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12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

NCT00239473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2013-11-01

No results posted yet for this study

Summary

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

DEVICE

10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim Study Coordinator · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2003-12-31

Countries

  • Germany
  • Italy
  • South Africa
  • Switzerland

Study Locations

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Entities

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 NCT00239473 on ClinicalTrials.gov