Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma (S-1226(8%))
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02334553|
Recruitment Status : Unknown
Verified November 2015 by SolAeroMed Inc..
Recruitment status was: Recruiting
First Posted : January 8, 2015
Last Update Posted : November 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: S1226(8%) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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.|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||December 2015|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|