Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma (S-1226(8%))
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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.|
- The number of treatment emergent adverse events (AEs). [ Time Frame: 120 minutes ]
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.
- 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) [ Time Frame: 30minutes ]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.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Active Comparator: S1226 (8%)
The drug S1226(8%), consists of Perflubron and 8% CO2 in a medical gas mixture. The dosage is 3ml delivered as an aerosol/vapour/gas mixture with a Circulaire nebulizer.
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.
Other Name: PFOB nebulized with 8% CO2 in medical gas mixture
Placebo Comparator: Placebo
The comparator is normal saline delivered as an aerosol with compressed medical air with a Circulaire nebulizer.
Normal saline nebulized with compressed medical air for 2 minutes during the early phase asthmatic response
Other Name: normal saline nebulized with compressed medical air
Please refer to this study by its ClinicalTrials.gov identifier: NCT02334553
|Contact: John Dennis, PhDfirstname.lastname@example.org|
|Contact: Francis Green, MBChB, MDemail@example.com|
|Respiratory Clinical Trials Centre, University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N 4Z6|
|Contact: Richard Leigh, M D, PhD 403-220-8981 firstname.lastname@example.org|
|Contact: Veronica Swystun, PhD 403 220 3522 email@example.com|
|Principal Investigator:||Richard Leigh, MD, PhD||Professor and Head, Respiratory Clinical Trials Centre|
|Study Director:||Veronica Swystun, PhD||Respiratory Clinical Trials Centre, University of Calgary|