Clinical trial NCT00239460: Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 196
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Trough FEV1 after 12 weeks of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Trough FEV1 at Visit 3
timeFrame: week 8
measure: Trough FVC at Visits 3 and 4
timeFrame: week 8 and week 12
measure: FEV1 and FVC 90 min post study drug inhalation at all visits
timeFrame: 90 minutes post-medication
measure: Use of rescue medication
timeFrame: 12 weeks
measure: Patient's Global Evaluation
timeFrame: week 8 and week 12
measure: Physician's Global Evaluation
timeFrame: week 8 and week 12
measure: Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4
timeFrame: week 8 and week 12
measure: Adverse events
timeFrame: 12 weeks
measure: Vital signs
timeFrame: week 8 and week 12
measure: Physical Exam
timeFrame: week 12
measure: 12-lead ECG
timeFrame: week 8 and week 12
measure: 24-hour holter ECG monitoring
timeFrame: week 8 and week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Attn: William C. Bailey, M.D.
state: Alabama
city: Phoenix
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Bay Pines
country: United States
facility: Respiratory Diseases (111A)
state: Florida
city: Pembroke Pines
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Coeur d' Alene
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Albany
country: United States
facility: Pulmonary and Critical Care Services, PC
state: New York
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Charleston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
citation: Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.