Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma

Syntara18 enrolled

Overview

The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.

Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Asthma

Interventions

TPI ASM8BIOLOGICAL

Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

placeboBIOLOGICAL

Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women 18 to 65 years of age * Intermittent mild to moderate allergic asthma as defined by ATS/ERS criteria * History of episodic wheeze and shortness of breath Exclusion Criteria: * Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness, asthma exacerbation or respiratory infection in the preceding 6 weeks * Use of oral/injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs or anticoagulants

Locations (1)

King's College inLondon

London, London, United Kingdom

Outcomes

Primary Outcomes

Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response

Time frame: Safety (Trial duration) + LAR (Day 14)

Secondary Outcomes

Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma

Time frame: study duration

Data from ClinicalTrials.gov

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