Clinical trial NCT00402948: Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, To Evaluate And Compare The Safety, Tolerability And Efficacy Of Two Dosages Of Inhaled TPI ASM8 Administered For 14 Days In Patients With Mild to Moderate Asthma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: High eosinophils level in sputum
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Age 18-65 y. old, non or ex-smokers for \> 6 months
* Mild to moderate asthmatic in general good health
* On either low-dose inhaled corticosteroid or steroid naive
* No other asthma medication
* Regular sputum producer
* EOS more than 3% at randomization,
* FEV1 \> 70%

Exclusion Criteria:

* Respiratory infection within last 4 weeks
* Any condition that may affect the conduct of the study as per the investigators

Primary outcomes:
measure: Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
timeFrame: Prospective
Secondary outcomes:
measure: FEV 1 on Day 1 and Day 14
timeFrame: Prospective
measure: Rescue Medication (albuterol)for 21 days
timeFrame: Prospective
measure: Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF
timeFrame: Prospective
measure: Blood eosinophils at Day 0 and Day 15
timeFrame: Prospective
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary COPD & Asthma Program
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: St-Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Institut Thoracique de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre Coeur
state: Quebec
city: Quebec
country: Canada
facility: Hopital Laval- Centre de recherche de Cardiologie et Pneumologie
Study officials:
affiliation: Firestone Institute for Respiratory Health
name: Parameswaram Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: