Details sur la nouvelle étude de phase 2 avec Topigen

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

This study is not yet open for participant recruitment.
Verified by Topigen Pharmaceuticals May 2007
Sponsored by: Topigen Pharmaceuticals
Information provided by: Topigen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00483743

Purpose
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.
Condition Intervention Phase
COPD Patients
Drug: TPI 1020 versus budesonide
Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of arms in study: 3

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.
Further study details as provided by Topigen Pharmaceuticals:
Primary Outcome Measures:

* 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. [Time Frame: 42 days]


Secondary Outcome Measures:

* 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. [Time Frame: 42 days]


Total Enrollment: 56

Study start: August 2007; Expected completion: June 2008
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.

Eligibility
Ages Eligible for Study: 40 Years - 80 Years, Genders Eligible for Study: Both
Criteria

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.

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00483743

Francois Maltais, MD (418) 656-4747 Francois.Maltais @med.ulaval.ca
Julie Milot, MD (418) 656-4747 julie.milot@crhl.ulaval.ca

Canada, Quebec
Centre de Cardiologie et de Pneumologie de l’Université Laval, Ste-Foy, Quebec, G1V 4G5, Canada
Francois Maltais, M.D 418-656-4747 Francois.Maltais @med.ulaval.ca
Francois Maltais, MD, Principal Investigator

Hopital Thoracique Montreal-CSUM, Montreal, Quebec, Canada
Jean Bourbeau, MD 514-842-5901
Jean Bourbeau, MD, Sub-Investigator

Study chairs or principal investigators

Francois Maltais, MD, Principal Investigator, Centre de Cardiologie et de Pneumologie de l’Université Laval
Rene Pageau, M.Sc Pharm, Study Director, Topigen Pharmaceuticals

More Information
Study ID Numbers: TPI 1020-203
Last Updated: June 6, 2007
Record first received: May 23, 2007
ClinicalTrials.gov Identifier: NCT00483743
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on September 24, 2007

source : Clinicaltrials