MedTrace Logo

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

NCT00510510 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2012-05-21

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • France
  • Germany
  • Netherlands
  • 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 NCT00510510 on ClinicalTrials.gov