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

Phase 2

Completed

• Conditions: Allergic Asthma
• Interventions: Biological: TPI ASM8; Biological: placebo

• Registration Number: NCT00550797
• Lead Sponsor: Syntara

Brief Summary

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

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 Timeline

• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-30
• Study Start: 2008-01
• Primary Completion: 2008-07
• Study Completion: 2008-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No.1 ASM8 (oligonucleotide)	TPI ASM8	TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation
Phosphate Buffer solution	placebo	Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation

Primary Outcome Measures

Name	Time	Method
Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response	Safety (Trial duration) + LAR (Day 14)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

King's College inLondon; 🇬🇧 London, United Kingdom