Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease

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

Details

• Lead Sponsor: Otsuka Pharmaceutical, Inc., Philippines
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Procaterol; Tiotropium Bromide

Criteria

Inclusion Criteria:

1. GOLD criteria for moderate COPD (post-bronchodilator)

• FEV1/FVC < 70%

• 50% ≤ FEV1 < 80% predicted

• With or without symptoms

2. Willing to undergo the treatment protocol with signed informed consent

Exclusion Criteria:

1. Exacerbation within 1 month prior to run-in period

2. Significant hypoxemia and/or desaturation at rest and during exercise.

3. Significant cardiac, renal, or other systemic disease

4. History of adverse reaction to any of the two test drugs (tiotropium and procaterol)