Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

Syntara

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: TPI ASM8

Study type: Interventional

Funder types: Industry

Identifiers

NCT01158898

TPI ASM8-207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 3 patient groups, including a placebo group

TPI ASM8 low dose

Active Comparator group

Treatment:

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

TPI ASM8 high dose

Active Comparator group

Treatment:

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8

Placebo

Placebo Comparator group

Treatment:

Drug: TPI ASM8

Drug: TPI ASM8

Drug: TPI ASM8