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

NCT ID: NCT01574651

Last Updated: 2014-05-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

934 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-04-30

Brief Summary

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

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A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QVA149 plus placebo to tiotropium and placebo to formoterol

QVA149 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.

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler

Placebo to tiotropium

Intervention Type DRUG

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 formoterol

Intervention Type DRUG

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.

Tiotropium plus Formoterol and placebo to QVA149

Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

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

Formoterol

Intervention Type DRUG

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

Placebo to QVA149

Intervention Type DRUG

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

Interventions

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QVA149

QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler

Intervention Type DRUG

Placebo to tiotropium

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

Intervention Type DRUG

Placebo to formoterol

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.

Intervention Type DRUG

Tiotropium

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

Intervention Type DRUG

Formoterol

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

Intervention Type DRUG

Placebo to QVA149

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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%

Exclusion Criteria

* 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
* Patients with concomitant pulmonary disease
* Patients requiring long term oxygen therapy (\>15 h a day)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Berlin, Germany, Germany

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Novartis Investigative Site

Berlin, Germany, Germany

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Berlin, Germany, Germany

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Dresden, Germany, Germany

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Heidelberg, Germany, Germany

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Leipzig, Germany, Germany

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Mainz, Germany, Germany

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Marburg, Germany, Germany

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Potsdam, Germany, Germany

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Teterow, Germany, Germany

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Koblenz, North Rhine-Westphalia, Germany

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Cottbus, Saxony, Germany

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Aschaffenburg, , Germany

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Augsburg, , Germany

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Bad Neustadt an der Saale, , Germany

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Bad Wörishofen, , Germany

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Bamberg, , Germany

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Bensheim, , Germany

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Bergisch Gladbach, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bonn, , Germany

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Bonn, , Germany

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Borna, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Cologne, , Germany

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Delitzsch, , Germany

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Donaustauf, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Duisburg, , Germany

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Düren, , Germany

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Düsseldorf, , Germany

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Eggenfelden, , Germany

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Eisenach, , Germany

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Erlangen, , Germany

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Eschwege, , Germany

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Essen, , Germany

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Essen, , Germany

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Euskirchen, , Germany

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Forchheim, , Germany

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Frankfurt, , Germany

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Fulda, , Germany

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Gauting, , Germany

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Geesthacht, , Germany

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Gelnhausen, , Germany

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Gelsenkirchen, , Germany

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Göttingen, , Germany

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Großhansdorf, , Germany

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Gummersbach, , Germany

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Güstrow, , Germany

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Hagen, , Germany

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Halberstadt, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hannover Münden, , Germany

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Hanover, , Germany

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Hanover, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Hettstedt, , Germany

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Hildesheim, , Germany

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Höchstadt an der Aisch, , Germany

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Kamen, , Germany

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Kamenz, , Germany

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Kassel, , Germany

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Krefeld, , Germany

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Landsberg, , Germany

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Mainz, , Germany

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Neuruppin, , Germany

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Neuss, , Germany

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Oschatz, , Germany

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Osnabrück, , Germany

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Peine, , Germany

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Schleswig, , Germany

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Singen, , Germany

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Stade, , Germany

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Teuchern, , Germany

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Ulm, , Germany

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Vöhringen, , Germany

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Wedel, , Germany

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Weyhe, , Germany

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Wiesloch, , Germany

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Wissen, , Germany

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Witten, , Germany

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Wuppertal, , Germany

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Zerbst, , Germany

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Countries

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Germany

Other Identifiers

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2011-004870-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQVA149ADE01

Identifier Type: -

Identifier Source: org_study_id

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