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

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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 response after 12 weeks of treatment. [ Time Frame: after 12 weeks ]

Secondary Outcome Measures:
  • Trough FEV1 response [ Time Frame: after 1, 4 and 8 weeks ]
  • Trough FVC response [ Time Frame: after 1, 4, 8 and 12 weeks ]
  • FEV1 and FVC area under the curve and peak response [ Time Frame: after 0, 1, 4, 8 and 12 weeks ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: during study course of 12 weeks ]
  • Therapeutic response and percentage of responders [ Time Frame: after 0 and 12 weeks ]
  • Weekly mean pre-dose morning and evening PEFR [ Time Frame: during study course of 12 weeks ]
  • Number of occasions of rescue therapy used per day (PRN salbutamol) [ Time Frame: during study course of 12 weeks ]
  • COPD symptom scores [ Time Frame: during 15 weeks ]
  • Physician's Global Evaluation [ Time Frame: during 15 weeks ]
  • Number of patients with at least one exacerbation of COPD [ Time Frame: 15 weeks ]
  • time to first exacerbation [ Time Frame: 15 weeks ]
  • number of exacerbations [ Time Frame: 15 weeks ]
  • number of exacerbation days [ Time Frame: 15 weeks ]
  • Patient satisfaction and preference [ Time Frame: 12 weeks ]
  • All adverse events [ Time Frame: during 15 weeks, follow-up period included ]
  • Pulse rate and blood pressure for the first three hours following dosing [ Time Frame: after 0, 1, 4, 8 and 12 weeks ]
  • Routine blood chemistry, haematology and urinalysis [ Time Frame: after 12 weeks ]
  • 12-lead ECG [ Time Frame: after 12 weeks ]
  • Physical examination [ Time Frame: after 12 weeks ]

Estimated Enrollment: 491
Study Start Date: November 2002
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00240435

  Hide Study Locations
United States, Alabama
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, California
Boehringer Ingelheim Investigational Site
Downey, California, United States
University of California - Los Angeles
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Palo Alto, California, United States
United States, Colorado
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
United States, Florida
Boehringer Ingelheim Investigational Site
Bay Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
United States, Maryland
Boehringer Ingelheim Investigational Site
Wheaton, Maryland, United States
United States, Missouri
Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, New York
Boehringer Ingelheim Investigational Site
New Hyde Park, New York, United States
United States, North Carolina
Boehringer Ingelheim Investigational Site
Elizabeth City, North Carolina, United States
United States, South Carolina
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
Canada, British Columbia
Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Canada, Ontario
Boehringer Ingelheim Investigational Site
Courtice, Ontario, Canada
St. Joseph's Hospital Cardiac Research
Hamilton, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Department of Respiratory Medicine
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Canada, Quebec
SMBD--Jewish General Hospital
Montreal, Quebec, Canada
Centre de Recherche Clinique -CUSE
Sherbrooke, Quebec, Canada
Hopital Laval
Ste-Foy, Quebec, Canada
Canada, Saskatchewan
c/o Hemodynamics Offices
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information Identifier: NCT00240435     History of Changes
Other Study ID Numbers: 205.252
Study First Received: October 14, 2005
Last Updated: October 31, 2013

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Pharmaceutical Solutions
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017