Clinical trial NCT00483743: Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Copd Bronchitis
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 42 days
Secondary outcomes:
measure: 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.
timeFrame: 42 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of alberta Hsopital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Hospital Lung Center
state: British Columbia
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health
state: Ontario
city: Les Saules
country: Canada
facility: Clinique Medical Les Saules
state: Quebec
city: Mirabel
country: Canada
facility: Omnispec Clinical Research Inc.
state: Quebec
city: Montreal
country: Canada
facility: Hopital Thoracique Montreal-CSUM
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre Coeur de Montreal
state: Quebec
city: Pointe-Claire
country: Canada
facility: Kells Medical Research Group
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS -Hopital FLEURIMONT
state: Quebec
city: St-Leonard
country: Canada
facility: Complexe Medicale Langelier
state: Quebec
city: Ste-Foy
country: Canada
facility: Centre de Cardiologie et de Pneumologie de l'Université Laval
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Centre de Cardiologie et de Pneumologie de l'Université Laval
name: Francois Maltais, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Syntara
name: Rene Pageau, M.Sc Pharm
role: STUDY_DIRECTOR
References: