Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild atopic asthma.
Phase IIa, placebo-controlled, randomized, double-blind, crossover single dose study to evaluate the safety, tolerability and efficacy of S-1226 (8%) administered by nebulization in subjects with mild atopic asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
The drug S1226(8%), consists of Perflubron (PFOB) and 8% CO2 delivered as an aerosol/vapour/gas mixture with a Circulaire nebulizer. The drug is administered as a single dose during the early phase asthmatic response for 2 minutes.
Normal saline nebulized with compressed medical air for 2 minutes during the early phase asthmatic response
Respiratory Clinical Trials Centre, University of Calgary
Calgary, Alberta, Canada
The number of treatment emergent adverse events (AEs).
Subjects will be closely monitored throughout the 2-minute drug and placebo administration periods and for 120 minutes following treatment. Treatment may be stopped at any time at the request of the subject and/or the qualified investigator or delegate. Safety and tolerability to S-1226 (8%) will be evaluated through the assessment of adverse events, vital signs, pulse oximetry, biochemistry and hematology testing, urinalysis, 12-lead ECG, physical examination, and pulmonary function (spirometry). These data will be recorded and descriptive statistics and change from baseline for safety parameters will be reported.
Time frame: 120 minutes
Evaluate the efficacy of S-1226 (8%) in comparison to placebo. (evaluated using area under the curve (AUC) of the early asthmatic response (defined as a 20% fall from baseline FEV1 following allergen inhalation)
Efficacy will be evaluated using area under the curve (AUC) of the early asthmatic response (defined as a 20% fall from baseline FEV1 following allergen inhalation), responder status which is achieving ≥ 25% reversal over placebo of the decrease in FEV1 from allergen challenge within 30 minutes after study treatment, maximum percent reversal of allergen-induced decrease in FEV1 in the first 30 minutes following study treatment administration, and the duration of the ≥ 25% reversal produced by study drug, defined as the interval after S-1226 (8%) administration during which the FEV1 is maintained at ≥ 25% above placebo.
Time frame: 30minutes
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