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

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ClinicalTrials.gov Identifier: NCT00822861
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pharmaxis

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: TPI ASM8 Phase 2

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  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : April 2009
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 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



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

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00822861     History of Changes
Other Study ID Numbers: TPI ASM8-206
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

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