NCT00510510

Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	NVA237 100 µg	Dry powder inhalation once a day for up to 28 days
DRUG	Placebo	Placebo to NVA237 dry powder inhalation once a day for up to 28 days
DRUG	NVA237 200 µg	Dry powder inhalation once a day for up to 28 days

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-08-02
• Last updated: 2012-05-21
• Results posted: 2011-01-21

Locations

21 sites across 6 countries: United States, France, Germany, Netherlands, Spain, Turkey (Türkiye)