Status:
COMPLETED
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 tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in...
Eligibility Criteria
Inclusion
- Diagnosis of COPD
- Age: \>= 40 years
- Current or ex-smoker with a \>= 10 pack-year smoking history
- Use of Combivent® MDI for \>= 1 month prior to Visit 1 Spirometric criteria (determined at study visits):
- Post-bronchodilator FEV1 \<= 70% (Visit 1)
- Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/FVC \<= 70% (Visit 2)
Exclusion
- Clinical history of asthma
- History of thoracotomy with pulmonary resection
- History of CF, alpha 1 antitrypsin deficiency or interstitial lung disease
- Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain from using oxygen during PFTs
- Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
- Recent history 6 months or less of MI
- Unstable or life-threatening cardiac arrhythmias
- Hospitalization for CHF 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 :
October 4 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT00388882
Start Date
October 4 2006
Last Update
December 1 2023
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
205.346.107 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
2
205.346.104 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
3
205.346.108 Boehringer Ingelheim Investigational Site
Sepulveda, California, United States
4
205.346.101 Boehringer Ingelheim Investigational Site
Torrance, California, United States