Official Title: “A Randomized, Double-Blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 Mcg Daily With Combivent MDI 2 Actuations Qid”

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.

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: tiotropium
• Drug: ipratropium bromide / albuterol

Inclusion Criteria:

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 (dete rmined at study visits): Post-bronchodilator FEV1 <= 70% (Visit 1) Pre-bronchodilator FEV1
• <= 65% of predicted and FEV1/FVC <= 70% (Visit 2)

Exclusion Criteria:

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 f ood 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00388882

Study ID Number: 205.346

ClinicalTrials.gov Identifier: NCT00388882

Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología)