65721

  • Novartis Investigative Site

    Palo Alto, California, 94304-1207

  • Novartis Investigative Site

    Papillion, Nebraska, 68046

  • Novartis Investigative Site

    Pensacola, Florida, 32503

  • Novartis Investigative Site

    Pine Bluff, Arkansas, 71603

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15243

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigative Site

    Reno, Nevada, 89520

  • Novartis Investigative Site

    River Forest, Illinois, 60305

  • Novartis Investigative Site

    Riverside, California, 92506

  • Novartis Investigative Site

    Saint Charles, Missouri, 63301

  • Novartis Investigative Site

    Salem, Virginia, 24153

  • Novartis Investigative Site

    Salt Lake City, Utah, 84107

  • Novartis Investigative Site

    San Diego, California, 92101

  • Novartis Investigative Site

    San Diego, California, 92103-8415

  • Novartis Investigative Site

    San Diego, California, 92120

  • Novartis Investigative Site

    Spartanburg, South Carolina, 29303

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Stockton, California, 95207

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Wilmington, North Carolina, 28401

Other trials in United States

Germany49 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Berlin, Germany, 10117

  • Novartis Investigative Site

    Berlin, Germany, 10969

  • Novartis Investigative Site

    Berlin, Germany, 14050

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 10717

  • Novartis Investigative Site

    Berlin, 12043

  • Novartis Investigative Site

    Berlin, 12165

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 13086

  • Novartis Investigative Site

    Berlin, D-12165

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Dresden, Germany, 01307

  • Novartis Investigative Site

    Duisburg, 47057

  • Novartis Investigative Site

    Düren, 52349

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Freudenberg, 57258

  • Novartis Investigative Site

    Fulda, 36039

  • Novartis Investigative Site

    Gelsenkirchen, 45879

  • Novartis Investigative Site

    Gummersbach, 51643

  • Novartis Investigative Site

    Hagen, 59065

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hanover, 30167

  • Novartis Investigative Site

    Heidelberg, Germany, 69117

  • Novartis Investigative Site

    Homburg, 66424

  • Novartis Investigative Site

    Kiel, 24148

  • Novartis Investigative Site

    Koblenz, North Rhine-Westphalia, 56068

  • Novartis Investigative Site

    Langenfeld, 40764

  • Novartis Investigative Site

    Leipzig, Germany, 04207

  • Novartis Investigative Site

    Leipzig, 04357

  • Novartis Investigative Site

    Lübeck, 23558

  • Novartis Investigative Site

    Marburg, Germany, 35037

  • Novartis Investigative Site

    München, Germany, 80331

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Oranienburg, 16515

  • Novartis Investigative Site

    Potsdam, Germany, 14467

  • Novartis Investigative Site

    Radebeul, 01445

  • Novartis Investigative Site

    Reinfeld, 23858

  • Novartis Investigative Site

    Saarbrücken, 66111

  • Novartis Investigative Site

    Schwerte, 58239

  • Novartis Investigative Site

    Schwetzingen, 68723

  • Novartis Investigative Site

    Solingen, 42651

  • Novartis Investigative Site

    Stade, 21680

  • Novartis Investigative Site

    Teterow, Germany, 17166

  • Novartis Investigative Site

    Wissen, 57537

Other trials in Germany

Argentina32 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, B1842DID

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, B1878FNR

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, B2705XAE

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, B8000XAV

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1013AAR

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1115AAB

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1120AAC

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1122AAK

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1125ABE

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1405BCH

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1425AUA

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1425BEA

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires

  • Novartis Investigative Site

    Buenos Aires, 1428

  • Novartis Investigative Site

    Buenos Aires, B6500EZL

  • Novartis Investigative Site

    Buenos Aires, C1186ACB

  • Novartis Investigative Site

    Buenos Aires, C1440BRR

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, C1424BSF

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH

  • Novartis Investigative Site

    Corrientes, Corrientes Province, 3400

  • Novartis Investigative Site

    La Plata, Buenos Aires, 1900

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, B7600FZN

  • Novartis Investigative Site

    Mendoza, Mendoza Province, 5500

  • Novartis Investigative Site

    Mendoza, Mendoza Province, M5500CCG

  • Novartis Investigative Site

    Paraná Entre Ríos, Argentina, 3100

  • Novartis Investigative Site

    Rosario, Santa Fe Province, C2000DSR

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

  • Novartis Investigative Site

    San Isidro, Buenos Aires, B1609EEO

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000DGF

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000FIL

Other trials in Argentina

Czechia18 sites

  • Novartis Investigative Site

    Český Krumlov, Czech Republic, 381 01

  • Novartis Investigative Site

    Cvikov, Czech Republic, 471 54

  • Novartis Investigative Site

    Havlíčkův Brod, Czech Republic, 580 01

  • Novartis Investigative Site

    Jaroměř, Czech Republic, 551 01

  • Novartis Investigative Site

    Karlovy Vary, Czech Republic, 360 66

  • Novartis Investigative Site

    Kroměříž, Czech Republic, 767 55

  • Novartis Investigative Site

    Kutná Hora, Czech Republic, 284 01

  • Novartis Investigative Site

    Kyjov, Czech Republic, 697 01

  • Novartis Investigative Site

    Liberec, Czech Republic, 460 01

  • Novartis Investigative Site

    Pardubice, Czech Republic, 530 09

  • Novartis Investigative Site

    Prague, Czech Republic, 108 00

  • Novartis Investigative Site

    Prague, Czech Republic, 142 00

  • Novartis Investigative Site

    Prague, Czech Republic, 198 00

  • Novartis Investigative Site

    Rokycany, Czech Republic, 337 22

  • Novartis Investigative Site

    Strakonice, Czech Republic, 38601

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Žatec, Czech Republic, 438 01

  • Novartis Investigative Site

    Znojmo, Czech Republic, 669 02

Other trials in Czechia

United Kingdom18 sites

  • Novartis Investigative Site

    Blackpool, FY3 8NR

  • Novartis Investigative Site

    Bradford, BD9 6RJ

  • Novartis Investigative Site

    Bristol, BS10 5NB

  • Novartis Investigative Site

    Chertsey, Surrey, KT16 0PZ

  • Novartis Investigative Site

    Coventry, CV6 4DD

  • Novartis Investigative Site

    Gillingham, ME7 5NY

  • Novartis Investigative Site

    Glasgow, G21 3UW

  • Novartis Investigative Site

    Hereford, HR1 2ER

  • Novartis Investigative Site

    Huntingdon, PE29 6NT

  • Novartis Investigative Site

    London, NW3 2PR

  • Novartis Investigative Site

    Manchester, M23 9QZ

  • Novartis Investigative Site

    Merseyside, CH49 5PE

  • Novartis Investigative Site

    Portsmouth, PO6 3AD

  • Novartis Investigative Site

    Sneinton, Nottingham, NG3 7DQ

  • Novartis Investigative Site

    Stockton, Cleveland, TS19 8PE

  • Novartis Investigative Site

    Taunton, Somerset, TA1 3JL

  • Novartis Investigative Site

    Telford, TF1 6TF

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Russia17 sites

  • Novartis Investigative Site

    Barnaul, 656045

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Kazan', Tatarstan Republic, 420015

  • Novartis Investigative Site

    Moscow, 105229

  • Novartis Investigative Site

    Moscow, 127018

  • Novartis Investigative Site

    Rostov-on-Don, 344090

  • Novartis Investigative Site

    Ryazan, 390026

  • Novartis Investigative Site

    S.-Petersburg, 196247

  • Novartis Investigative Site

    Saint Petersburg, 191015

  • Novartis Investigative Site

    Saint Petersburg, 193312

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 198013

  • Novartis Investigative Site

    Saint Petersburg, 198044

  • Novartis Investigative Site

    Samara, 443079

  • Novartis Investigative Site

    Yaroslavl, 150010

  • Novartis Investigative Site

    Yekaterinburg, 620109

Other trials in Russia

Italy16 sites

  • Novartis Investigative Site

    Abano Terme, PD, 35031

  • Novartis Investigative Site

    Arenzano, GE, 16011

  • Novartis Investigative Site

    Catania, CT, 95125

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Milan, MI, 20121

  • Novartis Investigative Site

    Montecchio Maggiore, VI, 36075

  • Novartis Investigative Site

    Osimo, AN, 60027

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Pietra Ligure, SV, 17027

  • Novartis Investigative Site

    Pisa, Italy, 56124

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Riccione, RN, 47838

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Siena, SI, 53100

Other trials in Italy

India14 sites

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 002

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641004

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641014

  • Novartis Investigative Site

    Hyderabad, A.p., 500 001

  • Novartis Investigative Site

    Hyderbabd, Andhra Pradesh, 500 029

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302004

  • Novartis Investigative Site

    Mysore, Karnataka, 570004

  • Novartis Investigative Site

    Nagpur - Maharastra, India, 400 012

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029

  • Novartis Investigative Site

    Panjim, 403002

  • Novartis Investigative Site

    Pune, Maharashtra, 411 014

  • Novartis Investigative Site

    Secunderabad, 500002

  • Novartis Investigative Site

    Trivandrum, India, 695011

Other trials in India

Netherlands13 sites

  • Novartis Investigative Site

    Almelo, Netherlands, 7609 PP

  • Novartis Investigative Site

    Breda, Netherlands, 4819 EV

  • Novartis Investigative Site

    Dordrecht, 3318AT

  • Novartis Investigative Site

    Drachten, 9200 DA

  • Novartis Investigative Site

    Enschede, Netherlands, 7513 ER

  • Novartis Investigative Site

    Harderwijk, Netherlands, 3840 AC

  • Novartis Investigative Site

    Helmond, Netherlands, 5707 HA

  • Novartis Investigative Site

    Hoofddorp, 2134 TM

  • Novartis Investigative Site

    Hoorn, 1624 NP

  • Novartis Investigative Site

    Leeuwarden, 8934 AD

  • Novartis Investigative Site

    Roermond, 6043 CV

  • Novartis Investigative Site

    Veldhoven, 5504 DB

  • Novartis Investigative Site

    Voorburg, 2275 CX

Other trials in Netherlands

Hungary11 sites

  • Novartis Investigative Site

    Baja, 6500

  • Novartis Investigative Site

    Budapest, 1125

  • Novartis Investigative Site

    Cegléd, Hungary, 2700

  • Novartis Investigative Site

    Debrecen, Hungary, 4032

  • Novartis Investigative Site

    Deszk, 6772

  • Novartis Investigative Site

    Eger, 3300

  • Novartis Investigative Site

    Makó, 6900

  • Novartis Investigative Site

    Mosonmagyaróvár, 9200

  • Novartis Investigative Site

    Sopron, 9400

  • Novartis Investigative Site

    Szarvas, Hungary, 5540

  • Novartis Investigative Site

    Szekszárd, 7100

Other trials in Hungary

Canada10 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7

  • Novartis Investigative Site

    Joliette, Quebec, J6E 6J2

  • Novartis Investigative Site

    Laval, Quebec, H7S 2M5

  • Novartis Investigative Site

    Mississauga, Ontario, L5M 2V8

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1T8

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1G 3Z4

  • Novartis Investigative Site

    Québec, Quebec, G1P 1J6

  • Novartis Investigative Site

    Saint Romuald, Quebec, G6W 5M6

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

Israel9 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Beersheba, 84101

  • Novartis Investigative Site

    Jerusalem, 91031

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Kfar Saba, 44281

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Rehovot, 76100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Slovakia9 sites

  • Novartis Investigative Site

    Banská Bystrica, Slovak Republic, 975 17

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01

  • Novartis Investigative Site

    Humenné, Slovak Republic, 066 01

  • Novartis Investigative Site

    Košice, Slovakia, 040 01

  • Novartis Investigative Site

    Kráľovský Chlmec, Slovakia, 077 01

  • Novartis Investigative Site

    Martin, Slovakia, 03601

  • Novartis Investigative Site

    Partizánske, Slovak Republic, 958 01

  • Novartis Investigative Site

    Prešov, Slovakia, 080 01

  • Novartis Investigative Site

    Trnava, Slovakia, 917 75

Other trials in Slovakia

Denmark7 sites

  • Novartis Investigative Site

    Aalborg, Denmark, DK-9100

  • Novartis Investigative Site

    Copenhagen NV, DK-2400

  • Novartis Investigative Site

    Hellerup, Denmark, DK-2900

  • Novartis Investigative Site

    Hvidovre, Denmark, DK-2650

  • Novartis Investigative Site

    Roskilde, Denmark, DK-4000

  • Novartis Investigative Site

    Silkeborg, Denmark, 8600

  • Novartis Investigative Site

    Sønderborg, Denmark, DK-6400

Other trials in Denmark

Greece7 sites

  • Novartis Investigative Site

    Athens, GR 11527

  • Novartis Investigative Site

    Athens, GR 12461

  • Novartis Investigative Site

    Athens, GR-106 76

  • Novartis Investigative Site

    Athens - GR, 10676

  • Novartis Investigative Site

    Larissa, Greece, 41110

  • Novartis Investigative Site

    Thessaloniki, GR 570 10

  • Novartis Investigative Site

    Thessaloniki, GR56403

Other trials in Greece

Poland7 sites

  • Novartis Investigative Site

    Bialystok, 15-010

  • Novartis Investigative Site

    Katowice, 40-752

  • Novartis Investigative Site

    Krakow, 30-067

  • Novartis Investigative Site

    Krakow, 31-159

  • Novartis Investigative Site

    Lublin, 20-637

  • Novartis Investigative Site

    Mrozy, 05-320

  • Novartis Investigative Site

    Warsaw, 01-456

Other trials in Poland

Colombia6 sites

  • Novartis Investigative Site

    Armenia

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Bogota, Cundinamarca

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Medellín, Colombia

  • Novartis Investigative Site

    Medellín

Other trials in Colombia

Mexico6 sites

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44670

  • Novartis Investigative Site

    Mexico City, Mexico City, 06726

  • Novartis Investigative Site

    Mexico City, Mexico City, 14050

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64450

  • Novartis Investigative Site

    San Luis Potosí City, San Luis Potosí, 78218

  • Novartis Investigative Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Peru6 sites

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

  • Novartis Investigative Site

    San Borja, Lima region, 41

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    San Martín de Porres, Lima region, 31

  • Novartis Investigative Site

    San Miguel, Lima region, 32

  • Novartis Investigative Site

    Santiago de Surco, Lima region, 33

Other trials in Peru

Austria5 sites

  • Novartis Investigative Site

    Feldbach, Austria, 8330

  • Novartis Investigative Site

    Grieskirchen, Austria, 4710

  • Novartis Investigative Site

    Linz, Austria, 4020

  • Novartis Investigative Site

    Salzburg, Austria, 5020

  • Novartis Investigative Site

    Thalheim bei Wels, Austria, 4600

Other trials in Austria

France5 sites

  • Novartis Investigative Site

    Bayonne, 64109

  • Novartis Investigative Site

    Beuvry, France, 62660

  • Novartis Investigative Site

    Ferolles-Attily, France, 77150

  • Novartis Investigative Site

    Montpellier, 34059

  • Novartis Investigative Site

    Paris, 75013

Other trials in France

Philippines5 sites

  • Novartis Investigative Site

    Bulacan, Philippines, 3020

  • Novartis Investigative Site

    Las Piñas, 1740

  • Novartis Investigative Site

    Manila

  • Novartis Investigative Site

    Quezon City, National Capital Region, 1109

  • Novartis Investigative Site

    Quezon City, 1100

Other trials in Philippines

South Africa5 sites

  • Novartis Investigative Site

    Durban, South Africa, 4001

  • Novartis Investigative Site

    Newtown, Johannesburg, 2193

  • Novartis Investigative Site

    Pretoria, 0181

  • Novartis Investigative Site

    Pretoria, 0184

  • Novartis Investigative Site

    Pretoria

Other trials in South Africa

Spain5 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Alicante, Alicante, 03114

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Valencia, Valencia

Other trials in Spain

Estonia3 sites

  • Novartis Investigative Site

    Tallinn, Estonia, 10138

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, Estonia, 51014

Other trials in Estonia

Finland3 sites

  • Novartis Investigative Site

    Helsinki, Finland, 00029

  • Novartis Investigative Site

    Jyväskylä, Finland, 40100

  • Novartis Investigative Site

    Turku, Finland, FIN-20100

Other trials in Finland

Ireland2 sites

  • Novartis Investigative Site

    Dublin, Ireland

  • Novartis Investigative Site

    Dublin

Other trials in Ireland

Puerto Rico1 site

  • Novartis Investigative Site

    Humacao, 00791

Other trials in Puerto Rico

About this study

Official title: A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

Being tested
QVA149, NVA237, tiotropium, Salbutamol/albuterol
Keywords
QVA149, NVA237, COPD, exacerbation, combination bronchodilator
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.

  • QVA149Drug

    QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

  • NVA237Drug

    NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

  • tiotropiumDrug

    Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

  • Salbutamol/albuterolDrug

    As needed throughout the study

Study groups in NCT01120691
Study groupRoleWhat they receive
QVA149ExperimentalQVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
Receives: Drug: QVA149; Drug: Salbutamol/albuterol
NVA237Active comparatorNVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
Receives: Drug: NVA237; Drug: Salbutamol/albuterol
open-label tiotropiumActive comparatorOpen-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
Receives: Drug: tiotropium; Drug: Salbutamol/albuterol

What is being measured

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

  1. Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.

    A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.

    Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

    Measured: 64 weeks

Secondary outcomes (12)

  1. Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.

    A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.

    Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

    Measured: 76 weeks

  2. Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period

    A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.

    Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

    Measured: 64 weeks

  3. Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics

    Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

    Measured: 64 weeks

  4. Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics

    The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.

    Measured: 64 weeks

  5. Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.

    Time to Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.

    Measured: 64 weeks

  6. Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period

    Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.

    Measured: 64 weeks

  7. Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points

    Cumulative rates were estimated using Anderson and Gill method. Chronic Obstructive Pulmonary Disease (COPD) exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

    Measured: 26, 52, 64, 76 weeks

  8. Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium

    Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.

    Spirometry measurements taken were FEV1 at -45 minutes and -15 minutes pre-dose. Three acceptable maneuvers had to be performed for each time point. The FEV1 values recorded had to be the highest values measured irrespective of whether or not they occurred on the same curve.

    The mixed model for analysis contained treatment as a fixed effect with average of the 45 minutes and 15 minutes pre dose FEV1 measurements at day 1 as the baseline measurement, FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at -14 Day) as covariates.

    Measured: 4, 12, 26, 38, 52 and 64 weeks

  9. Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium

    Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.

    Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis

    Measured: 4, 12, 26, 38, 52 and 64 weeks

  10. Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period

    The severe or less FEV1 % predicted (post bronchodilator)>=30%; very severe=> FEV1 % predicted(the post bronchodilator)<30%.Number of puffs of rescue medication taken in the previous 12 hours was recorded in patient diary in the morning and in the evening for 26 weeks.The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient.Rescue medication data recorded during the 14 day run-in was used to calculate the baseline.A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates.

    Measured: Baseline (14 day run-in), 64 weeks

  11. Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period

    A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

    Measured: Baseline (14 day run-in), 64 weeks

  12. St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment

    St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, Forced Expiratory Volume in 1 Second (FEV1) prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates. SGRQ total score is the sum of the scores from the three components; symptoms, activity and impacts.

    Measured: 12, 26, 38, 52 and 64 weeks

Timeline

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

  1. First posted11 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJul 2012
  4. Study completionJul 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120691
Sponsor's protocol ID
CQVA149A2304
Other IDs
2009-013256-69, 2009
Acronym
SPARK
Status last verified
Oct 2013
First submitted
5 May 2010
Last updated
2 Dec 2013

Publications

  • Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209. doi: 10.1016/S2213-2600(13)70052-3. Epub 2013 Apr 23.

    PubMed 24429126

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVA149, NVA237 and tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 342 sites in 28 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 5 inclusion and 37 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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 342 sites in United States, Germany, Argentina, Czechia, United Kingdom and 23 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Sep 2013). 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?

Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (time frame: 64 weeks). 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 NCT01120691, which also lists 1 linked publication.

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 2 Dec 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in