Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma

November 14, 2013 updated by: Pharmaxis

A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma

During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.

Study Type

Interventional

Enrollment (Actual)

14

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
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18 to 65 years of age
  • Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
  • History of episodic wheeze and shortness of breath
  • Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value
  • Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.

Exclusion Criteria:

  • Significant acute or chronic medical or psychiatric illness
  • Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks
  • Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose level No.1
TPI ASM8 1 mg BID
Drug: TPI ASM8
4 mg/mL, 1 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 2 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 4 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 8 mg OD for 4 days
Other Names:
  • ASM8
EXPERIMENTAL: Dose level No.2
TPI ASM8 2 mg BID
Drug: TPI ASM8
4 mg/mL, 1 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 2 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 4 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 8 mg OD for 4 days
Other Names:
  • ASM8
EXPERIMENTAL: Dose level No.3
TPI ASM8 4mg BID
Drug: TPI ASM8
4 mg/mL, 1 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 2 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 4 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 8 mg OD for 4 days
Other Names:
  • ASM8
EXPERIMENTAL: Dose level No.4
TPI ASM8 8 mg Die
Drug: TPI ASM8
4 mg/mL, 1 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 2 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 4 mg BID for 4 days
Other Names:
  • ASM8
Drug: TPI ASM8
4 mg/mL, 8 mg OD for 4 days
Other Names:
  • ASM8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sputum eosinophils (%) on Day 4 versus Screening for each dose level.
Time Frame: 7 and 24 hrs post-allergen challenge
7 and 24 hrs post-allergen challenge

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability.
Time Frame: Throughout the study
Throughout the study
Plasma and sputum pharmacokinetic profile at the two highest dose levels.
Time Frame: Dose level 3 and 4
Dose level 3 and 4

Collaborators and Investigators

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

Sponsor

Pharmaxis

Investigators

  • Study Director: Rene Pageau, B.Pharm M.Sc, Topigen Pharmaceuticals Inc.

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

April 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (ESTIMATE)

January 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPI ASM8-206

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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