Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239447
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium Device: HandiHaler Device: Respimat SMI Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of 4-week Treatment Periods 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, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : November 2002
Actual Primary Completion Date : April 2004
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Primary Outcome Measures :
  1. Trough FEV1 response determined at the end of each 4-week period of randomised treatment. [ Time Frame: at the end of each 4-week period ]

Secondary Outcome Measures :
  1. Tiotropium plasma concentration data and urinary excretion data [ Time Frame: at the end of each 4-week period ]
  2. Trough forced vital capacity (FVC) response [ Time Frame: after 4 weeks ]
  3. Peak response (FEV1 and FVC) [ Time Frame: within 3 hours after first dose, after 4 weeks ]
  4. FEV1 AUC 0-12h and FVC AUC 0-12h response [ Time Frame: after 4 weeks ]
  5. FEV1 AUC 0-3h and FVC AUC 0-3h response [ Time Frame: after the first dose, after 4 weeks ]
  6. Individual FEV1and FVC measurements [ Time Frame: during study course of 28 weeks ]
  7. pre-dose morning and evening peak expiratory flow rate (PEFR) [ Time Frame: during study course of 28 weeks ]
  8. Number of occasions of rescue therapy used [ Time Frame: during study course of 28 weeks ]
  9. Median time to onset of therapeutic response after first dose (FEV1) [ Time Frame: after first dose and after 4 weeks ]
  10. Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks [ Time Frame: up to 28 weeks ]

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239447

United States, Arkansas
Division of Pulmonary and Critical Care Medicine
Little Rock, Arkansas, United States, 72205
United States, California
Boehringer Ingelheim Investigational Site
San Diego, California, United States, 92120
San Jose Clinical Research
San Jose, California, United States, 95128
Boehringer Ingelheim Investigational Site
Stockton, California, United States, 95207
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206-2762
United States, Louisiana
LSU MC-Sheveport
Shreveport, Louisiana, United States, 71103
United States, Minnesota
Minisota Lung Center
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Washington
Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States, 98405
Canada, Quebec
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, Canada, H2X 2P4
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar Identifier: NCT00239447     History of Changes
Other Study ID Numbers: 205.249
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
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