Official Title: “A Randomized, Double-Blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 Mcg Daily to Combivent MDI 2 Actuations Qid in COPD Patients Previously Prescribed Combivent 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.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: tiotropium
  • 18 mcg qd
• Drug: ipratropium bromide / albuterol
  • 18 mcg ipratropium bromide /120 mcg albuterol sulfate

Primary Measures

• Trough and AUC0-6 FEV1 after 12 weeks.
  • Time Frame: 12 weeks
    

Secondary Measures

• Peak FEV1, FVC (trough, peak, AUC0-6), FEV1 and FVC at each timepoint, trough FEV1 at 6 weeks, albuterol use, Patient and Physician Global Evaluations, daily PEFR
  • Time Frame: 6 weeks and 12 weeks
    

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 (determined 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 fr om 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

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 August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00359788

Study ID Number: 205.325

ClinicalTrials.gov Identifier: NCT00359788

Health Authority: United States: Food and Drug Administration