Clinical trial NCT01574651: The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149
Health related quality of life
Formoterol
Tiotropium
COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 934
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).
timeFrame: Baseline, week 26
Secondary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).
timeFrame: Baseline, week 26
measure: Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.
timeFrame: Week 26
measure: Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks
timeFrame: Week 26
measure: Percent of Participants With at Least One Exacerbation Requiring Hospitalization
timeFrame: Week 26
measure: Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period
timeFrame: Week 26
measure: Trough FEV1 at Baseline and Week 26
timeFrame: Baseline, Week 26
measure: FEV1 30 Min After the Morning Dose at Baseline and Week 26
timeFrame: Baseline, Week 26
measure: Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Koblenz
country: Germany
facility: Novartis Investigative Site
state: NRW
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Neustadt
country: Germany
facility: Novartis Investigative Site
city: Bad Woerishofen
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Bensheim
country: Germany
facility: Novartis Investigative Site
city: Bergisch Gladbach
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Borna
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Delitzsch
country: Germany
facility: Novartis Investigative Site
city: Donaustauf
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dueren
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Eggenfelden
country: Germany
facility: Novartis Investigative Site
city: Eisenach
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Eschwege
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Euskirchen
country: Germany
facility: Novartis Investigative Site
city: Forchheim
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Gauting
country: Germany
facility: Novartis Investigative Site
city: Geesthacht
country: Germany
facility: Novartis Investigative Site
city: Gelnhausen
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Grosshansdorf
country: Germany
facility: Novartis Investigative Site
city: Gummersbach
country: Germany
facility: Novartis Investigative Site
city: Göttingen
country: Germany
facility: Novartis Investigative Site
city: Güstrow
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Halberstadt
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover Münden
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Hettstedt
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Höchstadt
country: Germany
facility: Novartis Investigative Site
city: Kamenz
country: Germany
facility: Novartis Investigative Site
city: Kamen
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Krefeld
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Landsberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Luedenscheid
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Menden
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Münster
country: Germany
facility: Novartis Investigative Site
city: Münster
country: Germany
facility: Novartis Investigative Site
city: Neu Isenburg
country: Germany
facility: Novartis Investigative Site
city: Neu-Ulm
country: Germany
facility: Novartis Investigative Site
city: Neumünster
country: Germany
facility: Novartis Investigative Site
city: Neunkirchen
country: Germany
facility: Novartis Investigative Site
city: Neuruppin
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Oranienburg
country: Germany
facility: Novartis Investigative Site
city: Oschatz
country: Germany
facility: Novartis Investigative Site
city: Oschersleben
country: Germany
facility: Novartis Investigative Site
city: Osnabrück
country: Germany
facility: Novartis Investigative Site
city: Peine
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Prien a. Chiemsee
country: Germany
facility: Novartis Investigative Site
city: Radebeul
country: Germany
facility: Novartis Investigative Site
city: Rathenow
country: Germany
facility: Novartis Investigative Site
city: Ratingen
country: Germany
facility: Novartis Investigative Site
city: Reinfeld
country: Germany
facility: Novartis Investigative Site
city: Rheine
country: Germany
facility: Novartis Investigative Site
city: Roth
country: Germany
facility: Novartis Investigative Site
city: Rüdersdorf
country: Germany
facility: Novartis Investigative Site
city: Rüsselsheim
country: Germany
facility: Novartis Investigative Site
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Schleswig
country: Germany
facility: Novartis Investigative Site
city: Schwabach
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Singen
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Sonneberg
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Teterow
country: Germany
facility: Novartis Investigative Site
city: Teuchern
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Vöhringen
country: Germany
facility: Novartis Investigative Site
city: Wedel
country: Germany
facility: Novartis Investigative Site
city: Weyhe
country: Germany
facility: Novartis Investigative Site
city: Wiesloch
country: Germany
facility: Novartis Investigative Site
city: Wissen
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
city: Zerbst
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: