Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
Status: | Completed |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 12/30/2017 |
Start Date: | October 2006 |
A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI
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 COPD patients currently prescribed Combivent® MDI.
tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2
actuations qid in COPD patients currently prescribed Combivent® MDI.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
11
sites
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