Nouvelle phase II pour le TPI-1020

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

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

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.

Source : Clinical Trials

Merci à Gegen37 pour avoir trouvé l'info :)

Aucun commentaire: