Overview

This trial has been completed.

Condition chronic obstructive pulmonary disease (copd)
Treatments qva149, umeclidinium/vilanterol, placebo (umeclidinium/vilanterol), placebo (qva149)
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date July 2015
End date September 2016
Trial size 356 participants
Trial identifier NCT02487446, CQVA149A2349

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
QVA149 capsules for inhalation, delivered via QVA149 SDDPI
qva149
QVA149 capsules for inhalation, delivered via QVA149 SDDPI
placebo (umeclidinium/vilanterol)
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
(Active Comparator)
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
umeclidinium/vilanterol
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
placebo (qva149)
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Primary Outcomes

Measure
To demonstrate non-inferiority of QVA149 compared to umeclidinium/vilanterol in terms of FEV1 AUC 0-24h
time frame: 12 weeks

Secondary Outcomes

Measure
To demonstrate the superiority of QVA149 compared to umeclidinium/vilanterol in terms of FEV1 AUC 0-24h
time frame: 12 weeks
To demonstrate the superiority of QVA149 compared to umeclidinium/vilanterol in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post previous morning dose)
time frame: 12 weeks
To demonstrate the superiority of QVA149 compared to umeclidinium/vilanterol in terms of FEV1 AUC 12-24h
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Novartis.