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

Copd Bronchitis Clinical Trial

Official title:

Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled, 6-week Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483743
• Other study ID #: TPI 1020-203
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2007
• Last updated: November 30, 2012
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Copd Bronchitis

Intervention

Drug:
• TPI 1020
250 mcg/caps 2 caps BID x 42 days
• Budesonide
400mcg mcg capsules- 2 capsules BID
• Placebo
2 caps BID x42 days

Locations

Country	Name	City	State
Canada	University of alberta Hsopital	Edmonton	Alberta
Canada	Firestone Institute for Respiratory Health	Hamilton	Ontario
Canada	Clinique Medical Les Saules	Les Saules	Quebec
Canada	Omnispec Clinical Research Inc.	Mirabel	Quebec
Canada	Hopital Sacre Coeur de Montreal	Montreal	Quebec
Canada	Hopital Thoracique Montreal-CSUM	Montreal	Quebec
Canada	Kells Medical Research Group	Pointe-Claire	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	CHUS -Hopital FLEURIMONT	Sherbrooke	Quebec
Canada	Diex Research Inc.	Sherbrooke	Quebec
Canada	Complexe Medicale Langelier	St-Leonard	Quebec
Canada	Centre de Cardiologie et de Pneumologie de l'Université Laval	Ste-Foy	Quebec
Canada	Vancouver Hospital Lung Center	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No