Clinical trial NCT00240435: 12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 491
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Trough FEV1 response after 12 weeks of treatment.
timeFrame: after 12 weeks
Secondary outcomes:
measure: Trough FEV1 response
timeFrame: after 1, 4 and 8 weeks
measure: Trough FVC response
timeFrame: after 1, 4, 8 and 12 weeks
measure: FEV1 and FVC area under the curve and peak response
timeFrame: after 0, 1, 4, 8 and 12 weeks
measure: Individual FEV1 and FVC measurements at each time point
timeFrame: during study course of 12 weeks
measure: Therapeutic response and percentage of responders
timeFrame: after 0 and 12 weeks
measure: Weekly mean pre-dose morning and evening PEFR
timeFrame: during study course of 12 weeks
measure: Number of occasions of rescue therapy used per day (PRN salbutamol)
timeFrame: during study course of 12 weeks
measure: COPD symptom scores
timeFrame: during 15 weeks
measure: Physician's Global Evaluation
timeFrame: during 15 weeks
measure: Number of patients with at least one exacerbation of COPD
timeFrame: 15 weeks
measure: time to first exacerbation
timeFrame: 15 weeks
measure: number of exacerbations
timeFrame: 15 weeks
measure: number of exacerbation days
timeFrame: 15 weeks
measure: Patient satisfaction and preference
timeFrame: 12 weeks
measure: All adverse events
timeFrame: during 15 weeks, follow-up period included
measure: Pulse rate and blood pressure for the first three hours following dosing
timeFrame: after 0, 1, 4, 8 and 12 weeks
measure: Routine blood chemistry, haematology and urinalysis
timeFrame: after 12 weeks
measure: 12-lead ECG
timeFrame: after 12 weeks
measure: Physical examination
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Downey
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Palo Alto
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Bay Pines
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Wheaton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Maryland
city: St. Louis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Missouri
city: New Hyde Park
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Elizabeth City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Vancouver
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Courtice
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital Cardiac Research
state: Ontario
city: Toronto
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Department of Respiratory Medicine
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: SMBD--Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de Recherche Clinique -CUSE
state: Quebec
city: Ste-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: Saskatoon
country: Canada
facility: c/o Hemodynamics Offices
state: Saskatchewan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: