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

Syntara

Status and phase: Completed; Phase 2

Conditions: Allergic Asthma

Treatments: Biological: placebo; Biological: TPI ASM8

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550797

TPI ASM8-205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

No.1 ASM8 (oligonucleotide)

Experimental group

Description:

TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation

Treatment:

Biological: TPI ASM8

Phosphate Buffer solution

Placebo Comparator group

Description:

Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation

Treatment:

Biological: placebo