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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00822861
First received: January 13, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Plasma and sputum pharmacokinetic profile at the two highest dose levels. [ Time Frame: Dose level 3 and 4 ] [ Designated as safety issue: No ]

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
TPI ASM8 1 mg BID
Drug: TPI ASM8
4 mg/mL, 1 mg BID for 4 days
Other Name: ASM8
Experimental: Dose level No.2
TPI ASM8 2 mg BID
Drug: TPI ASM8
4 mg/mL, 2 mg BID for 4 days
Other Name: ASM8
Experimental: Dose level No.3
TPI ASM8 4mg BID
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822861

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

No publications provided

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00822861     History of Changes
Other Study ID Numbers: TPI ASM8-206
Study First Received: January 13, 2009
Last Updated: November 14, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014