Status:
COMPLETED
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chloroflu...
Eligibility Criteria
Inclusion
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years
- Current or ex-smoker with a \>= 10 pack-year smoking history
- Use of Combivent® Metered Dose Inhaler (MDI)for \>= 1 month prior to Visit 1
- Spirometric criteria (determined at study visits):
- Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \<= 70% (Visit 1)
- Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/Forced Vital Capacity (FVC) \<= 70% (Visit 2)
Exclusion
- Clinical history of asthma
- History of thoracotomy with pulmonary resection
- History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease
- Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
- Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
- Recent history 6 months or less of Myocardial Infarction
- Unstable or life-threatening cardiac arrhythmias
- Hospitalization for Congestive Heart Failure during past year
- Malignancy for which patient is receiving chemo or radiation therapy
- Pregnant or nursing women
- Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
- Use of SPIRIVA® 3 months prior to Visit 1
- Symptomatic of prostatic hypertrophy or bladder neck obstruction
- Known narrow- angle glaucoma
- Participating in a pulmonary rehab program within 4 weeks of Visit 1
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00359788
Start Date
July 1 2006
Last Update
May 16 2014
Active Locations (31)
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1
205.325.904 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
205.325.925 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
3
205.325.909 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
4
205.325.912 Boehringer Ingelheim Investigational Site
Long Beach, California, United States