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).

  • NCT00239460
  • PHASE3
  • INTERVENTIONAL

Last updated: 2013-11-01

Purpose of  Trial

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.


This study is for people with

Pulmonary Disease, Chronic Obstructive


Interventions being studied

Tiotropium

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

Register to Save
ELIGIBILITY

Gender: ALL

Age: 40+

Healthy Volunteers: No

12 Locations
Birmingham

Attn: William C. Bailey, M.D.


Alabama, United States
Phoenix

Boehringer Ingelheim Investigational Site


Arizona, United States
Sylmar

Olive View UCLA Medical Center


California, United States
Wheat Ridge

Rocky Mountain Center for Clinical Research


Colorado, United States
Bay Pines

Respiratory Diseases (111A)


Florida, United States
Pembroke Pines

Boehringer Ingelheim Investigational Site


Florida, United States
Coeur d' Alene

Boehringer Ingelheim Investigational Site


Idaho, United States
Shreveport

LSU Health Sciences Center


Louisiana, United States
Albany

Pulmonary and Critical Care Services, PC


New York, United States
Portland

The Oregon Clinic


Oregon, United States
Charleston

Boehringer Ingelheim Investigational Site


South Carolina, United States
Houston

Boehringer Ingelheim Investigational Site


Texas, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

Back to Results New Search