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Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT00558285 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2012-11-30

Study results available
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Summary

An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

indacaterol/glycopyrrolate

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

DRUG

indacaterol

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

DRUG

glycopyrrolate

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

DRUG

placebo

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma AG · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • Turkey (Türkiye)

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 NCT00558285 on ClinicalTrials.gov