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

This study has been completed.
Information provided by (Responsible Party):
Pharmaxis Identifier:
First received: January 13, 2009
Last updated: November 14, 2013
Last verified: November 2013
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.

Condition Intervention Phase
Asthma Drug: TPI ASM8 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Pharmaxis:

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

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

Enrollment: 14
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose level No.1
Drug: TPI ASM8
4 mg/mL, 1 mg BID for 4 days
Other Name: ASM8
Experimental: Dose level No.2
Drug: TPI ASM8
4 mg/mL, 2 mg BID for 4 days
Other Name: ASM8
Experimental: Dose level No.3
Drug: TPI ASM8
4 mg/mL, 4 mg BID for 4 days
Other Name: ASM8
Experimental: Dose level No.4
TPI ASM8 8 mg Die
Drug: TPI ASM8
4 mg/mL, 8 mg OD for 4 days
Other Name: ASM8

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).
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Please refer to this study by its identifier: NCT00822861

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Study Director: Rene Pageau, B.Pharm M.Sc Topigen Pharmaceuticals Inc.
  More Information

Responsible Party: Pharmaxis Identifier: NCT00822861     History of Changes
Other Study ID Numbers: TPI ASM8-206
Study First Received: January 13, 2009
Last Updated: November 14, 2013

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on August 22, 2017