Asthma
Conditions
Keywords
Mild to moderate asthma, Allergen inhalation challenge
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.
Interventions
DRUGTPI ASM8
ASM8 4mg/mL (low dose) daily for 14 days by inhalation
Sponsors
Syntara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Canada
Outcome results
None listed