AsthmaPhase 2S-1226(8%)NCT02334553
Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma
A Phase 2 study testing S1226(8%) in people with Asthma, run by SolAeroMed Inc. at 1 site in Canada.
Trial summary
Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild atopic asthma. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Asthma
- What is being tested?
- S1226(8%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2015to 25 Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects 18-40 years of age.
- BMI of 18-40 kg/m2
- Subject is not currently on topical or systemic corticosteroids and has not taken any oral/injectable corticosteroid within 60 days prior to study drug administration and has not used any inhaled/nasal corticosteroid within 30 days prior to study drug administration.
- Female subjects must not be pregnant or lactating and must be practicing an acceptable method of birth control, or be surgically sterile or postmenopausal.
- Subjects must have had asthma for at least 3 months.
- Subject is a non-smoker or has not smoked for > 1year and has < 10 pack-year history.
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- Subject has a methacholine PC20 of less than 16mg/mL.
- Subject has normal laboratory values (normal values as clinically judged by the Investigator) for clinical chemistry, hematology, and urinalysis.
- Subject is in general good health based on medical history and clinically acceptable results for the following assessments: physical examination, vital signs, and 12-lead ECG, as assessed by study physicians.
- Subject is able to communicate effectively with study personnel and is reliable, willing and cooperative in terms of compliance with protocol.
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study:
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Subjects who require inhaled β2-agonist medication more frequently than 4 times a week (other than prophylactically prior to exercise) during the 4 week period before screening.
- Subjects who are currently treated with any asthma medication other than inhaled β2-agonist.
- Subjects with frequent emergency room visits for asthma, with prior ICU admission or those with prior intubation.
- Presence or history of neurologic, endocrine, hepatic, gastrointestinal or kidney disease or therapy that would jeopardize the subject's well-being by participating in the study.
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- Cardiovascular disease that, in the opinion of the Investigator, is not stable or could put the subject at increased risk by participating in the study.
- Any reason which, in the opinion of the Investigator (or delegate), would prevent the subject from participating in the study.
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- Subject has a history of physician diagnosed panic disorder or other anxiety disorders.
- Subject is currently receiving treatment, or has received treatment in the previous 14 days, with monoamine oxidase (MAO) inhibitors.
- Subjects dosed with an investigational drug within 30 days prior to the Screening Visit.
- Subjects dosed with biologic therapy within the previous 4 months or 5 half-lives from baseline methacholine testing.
- Subject has current (or within the last six months) evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit)
- Positive urine drug screen or urine cotinine test at screening.
- Breast-feeding subject.
- Positive pregnancy test at screening.
- Subject, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Respiratory Clinical Trials Centre, University of Calgary
Calgary, Alberta, T2N 4Z6
About this study
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.
Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild atopic asthma.
Read the detailed description
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
- Conditions
- Asthma
- Being tested
- S1226(8%), Placebo
- Keywords
- COPD, Chronic bronchitis, Cystic fibrosis, Bronchoconstriction, Perfluorocarbons, Carbon dioxide
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1226(8%)Drug
Also called PFOB nebulized with 8% CO2 in medical gas mixture
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.
PlaceboDrug
Also called normal saline nebulized with compressed medical air
Normal saline nebulized with compressed medical air for 2 minutes during the early phase asthmatic response
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: S1226(8%) |
| Placebo | Placebo comparator | The comparator is normal saline delivered as an aerosol with compressed medical air with a Circulaire nebulizer. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes
Secondary outcomes (1)
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.
Measured: 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study start6 Feb 2015
- Primary completion25 Nov 2015
- Study completion25 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- SolAeroMed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Leigh, MD, PhD, Principal investigator, Professor and Head, Respiratory Clinical Trials CentreVeronica Swystun, PhD, Study director, Respiratory Clinical Trials Centre, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334553
- Sponsor's protocol ID
- SAMi-02-1-02
- Acronym
- S-1226(8%)
- Status last verified
- Feb 2019
- First submitted
- 12 Nov 2014
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25355286Swystun 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.
PubMed 29914544
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02334553
- Acronym / sponsor ID
- S-1226(8%) / SAMi-02-1-02
- Conditions
- Asthma
- Keywords
- COPD, Chronic bronchitis, Cystic fibrosis, Bronchoconstriction, Perfluorocarbons, Carbon dioxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SolAeroMed Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 25 Nov 2015 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild atopic asthma.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S1226 (8%) | Active comparator | Drug: 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe comparator is normal saline delivered as an aerosol with compressed medical air with a Circulaire nebulizer. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects 18-40 years of age.
- BMI of 18-40 kg/m2
- Subject is not currently on topical or systemic corticosteroids and has not taken any oral/injectable corticosteroid within 60 days prior to study drug administration and has not used any inhaled/nasal corticosteroid within 30 days prior to study drug administration.
- Female subjects must not be pregnant or lactating and must be practicing an acceptable method of birth control, or be surgically sterile or postmenopausal.
- Subjects must have had asthma for at least 3 months.
Key exclusion criteria (18 listed)
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Subjects who require inhaled β2-agonist medication more frequently than 4 times a week (other than prophylactically prior to exercise) during the 4 week period before screening.
- Subjects who are currently treated with any asthma medication other than inhaled β2-agonist.
- Subjects with frequent emergency room visits for asthma, with prior ICU admission or those with prior intubation.
- Presence or history of neurologic, endocrine, hepatic, gastrointestinal or kidney disease or therapy that would jeopardize the subject's well-being by participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S1226(8%)Also: PFOB nebulized with 8% CO2 in medical gas mixtureThe 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. | Drug | S1226 (8%) |
| PlaceboAlso: normal saline nebulized with compressed medical airNormal saline nebulized with compressed medical air for 2 minutes during the early phase asthmatic response | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Background: PubMed 25355286El 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.
- Derived from this study: PubMed 29914544Swystun 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.
- Pre clinical sheep model for S-1226Link provided by the sponsor.
- Sponsoring company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Leigh, MD, PhD principal investigator
Professor and Head, Respiratory Clinical Trials Centre
Veronica Swystun, PhD study director
Respiratory Clinical Trials Centre, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S1226(8%) in people with Asthma, run by SolAeroMed Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of treatment emergent adverse events (AEs). (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02334553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.