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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 COPD patients currently prescribed Combivent® MDI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Albuterol; Bromides; Ipratropium; Tiotropium Bromide

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:

• 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