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The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01490125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2013-12-24

Study results available
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Summary

This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Conditions

Interventions

DRUG

QVA149

QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI

DRUG

Tiotropium

Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

DRUG

Placebo to QVA149

Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI

DRUG

Placebo to tiotropium

Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

DRUG

Salbutamol/albuterol

salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Belgium
  • Canada
  • Germany
  • Spain
  • United Kingdom

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 NCT01490125 on ClinicalTrials.gov