AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 3QUANTIFYNCT01574651

The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing QVA149, Tiotropium and Formoterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 144 sites in Germany.

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 will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
QVA149, Tiotropium and Formoterol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
934 participants
Where
144 sitesGermany
Study dates
May 2012to Apr 2013
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 yrs
  • Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)
  • Smoking history of at least 10 pack years
  • Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Who cannot join

  • Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
  • Patients with a history of long QT syndrome
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
  • Patients with any history of asthma
  • Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
Show all 9Show fewer
  • Patients with concomitant pulmonary disease
  • Patients requiring long term oxygen therapy (>15 h a day)
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

144 sites in 1 country.

144 sites in 1 country

Germany144 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Augsburg, 86156

  • Novartis Investigative Site

    Bad Neustadt an der Saale, 97616

  • Novartis Investigative Site

    Bad Wörishofen, 86825

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Bensheim, 64625

  • Novartis Investigative Site

    Bergisch Gladbach, 51429

  • Novartis Investigative Site

    Berlin, Germany, 10969

  • Novartis Investigative Site

    Berlin, Germany, 12099

  • Novartis Investigative Site

    Berlin, Germany, 14050

  • Novartis Investigative Site

    Berlin, 10115

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 10717

  • Novartis Investigative Site

    Berlin, 10789

  • Novartis Investigative Site

    Berlin, 12043

  • Novartis Investigative Site

    Berlin, 12165

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 12687

  • Novartis Investigative Site

    Berlin, 13057

  • Novartis Investigative Site

    Berlin, 13086

  • Novartis Investigative Site

    Berlin, 13156

  • Novartis Investigative Site

    Berlin, 13465

  • Novartis Investigative Site

    Berlin, 13507

  • Novartis Investigative Site

    Berlin, 14059

  • Novartis Investigative Site

    Bielefeld, 33617

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Bonn, 53123

  • Novartis Investigative Site

    Borna, 04552

  • Novartis Investigative Site

    Chemnitz, 09130

  • Novartis Investigative Site

    Cologne, 51069

  • Novartis Investigative Site

    Cologne, 51605

  • Novartis Investigative Site

    Cottbus, Saxony, 03050

  • Novartis Investigative Site

    Delitzsch, 04509

  • Novartis Investigative Site

    Donaustauf, 93093

  • Novartis Investigative Site

    Dortmund, 44135

  • Novartis Investigative Site

    Dresden, Germany, 01307

  • Novartis Investigative Site

    Dresden, 01069

  • Novartis Investigative Site

    Duisburg, 47057

  • Novartis Investigative Site

    Düren, 52349

  • Novartis Investigative Site

    Düsseldorf, 40489

  • Novartis Investigative Site

    Eggenfelden, 84307

  • Novartis Investigative Site

    Eisenach, 99817

  • Novartis Investigative Site

    Erlangen, 91052

  • Novartis Investigative Site

    Eschwege, 37269

  • Novartis Investigative Site

    Essen, 45138

  • Novartis Investigative Site

    Essen, 45276

  • Novartis Investigative Site

    Euskirchen, 53879

  • Novartis Investigative Site

    Forchheim, 91301

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Fulda, 36039

  • Novartis Investigative Site

    Gauting, 82131

  • Novartis Investigative Site

    Geesthacht, 22502

  • Novartis Investigative Site

    Gelnhausen, 63571

  • Novartis Investigative Site

    Gelsenkirchen, 45879

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Großhansdorf, 22947

  • Novartis Investigative Site

    Gummersbach, 51643

  • Novartis Investigative Site

    Güstrow, 18273

  • Novartis Investigative Site

    Hagen, 59065

  • Novartis Investigative Site

    Halberstadt, 38820

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 20357

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hamburg, 22527

  • Novartis Investigative Site

    Hannover Münden, 34346

  • Novartis Investigative Site

    Hanover, 30163

  • Novartis Investigative Site

    Hanover, 30317

  • Novartis Investigative Site

    Hanover, 30419

  • Novartis Investigative Site

    Heidelberg, Germany, 69117

  • Novartis Investigative Site

    Heidelberg, 69115

  • Novartis Investigative Site

    Hettstedt, 06333

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Höchstadt an der Aisch, 91315

  • Novartis Investigative Site

    Kamen, 59174

  • Novartis Investigative Site

    Kamenz, 01917

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Koblenz, North Rhine-Westphalia, 56068

  • Novartis Investigative Site

    Krefeld, 47798

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, Germany, 04207

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Leipzig, 04357

  • Novartis Investigative Site

    Lübeck, 23558

  • Novartis Investigative Site

    Lüdenscheid, 58507

  • Novartis Investigative Site

    Mainz, Germany, 55131

  • Novartis Investigative Site

    Mainz, 55116

  • Novartis Investigative Site

    Mannheim, 68165

  • Novartis Investigative Site

    Marburg, Germany, 35037

  • Novartis Investigative Site

    Marburg, 35037

  • Novartis Investigative Site

    Menden, 58706

  • Novartis Investigative Site

    Minden, 32423

  • Novartis Investigative Site

    München, 80335

  • Novartis Investigative Site

    München, 80539

  • Novartis Investigative Site

    München, 81677

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Münster, 48147

  • Novartis Investigative Site

    Neu-Isenburg, 63263

  • Novartis Investigative Site

    Neu-Ulm, 89231

  • Novartis Investigative Site

    Neumünster, 24534

  • Novartis Investigative Site

    Neunkirchen, 66539

  • Novartis Investigative Site

    Neuruppin, 16816

  • Novartis Investigative Site

    Neuss, 41462

  • Novartis Investigative Site

    Oranienburg, 16515

  • Novartis Investigative Site

    Oschatz, 04758

  • Novartis Investigative Site

    Oschersleben, 39387

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Peine, 31224

  • Novartis Investigative Site

    Potsdam, Germany, 14467

  • Novartis Investigative Site

    Potsdam, 14469

  • Novartis Investigative Site

    Potsdam, 14478

  • Novartis Investigative Site

    Prien A. Chiemsee, 83209

  • Novartis Investigative Site

    Radebeul, 01445

  • Novartis Investigative Site

    Rathenow, 14712

  • Novartis Investigative Site

    Ratingen, 40878

  • Novartis Investigative Site

    Reinfeld, 23858

  • Novartis Investigative Site

    Rheine, 48431

  • Novartis Investigative Site

    Roth, 91154

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Rüsselsheim am Main, 65428

  • Novartis Investigative Site

    Saarbrücken, 66111

  • Novartis Investigative Site

    Saarlouis, 66740

  • Novartis Investigative Site

    Schleswig, 24837

  • Novartis Investigative Site

    Schwabach, 91126

  • Novartis Investigative Site

    Siegen, 57072

  • Novartis Investigative Site

    Singen, 76224

  • Novartis Investigative Site

    Solingen, 42651

  • Novartis Investigative Site

    Solingen, 42665

  • Novartis Investigative Site

    Sonneberg, 96515

  • Novartis Investigative Site

    Stade, 21680

  • Novartis Investigative Site

    Teterow, Germany, 17166

  • Novartis Investigative Site

    Teuchern, 06682

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Vöhringen, 89269

  • Novartis Investigative Site

    Wedel, 22880

  • Novartis Investigative Site

    Weyhe, 28844

  • Novartis Investigative Site

    Wiesloch, 69168

  • Novartis Investigative Site

    Wissen, 57537

  • Novartis Investigative Site

    Witten, 58452

  • Novartis Investigative Site

    Wuppertal, 42117

  • Novartis Investigative Site

    Zerbst, 39261

Other trials in Germany

About this study

Official title: A 26-week Treatment, Multicenter, Randomized, Parallel Group, Blinded Study to Assess the Efficacy and Safety of QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Using Tiotropium Plus Formoterol as Control

This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

Being tested
QVA149, Placebo to tiotropium, Placebo to formoterol, Tiotropium, Formoterol
Keywords
QVA149, Health related quality of life, Formoterol, Tiotropium, COPD
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 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler

  • Placebo to tiotropiumDrug

    Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules

  • Placebo to formoterolDrug

    Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.

  • TiotropiumDrug

    Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.

  • FormoterolDrug

    Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.

  • Placebo to QVA149Drug

    Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules

Study groups in NCT01574651
Study groupRoleWhat they receive
QVA149 plus placebo to tiotropium and placebo to formoterolExperimentalQVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
Receives: Drug: QVA149; Drug: Placebo to tiotropium; Drug: Placebo to formoterol
Tiotropium plus Formoterol and placebo to QVA149Active comparatorTiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
Receives: Drug: Tiotropium; Drug: Formoterol; Drug: Placebo to QVA149

What is being measured

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

  1. St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).

    SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.

    Measured: Baseline, week 26

Secondary outcomes (8)

  1. St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).

    SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment

    Measured: Baseline, week 26

  2. Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.

    Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)

    Measured: Week 26

  3. Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks

    The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment

    Measured: Week 26

  4. Percent of Participants With at Least One Exacerbation Requiring Hospitalization

    The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.

    Measured: Week 26

  5. Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period

    The number of participants with at least one moderate or severe COPD exacerbation. 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 hospitalizations were required.

    Measured: Week 26

  6. Trough FEV1 at Baseline and Week 26

    Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.

    Measured: Baseline, Week 26

  7. FEV1 30 Min After the Morning Dose at Baseline and Week 26

    FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.

    Measured: Baseline, Week 26

  8. Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C

    Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.

    Measured: Baseline, Week 26

Timeline

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

  1. First posted10 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

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
Double blind
Who is masked
Participant, Investigator
Enrolment
934 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01574651
Sponsor's protocol ID
CQVA149ADE01
Other IDs
2011-004870-26
Acronym
QUANTIFY
Status last verified
May 2014
First submitted
6 Apr 2012
Last updated
22 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVA149, Tiotropium and Formoterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 144 sites in Germany.

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 4 inclusion and 9 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in Germany. 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 29 Apr 2014). 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?

St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis). (time frame: Baseline, week 26). 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 NCT01574651.

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 22 May 2014.

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