Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

Phase 2

Terminated

• Conditions: Asthma
• Interventions: Drug: ASM8; Drug: TPI ASM8

• Registration Number: NCT00402948
• Lead Sponsor: Syntara

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

Study Timeline

• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-23
• Study Start: 2007-02
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASM8 as TPI ASM8	ASM8	TPI ASM8 0.5mg
TPI ASM8	TPI ASM8	ASM8 0.25mg

Primary Outcome Measures

Name	Time	Method
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14	Prospective

Secondary Outcome Measures

Name	Time	Method
FEV 1 on Day 1 and Day 14	Prospective
Rescue Medication (albuterol)for 21 days	Prospective
Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF	Prospective
Blood eosinophils at Day 0 and Day 15	Prospective

Trial Locations

Locations (10)

Hopital Sacre Coeur; 🇨🇦 Montreal, Quebec, Canada

Calgary COPD & Asthma Program; 🇨🇦 Calgary, Alberta, Canada

Hopital Laval- Centre de recherche de Cardiologie et Pneumologie; 🇨🇦 Quebec, Canada

McMaster University Hospital; 🇨🇦 Hamilton, Ontario, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Institut Thoracique de Montreal; 🇨🇦 Montreal, Quebec, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Firestone Institute for Respiratory Health; 🇨🇦 Hamilton, Ontario, Canada

Gordon and Leslie Diamond Health Care Centre; 🇨🇦 Vancouver, British Columbia, Canada

St-Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada