Clinical trial NCT01490125: The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Dyspnea
QVA149
tiotropium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 247
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Detailed description: This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe stable chronic obstructive pulmonary disease
* Smoking history of 10 pack years
* Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%
* Patients must be able to use computer mouse and display
* mMRC grade\>2

Exclusion Criteria:

* 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: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium
timeFrame: Baseline and 6 weeks
measure: Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
timeFrame: 5min-4hr at day 1 and week 6 post-dose
measure: Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
timeFrame: 5min-4hr at day 1 and week 6 post-dose
measure: Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Gilly
country: Belgium
facility: Novartis Investigative Site
city: Jambes
country: Belgium
facility: Novartis Investigative Site
city: Jette
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Oostende
country: Belgium
facility: Novartis Investigative Site
city: Wavre
country: Belgium
facility: Novartis Investigative Site
city: Burlington
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mississauga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Laval
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Mirabel
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Charles-Borromée
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Aschaffenburg
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: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hannover
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: Mainz
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Rheine
country: Germany
facility: Novartis Investigative Site
city: Rüdersdorf
country: Germany
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Mérida
country: Spain
facility: Novartis Investigative Site
state: Badajoz
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Ponferrada
country: Spain
facility: Novartis Investigative Site
state: Leon
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
state: Manchester
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Mahler DA, Decramer M, D'Urzo A, Worth H, White T, Alagappan VK, Chen H, Gallagher N, Kulich K, Banerji D. Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study. Eur Respir J. 2014 Jun;43(6):1599-609. doi: 10.1183/09031936.00124013. Epub 2013 Oct 31.