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

This study has been terminated.
(Lack of substantial enrollment)
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00402948
First received: November 21, 2006
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: TPI ASM8
Drug: ASM8
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • Sputum eosinophils at Day 1 and Day 14 and safety on Day 14 [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV 1 on Day 1 and Day 14 [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Rescue Medication (albuterol)for 21 days [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Blood eosinophils at Day 0 and Day 15 [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TPI ASM8
ASM8 0.25mg
Drug: TPI ASM8
0.25mg, 0.5mg for 14 days, daily dosage
Experimental: ASM8 as TPI ASM8
TPI ASM8 0.5mg
Drug: ASM8
inhalation 0.25mg daily for 14 days

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402948

Locations
Canada, Alberta
Calgary COPD & Asthma Program
Calgary, Alberta, Canada, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
St-Paul's Hospital
Vancouver, British Columbia, Canada, V6Z iY6
Canada, Ontario
McMaster University Hospital
Hamilton, Ontario, Canada, L8N 3 Z5
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N 4A6
Kingston General Hospital
Kingston, Ontario, Canada, K7L: 1O6
Canada, Quebec
Hopital Sacre Coeur
Montreal, Quebec, Canada, H4J 1G5
Institut Thoracique de Montreal
Montreal, Quebec, Canada, H2X 2P4
Canada
Hopital Laval- Centre de recherche de Cardiologie et Pneumologie
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: Parameswaram Nair, MD Firestone Institute for Respiratory Health
  More Information

No publications provided

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00402948     History of Changes
Other Study ID Numbers: TPI ASM8 -204
Study First Received: November 21, 2006
Last Updated: November 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by Pharmaxis:
High eosinophils level in sputum

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014