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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
TPI ASM8
ASM8
Sponsored by
Pharmaxis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring High eosinophils level in sputum

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Calgary COPD & Asthma Program
  • University of Alberta Hospital
  • Gordon and Leslie Diamond Health Care Centre
  • St-Paul's Hospital
  • McMaster University Hospital
  • Firestone Institute for Respiratory Health
  • Kingston General Hospital
  • Institut Thoracique de Montreal
  • Hopital Sacre Coeur
  • Hopital Laval- Centre de recherche de Cardiologie et Pneumologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TPI ASM8

ASM8 as TPI ASM8

Arm Description

ASM8 0.25mg

TPI ASM8 0.5mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2006
Last Updated
November 30, 2012
Sponsor
Pharmaxis
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1. Study Identification

Unique Protocol Identification Number
NCT00402948
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of substantial enrollment
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmaxis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
High eosinophils level in sputum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPI ASM8
Arm Type
Experimental
Arm Description
ASM8 0.25mg
Arm Title
ASM8 as TPI ASM8
Arm Type
Experimental
Arm Description
TPI ASM8 0.5mg
Intervention Type
Drug
Intervention Name(s)
TPI ASM8
Intervention Description
0.25mg, 0.5mg for 14 days, daily dosage
Intervention Type
Drug
Intervention Name(s)
ASM8
Intervention Description
inhalation 0.25mg daily for 14 days
Primary Outcome Measure Information:
Title
Sputum eosinophils at Day 1 and Day 14 and safety on Day 14
Time Frame
Prospective
Secondary Outcome Measure Information:
Title
FEV 1 on Day 1 and Day 14
Time Frame
Prospective
Title
Rescue Medication (albuterol)for 21 days
Time Frame
Prospective
Title
Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF
Time Frame
Prospective
Title
Blood eosinophils at Day 0 and Day 15
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parameswaram Nair, MD
Organizational Affiliation
Firestone Institute for Respiratory Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary COPD & Asthma Program
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Gordon and Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St-Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z iY6
Country
Canada
Facility Name
McMaster University Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3 Z5
Country
Canada
Facility Name
Firestone Institute for Respiratory Health
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L: 1O6
Country
Canada
Facility Name
Institut Thoracique de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Hopital Sacre Coeur
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1G5
Country
Canada
Facility Name
Hopital Laval- Centre de recherche de Cardiologie et Pneumologie
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

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

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