Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With 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: NCT00239460
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
Study Start Date : July 2003
Primary Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Trough FEV1 at Visit 3 [ Time Frame: week 8 ]
  2. Trough FVC at Visits 3 and 4 [ Time Frame: week 8 and week 12 ]
  3. FEV1 and FVC 90 min post study drug inhalation at all visits [ Time Frame: 90 minutes post-medication ]
  4. Use of rescue medication [ Time Frame: 12 weeks ]
  5. Patient's Global Evaluation [ Time Frame: week 8 and week 12 ]
  6. Physician's Global Evaluation [ Time Frame: week 8 and week 12 ]
  7. Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4 [ Time Frame: week 8 and week 12 ]
  8. Adverse events [ Time Frame: 12 weeks ]
  9. Vital signs [ Time Frame: week 8 and week 12 ]
  10. Physical Exam [ Time Frame: week 12 ]
  11. 12-lead ECG [ Time Frame: week 8 and week 12 ]
  12. 24-hour holter ECG monitoring [ Time Frame: week 8 and week 12 ]

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

Inclusion Criteria:

  • History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
  • Smoking history greater than or equal to 10 pack years
  • Not history of clinical diagnosis of asthma and/or atopy
  • A history of thoracotomy with pulmonary resection
  • Patients requiring the use of supplemental oxygen therapy for >12 hours per day
  • Chronic use of systemic corticosteroids in an unstable daily dose
  • Patients with a recent history of myocardial infarction
  • A known hypersensitivity to anticholinergic drugs

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): NCT00239460

United States, Alabama
Attn: William C. Bailey, M.D.
Birmingham, Alabama, United States
United States, Arizona
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
Olive View UCLA Medical Center
Sylmar, California, United States
United States, Colorado
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
United States, Florida
Respiratory Diseases (111A)
Bay Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
United States, Idaho
Boehringer Ingelheim Investigational Site
Coeur d' Alene, Idaho, United States
United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States
United States, New York
Pulmonary and Critical Care Services, PC
Albany, New York, United States
United States, Oregon
The Oregon Clinic
Portland, Oregon, United States
United States, South Carolina
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00239460     History of Changes
Other Study ID Numbers: 205.284
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

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