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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S1226 (8%) | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | The comparator is normal saline delivered as an aerosol with compressed medical air with a Circulaire nebulizer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S1226(8%) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects to whom any of the following applies will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Leigh, MD, PhD | Professor and Head, Respiratory Clinical Trials Centre | Principal Investigator |
| Veronica Swystun, PhD | Respiratory Clinical Trials Centre, University of Calgary | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Clinical Trials Centre, University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25355286 | Background | El Mays TY, Choudhury P, Leigh R, Koumoundouros E, Van der Velden J, Shrestha G, Pieron CA, Dennis JH, Green FH, Snibson KJ. Nebulized perflubron and carbon dioxide rapidly dilate constricted airways in an ovine model of allergic asthma. Respir Res. 2014 Sep 16;15(1):98. doi: 10.1186/s12931-014-0098-x. | |
| 29914544 | Derived |
| Label | URL |
|---|---|
| Pre clinical sheep model for S-1226 | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Placebo | Drug | Normal saline nebulized with compressed medical air for 2 minutes during the early phase asthmatic response |
|
|
| 30minutes |
| Swystun V, Green FHY, Dennis JH, Rampakakis E, Lalli G, Fadayomi M, Chiu A, Shrestha G, El Shahat SG, Nelson DE, El Mays TY, Pieron CA, Leigh R. A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma. Trials. 2018 Jun 18;19(1):321. doi: 10.1186/s13063-018-2720-6. |
| Sponsoring company website | View source |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |