Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00394485
• Other study ID #: OPPI-MPTA-COPD-1
• Status: Terminated
• Phase: Phase 4
• First received: October 31, 2006
• Last updated: December 15, 2009
• Start date: May 2006
• Est. completion date: April 2008

Study information

• Verified date: December 2009
• Source: Otsuka Pharmaceutical, Inc., Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Procaterol

• Tiotropium

Locations

Country	Name	City	State
Philippines	Philippine General Hospital	Manila	National Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical, Inc., Philippines	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks
Secondary	[Safety] HR (Heart Rate) and BP (Blood Pressure)
Secondary	Incidence of adverse reactions and changes