Title
Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma
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
Phase
Phase 2Lead Sponsor
PharmaxisStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Allergic AsthmaIntervention/Treatment
tpi asm8 ...Study Participants
18The 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.
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation
Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation
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
