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

NCT00402948 | Terminated Phase 2

• 1 other identifier: TPI ASM8 -204
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 10

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.

Conditions

Asthma

Keywords

High eosinophils level in sputum

Outcome Measures

Primary Outcomes (1)

• Sputum eosinophils at Day 1 and Day 14 and safety on Day 14

  Prospective

Secondary Outcomes (4)

• 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

Study Arms (2)

TPI ASM8

EXPERIMENTAL

ASM8 0.25mg

Drug: TPI ASM8

ASM8 as TPI ASM8

EXPERIMENTAL

TPI ASM8 0.5mg

Drug: ASM8

Interventions

TPI ASM8 DRUG

0.25mg, 0.5mg for 14 days, daily dosage

TPI ASM8

ASM8 DRUG

inhalation 0.25mg daily for 14 days

ASM8 as TPI ASM8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Syntara: lead

Study Sites (10)

Calgary COPD & Asthma Program

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St-Paul's Hospital

Vancouver, British Columbia, V6Z iY6, Canada

Location

McMaster University Hospital

Hamilton, Ontario, L8N 3 Z5, Canada

Location

Firestone Institute for Respiratory Health

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L: 1O6, Canada

Location

Institut Thoracique de Montreal

Montreal, Quebec, H2X 2P4, Canada

Location

Hopital Sacre Coeur

Montreal, Quebec, H4J 1G5, Canada

Location

Hopital Laval- Centre de recherche de Cardiologie et Pneumologie

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

TPI ASM8

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Parameswaram Nair, MD

  Firestone Institute for Respiratory Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: February 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

CA (10)