Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
TPI ASM8
TPI ASM8
TPI ASM8
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring Mild to moderate asthma, Allergen inhalation challenge
Eligibility 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
Sites / Locations
- Health Research Innovation Centre
- Vancouver Coastal Health Research Institute
- McMaster University
- Laval Centre de Pneumologie Chest Division
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
TPI ASM8 low dose
TPI ASM8 high dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
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
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
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)
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.)
We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01158898
Brief Title
Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmaxis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Mild to moderate asthma, Allergen inhalation challenge
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TPI ASM8 low dose
Arm Type
Active Comparator
Arm Title
TPI ASM8 high dose
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TPI ASM8
Intervention Description
ASM8 4mg/mL (low dose) daily for 14 days by inhalation
Intervention Type
Drug
Intervention Name(s)
TPI ASM8
Intervention Description
ASM8 4mg/mL (high dose) daily for 14 days by inhalation
Intervention Type
Drug
Intervention Name(s)
TPI ASM8
Intervention Description
Placebo PBS solution daily for 14 days by inhalation
Primary Outcome Measure Information:
Title
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
Description
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
Time Frame
Day 14 (Between 3-7 hr post-AIC)
Secondary Outcome Measure Information:
Title
Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment
Description
Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14.
Time Frame
Day 14
Title
Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge
Description
We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1
Time Frame
Day 13 and Day 15 (Pre & post AIC)
Title
Effect of ASM8 on mast cells (as measured by specific biomarkers)
Description
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
Time Frame
Day 14 (pre, post and and peri-AIC)
Title
Sputum inflammation indicators (Eos, neutrophils, etc.)
Description
We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.
Time Frame
Day 14 and Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul O'Byrne, MD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rene Pageau, M.Sc Pharm
Organizational Affiliation
Pharmaxis Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Louis-Philippe Boulet, MD
Organizational Affiliation
Hopital Laval, Quebec
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Leigh, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gail M Gauveau, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Fitzgerald, MD
Organizational Affiliation
Vancouver Coastal Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Research Innovation Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Vancouver Coastal Health Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Laval Centre de Pneumologie Chest Division
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of TPI ASM8 During a 14-Day Allergen Challenge
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