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QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01315249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2013-08-09

Study results available
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Summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

indacaterol and glycopyrronium (QVA149)

QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.

DRUG

Placebo to fluticasone/salmeterol

Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.

DRUG

fluticasone/salmeterol

Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.

DRUG

Placebo to indacaterol and glycopyrronium (QVA149)

Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

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
2011-03-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Belgium
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Lithuania
  • Norway
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

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 NCT01315249 on ClinicalTrials.gov