Clinical trial NCT02487446: Efficacy and Safety Study of QVA149 in COPD Patients
Official title: A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 357
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: The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.


Eligibility criteria: Inclusion Criteria:

* Male or female adults aged ≥40 yrs
* Smoking history of at least 10 pack years
* Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
* Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)\< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
* Modified Medical Research Council questionnaire grade of 2 or higher

Exclusion Criteria:

* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and β2 agonists
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
timeFrame: baseline, 0 to 24 hours post-dose at week 12
Secondary outcomes:
measure: Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
timeFrame: baseline, 0 to 24 hours post-dose at week 12
measure: Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
timeFrame: baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
measure: Change From Baseline in FEV1 AUC 12-24h
timeFrame: baseline, 12 hours to 24 hours post-dose at week 12
measure: Change From Baseline in FEV1 AUC 0-12h
timeFrame: baseline, 0 to 12 hours post-dose at week 12
measure: Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
timeFrame: baseline, 15 minutes and 45 minutes pre morning dose at week 12
measure: QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
timeFrame: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
measure: QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
timeFrame: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Jasper
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Multiple Locations
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Multiple Locations
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tempe
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Fayetteville
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Rancho Mirage
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Altamonte Springs
country: United States
facility: Novartis Investigative Site
state: Florida
city: DeLand
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Kissimmee
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Orange
country: United States
facility: Novartis Investigative Site
state: Florida
city: Conyers
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Duluth
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Meridian
country: United States
facility: Novartis Investigative Site
state: Idaho
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Slidell
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Sunset
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Fridley
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Plymouth
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cornelius
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Gastonia
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Hickory
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Huntersville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Dublin
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Tipton
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Carrollton
country: United States
facility: Novartis Investigative Site
state: Texas
city: Channelview
country: United States
facility: Novartis Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lampasas
country: United States
facility: Novartis Investigative Site
state: Texas
city: McKinney
country: United States
facility: Novartis Investigative Site
state: Texas
city: New Braunfels
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
Study officials:
References:
citation: Kerwin E, Ferguson GT, Sanjar S, Goodin T, Yadao A, Fogel R, Maitra S, Sen B, Ayers T, Banerji D. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017 Dec;195(6):739-747. doi: 10.1007/s00408-017-0055-9. Epub 2017 Oct 9.