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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of 14-day Inhaled TPI ASM8 in Subjects With Asthma

Conditions
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Allergic Asthma

Intervention / Treatment
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* Biological: TPI ASM8
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No.1 ASM8 (oligonucleotide)<br>TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation | Biological: TPI ASM8<br>* Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each<br>|
| Placebo Comparator: Phosphate Buffer solution<br>Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation | Biological: placebo<br>* Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response |  | Safety (Trial duration) + LAR (Day 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma |  | study duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroid-naive, non-smokers, Mild to moderate allergic asthmatic adults