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

November 30, 2012 updated by: Pharmaxis

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
Time Frame: Prospective
Prospective

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaxis

Investigators

  • Principal Investigator: Parameswaram Nair, MD, Firestone Institute for Respiratory Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPI ASM8 -204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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