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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240435
• Other study ID #: 205.252
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: October 31, 2013
• Start date: November 2002

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

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

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

Locations

Country	Name	City	State
Canada	Boehringer Ingelheim Investigational Site	Courtice	Ontario
Canada	St. Joseph's Hospital Cardiac Research	Hamilton	Ontario
Canada	SMBD--Jewish General Hospital	Montreal	Quebec
Canada	c/o Hemodynamics Offices	Saskatoon	Saskatchewan
Canada	Centre de Recherche Clinique -CUSE	Sherbrooke	Quebec
Canada	Hopital Laval	Ste-Foy	Quebec
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Department of Respiratory Medicine	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Boehringer Ingelheim Investigational Site	Bay Pines	Florida
United States	Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	Boehringer Ingelheim Investigational Site	Downey	California
United States	Boehringer Ingelheim Investigational Site	Elizabeth City	North Carolina
United States	University of California - Los Angeles	Los Angeles	California
United States	Boehringer Ingelheim Investigational Site	New Hyde Park	New York
United States	Boehringer Ingelheim Investigational Site	Palo Alto	California
United States	Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado
United States	Boehringer Ingelheim Investigational Site	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough FEV1 response after 12 weeks of treatment.		after 12 weeks	No
Secondary	Trough FEV1 response		after 1, 4 and 8 weeks	No
Secondary	Trough FVC response		after 1, 4, 8 and 12 weeks	No
Secondary	FEV1 and FVC area under the curve and peak response		after 0, 1, 4, 8 and 12 weeks	No
Secondary	Individual FEV1 and FVC measurements at each time point		during study course of 12 weeks	No
Secondary	Therapeutic response and percentage of responders		after 0 and 12 weeks	No
Secondary	Weekly mean pre-dose morning and evening PEFR		during study course of 12 weeks	No
Secondary	Number of occasions of rescue therapy used per day (PRN salbutamol)		during study course of 12 weeks	No
Secondary	COPD symptom scores		during 15 weeks	No
Secondary	Physician's Global Evaluation		during 15 weeks	No
Secondary	Number of patients with at least one exacerbation of COPD		15 weeks	No
Secondary	time to first exacerbation		15 weeks	No
Secondary	number of exacerbations		15 weeks	No
Secondary	number of exacerbation days		15 weeks	No
Secondary	Patient satisfaction and preference		12 weeks	No
Secondary	All adverse events		during 15 weeks, follow-up period included	No
Secondary	Pulse rate and blood pressure for the first three hours following dosing		after 0, 1, 4, 8 and 12 weeks	No
Secondary	Routine blood chemistry, haematology and urinalysis		after 12 weeks	No
Secondary	12-lead ECG		after 12 weeks	No
Secondary	Physical examination		after 12 weeks	No

External Links

•   Link
•   Link
•   Link