Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Phase 4

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00394485
• Lead Sponsor: Otsuka Pharmaceutical, Inc., Philippines

Brief Summary

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

Detailed Description

This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD.

After a 1-week wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-10-31
• Study First Submitted QC: 2006-10-31
• Study First Posted: 2006-11-01
• Study Completion: 2008-04
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-15
• Last Update Posted: 2009-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
[Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks

Secondary Outcome Measures

Name	Time	Method
[Safety] HR (Heart Rate) and BP (Blood Pressure)
Incidence of adverse reactions and changes

Trial Locations

Locations (1)

Philippine General Hospital; 🇵🇭 Manila, National Capital Region, Philippines