Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: TPI ASM8

• Registration Number: NCT01158898
• Lead Sponsor: Syntara

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.

Study Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-08
• Study Start: 2010-11
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TPI ASM8 low dose	TPI ASM8	-
TPI ASM8 high dose	TPI ASM8	-
Placebo	TPI ASM8	-

Primary Outcome Measures

Name	Time	Method
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo	Day 14 (Between 3-7 hr post-AIC)	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

Name	Time	Method
Sputum inflammation indicators (Eos, neutrophils, etc.)	Day 14 and Day 15	We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo.
Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment	Day 14	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	Day 13 and Day 15 (Pre & post AIC)	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)	Day 14 (pre, post and and peri-AIC)	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

Trial Locations

Locations (4)

Laval Centre de Pneumologie Chest Division; 🇨🇦 Quebec, Canada

Health Research Innovation Centre; 🇨🇦 Calgary, Alberta, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Vancouver Coastal Health Research Institute; 🇨🇦 Vancouver, British Columbia, Canada