Status:
COMPLETED
Actuation Indicator Trial in Patients With COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the performance, accuracy, and handling of the actuation indicator in patients with COPD. The actuation indicator is integrated into mouthpiece of th...
Eligibility Criteria
Inclusion
- A diagnosis of COPD based on medical history at a severity to require maintenance treatment with a bronchodilator
- Male or female patients 40 years of age or older
- A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- Must be able to use the study MDI with the mouthpiece containing actuation indicator
Exclusion
- Significant diseases other than COPD are excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last three months. Patients with treated basal cell carcinoma are allowed
- History of asthma
- Significant history active alcohol or drug abuse
- Known active tuberculosis
- Known narrow-angle glaucoma
- Current significant psychiatric disorders
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices or diaphragm with spermicide, or Norplant®)
- Known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide, HFA-134a or MDI components
- Previous participation in this trial
- Patients who are currently participating in another trial and/or who have received investigational drug within the past 30 days
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00928746
Start Date
June 1 2009
Last Update
July 2 2014
Active Locations (7)
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1
244.2507.0107 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
2
244.2507.0106 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
3
244.2507.0102 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina, United States
4
244.2507.0104 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States