Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, Two-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.
Verified date | March 2018 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 355 |
Est. completion date | September 6, 2016 |
Est. primary completion date | September 6, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 ß2 agonists - Other protocol-defined inclusion/exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
United States | Novartis Investigative Site | Amarillo | Texas |
United States | Novartis Investigative Site | Anaheim | California |
United States | Novartis Investigative Site | Anderson | South Carolina |
United States | Novartis Investigative Site | Boerne | Texas |
United States | Novartis Investigative Site | Charleston | South Carolina |
United States | Novartis Investigative Site | Charleston | South Carolina |
United States | Novartis Investigative Site | Chiefland | Florida |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Clearwater | Florida |
United States | Novartis Investigative Site | Easley | South Carolina |
United States | Novartis Investigative Site | El Paso | Texas |
United States | Novartis Investigative Site | Escondido | California |
United States | Novartis Investigative Site | Eugene | Oregon |
United States | Novartis Investigative Site | Florence | Kentucky |
United States | Novartis Investigative Site | Fort Mill | South Carolina |
United States | Novartis Investigative Site | Fort Worth | Texas |
United States | Novartis Investigative Site | Gaffney | South Carolina |
United States | Novartis Investigative Site | Gainesville | Florida |
United States | Novartis Investigative Site | Gastonia | North Carolina |
United States | Novartis Investigative Site | Greenfield | Wisconsin |
United States | Novartis Investigative Site | Greenville | South Carolina |
United States | Novartis Investigative Site | Kingwood | Texas |
United States | Novartis Investigative Site | Lincoln | Nebraska |
United States | Novartis Investigative Site | Livonia | Michigan |
United States | Novartis Investigative Site | Miami | Florida |
United States | Novartis Investigative Site | Miami | Florida |
United States | Novartis Investigative Site | Monroe | North Carolina |
United States | Novartis Investigative Site | Mount Pleasant | South Carolina |
United States | Novartis Investigative Site | New Bern | North Carolina |
United States | Novartis Investigative Site | North Dartmouth | Massachusetts |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Owensboro | Kentucky |
United States | Novartis Investigative Site | Plano | Texas |
United States | Novartis Investigative Site | Pottstown | Pennsylvania |
United States | Novartis Investigative Site | Raleigh | North Carolina |
United States | Novartis Investigative Site | Richmond | Virginia |
United States | Novartis Investigative Site | Riverside | California |
United States | Novartis Investigative Site | Rock Hill | South Carolina |
United States | Novartis Investigative Site | Saint Charles | Missouri |
United States | Novartis Investigative Site | Saint Louis | Missouri |
United States | Novartis Investigative Site | San Antonio | Texas |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | Seneca | South Carolina |
United States | Novartis Investigative Site | Shelby | North Carolina |
United States | Novartis Investigative Site | Simpsonville | South Carolina |
United States | Novartis Investigative Site | Skillman | New Jersey |
United States | Novartis Investigative Site | Spartanburg | South Carolina |
United States | Novartis Investigative Site | Union | South Carolina |
United States | Novartis Investigative Site | Wilmington | North Carolina |
United States | Novartis Investigative Site | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement. | baseline, 0 to 24 hours post-dose at week 12 | |
Secondary | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement. | baseline, 0 to 24 hours post-dose at week 12 | |
Secondary | Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment. | baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12 | |
Secondary | Change From Baseline in FEV1 AUC 12-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h). | baseline, 12 hours to 24 hours post-dose at week 12 | |
Secondary | Change From Baseline in FEV1 AUC 0-12h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h). | baseline, 0 to 12 hours post-dose at week 12 | |
Secondary | Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h. | baseline, 12 weeks | |
Secondary | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment. | baseline, 12 weeks | |
Secondary | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | FEV1 was measured with spirometry conducted according to internationally accepted standards. | 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) | |
Secondary | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | FEV1 was measured with spirometry conducted according to internationally accepted standards. | Day 1 (5min, 15min, 30 min, 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) |
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