Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

NCT00394485 | Terminated Phase 4

• 1 other identifier: OPPI-MPTA-COPD-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; Procaterol; Tiotropium

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• [Safety] HR (Heart Rate) and BP (Blood Pressure)

• Incidence of adverse reactions and changes

Interventions

Procaterol DRUG

Tiotropium DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GOLD criteria for moderate COPD (post-bronchodilator)
• FEV1/FVC \< 70%
• % ≤ FEV1 \< 80% predicted
• With or without symptoms
• Willing to undergo the treatment protocol with signed informed consent

You may not qualify if:

• Exacerbation within 1 month prior to run-in period
• Significant hypoxemia and/or desaturation at rest and during exercise.
• Significant cardiac, renal, or other systemic disease
• History of adverse reaction to any of the two test drugs (tiotropium and procaterol)

Sponsors & Collaborators

• Otsuka Pharmaceutical, Inc., Philippines: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Procaterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Abundio A Balgos, MD

  University of the Philippines College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Study Start: May 1, 2006
• Study Completion: April 1, 2008
• Last Updated: December 17, 2009

Record last verified: 2009-12

Locations

PH (1)