Clinical trial NCT00239473: 12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
Official title: A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 429
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
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 (AUC)0-6h and peak response
timeFrame: after 0, 1, 4, 8 and 12 weeks
measure: Individual FEV1 and FVC measurements
timeFrame: during 12 weeks
measure: Onset and duration of therapeutic response and percentage of responders
timeFrame: after 0 and 12 weeks
measure: Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
timeFrame: up to 12 weeks
measure: Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
timeFrame: up to 12 weeks
measure: COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
timeFrame: up to 15 weeks
measure: Physician's Global Evaluation
timeFrame: up to 15 weeks
measure: Number of patients with at least one exacerbation of COPD
timeFrame: up to 15 weeks
measure: Time to first exacerbation
timeFrame: up to 15 weeks
measure: Number of exacerbations and exacerbation days
timeFrame: up to 15 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: MEDARS GmbH
city: Bonn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gauting
country: Germany
facility: Inamed Research GmbH & Co. KG
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut GmbH
city: Hamburg
country: Germany
facility: Pneumologisches Forschungsinstitut GmbH am Krankenhaus
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: ClinPharm International GmbH & Co. KG
city: Magdeburg
country: Germany
facility: Neurologische Klinik der Otto-von-Guericke-Universität
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universität Mainz
city: Minden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Moers
country: Germany
facility: Medizinische Klinik III
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schmallenberg
country: Germany
facility: Abt. Lungen- und Bronchialheilkunde
city: Steinfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ascoli Piceno
country: Italy
facility: Ospedale Generale Provinciale Mazzoni
city: Catania
country: Italy
facility: Dip. di Medicina Interna e Medicina Specialistica
city: Ferrara
country: Italy
facility: U. O. di Fisiopatologia Respiratoria
city: Genova
country: Italy
facility: Ospedale S. Martino
city: Milano
country: Italy
facility: U. O. di Pneumologia e Servizio di Fisiopatologia Resp.
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: U. O. C di Pneumologia
city: San Sisto (pg)
country: Italy
facility: Ospedale Silvestrini
city: Trieste
country: Italy
facility: U. O. di Pneumologia
city: Bloemfontein
country: South Africa
facility: Hydromed Hospital
city: Cape Town
country: South Africa
facility: UCT Lung Institute
city: Pretoria
country: South Africa
facility: 1 Military Hospital
city: Tygerberg
country: South Africa
facility: Tygerberg Hospital
city: Basel
country: Switzerland
facility: Universitätskliniken Basel
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
city: Davos
country: Switzerland
facility: Boehringer Ingelheim Investigational Site
city: Laufen
country: Switzerland
facility: Boehringer Ingelheim Investigational Site
city: Locarno
country: Switzerland
facility: Boehringer Ingelheim Investigational Site
city: Lugano
country: Switzerland
facility: Ospedale Regionale
city: Münchenstein
country: Switzerland
facility: Boehringer Ingelheim Investigational Site
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: