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

Phase 2

Completed

• Conditions: Copd Bronchitis
• Interventions: Drug: TPI 1020; Drug: Budesonide; Drug: Placebo

• Registration Number: NCT00483743
• Lead Sponsor: Syntara

Brief 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.

Detailed Description

A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects.

Study Timeline

• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-07
• Study Start: 2007-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years.
• Age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate COPD

Exclusion Criteria

• COPD exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study.
• Failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for TCC and differential cell count determination.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPI 1020	TPI 1020	TPI 1020 500 mcg BID x 42 days
Budosenide cortico	Budesonide	Budesonide 800 mcg BID x 42 days
Placebo	Placebo	Placebo inhaler

Primary Outcome Measures

Name	Time	Method
To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42.	42 days

Secondary Outcome Measures

Name	Time	Method
Sputum neutrophil counts on Days 0 and 21. • Trough FEV1, SVC and IC on Days 0, 21 and on Day 42. • eNO levels on Days 0, 21 and on Day 42.	42 days

Trial Locations

Locations (13)

CHUS -Hopital FLEURIMONT; 🇨🇦 Sherbrooke, Quebec, Canada

Clinique Medical Les Saules; 🇨🇦 Les Saules, Quebec, Canada

Firestone Institute for Respiratory Health; 🇨🇦 Hamilton, Ontario, Canada

Diex Research Inc.; 🇨🇦 Sherbrooke, Quebec, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Hopital Sacre Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada

Complexe Medicale Langelier; 🇨🇦 St-Leonard, Quebec, Canada

Centre de Cardiologie et de Pneumologie de l'Université Laval; 🇨🇦 Ste-Foy, Quebec, Canada

Omnispec Clinical Research Inc.; 🇨🇦 Mirabel, Quebec, Canada

Hopital Thoracique Montreal-CSUM; 🇨🇦 Montreal, Quebec, Canada

Vancouver Hospital Lung Center; 🇨🇦 Vancouver, British Columbia, Canada

University of alberta Hsopital; 🇨🇦 Edmonton, Alberta, Canada

Kells Medical Research Group; 🇨🇦 Pointe-Claire, Quebec, Canada