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Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.

NCT02487498 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2018-04-02

Study results available
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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.

Conditions

Interventions

DRUG

QVA149

QVA149 capsules for inhalation, delivered via QVA149 SDDPI

DRUG

Umeclidinium/vilanterol

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

DRUG

Placebo (umeclidinium/vilanterol )

Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

DRUG

Placebo (QVA149)

Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-27
Primary Completion
2016-09-06
Completion
2016-09-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487498 on ClinicalTrials.gov