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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239473
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 response [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1 response [ Time Frame: after 1, 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Trough FVC response [ Time Frame: after 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • FEV1 and FVC area under the curve (AUC)0-6h and peak response [ Time Frame: after 0, 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 and FVC measurements [ Time Frame: during 12 weeks ] [ Designated as safety issue: No ]
  • Onset and duration of therapeutic response and percentage of responders [ Time Frame: after 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Evaluation [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Number of patients with at least one exacerbation of COPD [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Time to first exacerbation [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Number of exacerbations and exacerbation days [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 429
Study Start Date: November 2002
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239473

Locations
Germany
MEDARS GmbH
Berlin, Germany
Boehringer Ingelheim Investigational Site
Berlin, Germany
Boehringer Ingelheim Investigational Site
Bonn, Germany
Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
Inamed Research GmbH & Co. KG
Gauting, Germany
Pneumologisches Forschungsinstitut GmbH
Großhansdorf, Germany
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg, Germany
Boehringer Ingelheim Investigational Site
Hannover, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
ClinPharm International GmbH & Co. KG
Leipzig, Germany
Neurologische Klinik der Otto-von-Guericke-Universität
Magdeburg, Germany
Johannes-Gutenberg-Universität Mainz
Mainz, Germany
Boehringer Ingelheim Investigational Site
Minden, Germany
Medizinische Klinik III
Moers, Germany
Boehringer Ingelheim Investigational Site
München, Germany
Abt. Lungen- und Bronchialheilkunde
Schmallenberg, Germany
Boehringer Ingelheim Investigational Site
Steinfurt, Germany
Italy
Ospedale Generale Provinciale Mazzoni
Ascoli Piceno, Italy
Dip. di Medicina Interna e Medicina Specialistica
Catania, Italy
U. O. di Fisiopatologia Respiratoria
Ferrara, Italy
Ospedale S. Martino
Genova, Italy
U. O. di Pneumologia e Servizio di Fisiopatologia Resp.
Milano, Italy
IRCCS Policlinico San Matteo
Pavia, Italy
U. O. C di Pneumologia
Roma, Italy
Ospedale Silvestrini
San Sisto (pg), Italy
U. O. di Pneumologia
Trieste, Italy
South Africa
Hydromed Hospital
Bloemfontein, South Africa
UCT Lung Institute
Cape Town, South Africa
1 Military Hospital
Pretoria, South Africa
Tygerberg Hospital
Tygerberg, South Africa
Switzerland
Universitätskliniken Basel
Basel, Switzerland
Ospedale San Giovanni
Bellinzona, Switzerland
Boehringer Ingelheim Investigational Site
Davos, Switzerland
Boehringer Ingelheim Investigational Site
Laufen, Switzerland
Boehringer Ingelheim Investigational Site
Locarno, Switzerland
Ospedale Regionale
Lugano, Switzerland
Boehringer Ingelheim Investigational Site
Münchenstein, Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239473     History of Changes
Other Study ID Numbers: 205.251
Study First Received: October 14, 2005
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Ipratropium
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics

ClinicalTrials.gov processed this record on April 16, 2014