Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239460
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Secondary Outcome Measures:
  • Trough FEV1 at Visit 3 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • Trough FVC at Visits 3 and 4 [ Time Frame: week 8 and week 12 ] [ Designated as safety issue: No ]
  • FEV1 and FVC 90 min post study drug inhalation at all visits [ Time Frame: 90 minutes post-medication ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation [ Time Frame: week 8 and week 12 ] [ Designated as safety issue: No ]
  • Physician's Global Evaluation [ Time Frame: week 8 and week 12 ] [ Designated as safety issue: No ]
  • Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4 [ Time Frame: week 8 and week 12 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: week 8 and week 12 ] [ Designated as safety issue: No ]
  • Physical Exam [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • 12-lead ECG [ Time Frame: week 8 and week 12 ] [ Designated as safety issue: No ]
  • 24-hour holter ECG monitoring [ Time Frame: week 8 and week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 196
Study Start Date: July 2003
Primary Completion Date: March 2004 (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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239460

Locations
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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239460     History of Changes
Other Study ID Numbers: 205.284
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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014