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Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01529632 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2014-02-12

Study results available
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Summary

The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

QVA149

QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily

DRUG

NVA237

NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily

DRUG

QAB149

QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily

DRUG

Placebo

Placebo capsules provided in blister packs for inhalation via SDDPI, once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Austria
  • Denmark
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT01529632 on ClinicalTrials.gov