Atopic Asthma Clinical Trial
Official title:
A Phase IIa Randomized Double-blind Placebo-controlled Two-way Cross-over Trial of the Effects of Repeat Doses of 50 mg AXP1275 Daily on the Asthmatic Response to a Pulmonary Allergen Challenge in Adults With Mild-to-Moderate Atopic Asthma
This is the first study in human patients with asthma that the sponsor is conducting in order to evaluate if there are signals that the investigational medication, AXP1275, may be a safe and effective treatment for asthma. The results of this study may help the sponsor to design additional studies.
This 2-way, randomized, double-blind crossover study in subjects with mild to moderate
atopic asthma is designed to compare the responses to allergen and methacholine challenges
within the same subject after approximately 2 weeks of treatment with AXP1275 50 mg or
placebo. A total of 20 subjects with asthma with a dual (early and late) asthmatic response
to an inhaled aeroallergen will be randomized to 1 of 2 treatment sequences (placebo then
AXP1275 or AXP1275 then placebo) in a double-blind fashion to receive either oral AXP1275 or
matching placebo, once-daily, for 14 days. The washout period between the 2 treatment
periods will be 14 to 21 days.
A post-treatment follow-up visit will occur 14 ± 3 days after completion of the second
treatment period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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