Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT01158898
First received: June 17, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.


Condition Intervention Phase
Asthma
Drug: TPI ASM8
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • Compare the AUC of the late asthmatic response (LAR) between treatments and placebo [ Time Frame: Day 14 (Between 3-7 hr post-AIC) ] [ Designated as safety issue: No ]
    The area under the curve fo the late asthmatic response(% fall in FEV1)(between 3-7 hrs post allergen challenge) will be compared between the 2 doses of TPI ASM8 and the placebo


Secondary Outcome Measures:
  • Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14.

  • Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge [ Time Frame: Day 13 and Day 15 (Pre & post AIC) ] [ Designated as safety issue: Yes ]
    We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1

  • Effect of ASM8 on mast cells (as measured by specific biomarkers) [ Time Frame: Day 14 (pre, post and and peri-AIC) ] [ Designated as safety issue: No ]
    The leukotriene E4 and 9-11B PGF2 wil be measured in urine and plasma to determine the level of mast cells activation following the allergen challenge

  • Sputum inflammation indicators (Eos, neutrophils, etc.) [ Time Frame: Day 14 and Day 15 ] [ Designated as safety issue: No ]
    We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.


Enrollment: 16
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TPI ASM8 low dose Drug: TPI ASM8
ASM8 4mg/mL (low dose) daily for 14 days by inhalation
Active Comparator: TPI ASM8 high dose Drug: TPI ASM8
ASM8 4mg/mL (high dose) daily for 14 days by inhalation
Placebo Comparator: Placebo Drug: TPI ASM8
Placebo PBS solution daily for 14 days by inhalation

Detailed Description:

Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild asthma, male and female aged 18-55 y.old
  • Steroid-naive, non-smoker
  • Dual responders

Exclusion Criteria:

  • Any chronic disease(unstable)
  • Immunosuppressed, recent or ongoing steroid intake
  • Methacholine PC 20 > 16 mg/mL
  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: NCT01158898

Locations
Canada, Alberta
Health Research Innovation Centre
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Canada
Laval Centre de Pneumologie Chest Division
Quebec, Canada, G1V4G5
Sponsors and Collaborators
Pharmaxis
Investigators
Study Chair: Paul O'Byrne, MD McMaster University
Study Director: Rene Pageau, M.Sc Pharm Pharmaxis Ltd
Principal Investigator: Louis-Philippe Boulet, MD Hopital Laval, Quebec
Principal Investigator: Richard Leigh, MD University of Calgary
Principal Investigator: Gail M Gauveau, PhD McMaster University
Principal Investigator: Mark Fitzgerald, MD Vancouver Coastal Health Research Institute
  More Information

No publications provided

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT01158898     History of Changes
Other Study ID Numbers: TPI ASM8-207
Study First Received: June 17, 2010
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Pharmaxis:
Mild to moderate asthma
Allergen inhalation challenge

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

ClinicalTrials.gov processed this record on July 31, 2014