Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: tiotropium
* Drug: ipratropium bromide / albuterol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tiotropium|nan|
|Drug: ipratropium bromide / albuterol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough FEV1 |  | after 12 weeks of treatment | 
| FEV1 AUC0-6 hours |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak FEV1 |  | 12 weeks | 
| Peak FEV1 |  | after first dose and 6 week | 
| FEV1 AUC0-6 hours |  | after first dose and 6 weeks | 
| Trough FEV1 |  | at 6 weeks | 
| Peak FVC at all clinic visits |  | 12 weeks | 
| AUC0-6 hours FVC at all clinic visits |  | 12 weeks | 
| Trough FVC |  | at 6 and 12 weeks | 
| Individual FEV1 measurements |  | 12 weeks | 
| Individual FVC measurements |  | 12 weeks | 
| Use of Albuterol (scheduled and rescue) |  | 12 weeks | 
| Patient Global Evaluation |  | 12 weeks | 
| Physician Global Evaluation |  | 12 weeks | 
| PEFR (Peak expiratory flow rate) measured by the patient at home twice daily |  | 12 weeks | 
| Occurrence of adverse events |  | 12 weeks | 
| Vital Signs |  | 12 weeks |