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Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients

NCT00483743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2012-12-03

No results posted yet for this study

Summary

This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.

Conditions

  • Copd Bronchitis

Interventions

DRUG

TPI 1020

250 mcg/caps 2 caps BID x 42 days

DRUG

Budesonide

400mcg mcg capsules- 2 capsules BID

DRUG

Placebo

2 caps BID x42 days

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Francois Maltais, MD · Centre de Cardiologie et de Pneumologie de l'Université Laval

  • Rene Pageau, M.Sc Pharm · Syntara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483743 on ClinicalTrials.gov