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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239460
• Other study ID #: 205.284
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: October 31, 2013
• Start date: July 2003

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough FEV1 after 12 weeks of treatment		12 weeks	No
Secondary	Trough FEV1 at Visit 3		week 8	No
Secondary	Trough FVC at Visits 3 and 4		week 8 and week 12	No
Secondary	FEV1 and FVC 90 min post study drug inhalation at all visits		90 minutes post-medication	No
Secondary	Use of rescue medication		12 weeks	No
Secondary	Patient's Global Evaluation		week 8 and week 12	No
Secondary	Physician's Global Evaluation		week 8 and week 12	No
Secondary	Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4		week 8 and week 12	No
Secondary	Adverse events		12 weeks	No
Secondary	Vital signs		week 8 and week 12	No
Secondary	Physical Exam		week 12	No
Secondary	12-lead ECG		week 8 and week 12	No
Secondary	24-hour holter ECG monitoring		week 8 and week 12	No

External Links

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