NCT00240435|CompletedPhase 3

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

A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

205.252

Study Type

interventional

Target

491

Locations

2 countries

Sites

Timeline

RegisteredOct 2005

StartedNov 2002

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

491

participants targeted

Target at P50-P75 for phase_3

Geographic Reach

2 countries

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed

Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

October 14, 2005

Last Update Submit

October 31, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

Trough FEV1 response after 12 weeks of treatment.
after 12 weeks

Secondary Outcomes (19)

Trough FEV1 response
after 1, 4 and 8 weeks
Trough FVC response
after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve and peak response
after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements at each time point
during study course of 12 weeks
Therapeutic response and percentage of responders
after 0 and 12 weeks
+14 more secondary outcomes

Interventions

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

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

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Outpatients of either sex, aged \>/= 40 years with a diagnosis of COPD (FEV1 \</= 60% predicted \[ECCS criteria\] and FEV1/FVC \</= 70%)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.