NCT00558285

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)

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-11-14
• Last updated: 2012-11-30
• Results posted: 2012-11-22

Locations

40 sites across 8 countries: Australia, Belgium, Canada, France, Germany, Italy, Spain, Turkey (Türkiye)