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A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01202188 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2144

Last updated 2013-09-09

Study results available
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Summary

The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

indacaterol and glycopyrronium (QVA149)

Capsules for inhalation delivered via SDDPI.

DRUG

glycopyrronium (NVA237)

Capsules for inhalation delivered via SDDPI.

DRUG

indacaterol (QAB149)

Capsules for inhalation delivered via SDDPI.

DRUG

tiotropium

Capsules for inhalation delivered via HandiHaler® device.

DRUG

placebo

Placebo to match capsules for inhalation delivered via SDDPI.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • France
  • Germany
  • Guatemala
  • Hungary
  • Japan
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01202188 on ClinicalTrials.gov