Evidence map›Paper›PMID 29914544›Full record

Trial reportTrials2018

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.

Veronica Swystun, Francis H Y Green, John H Dennis, Emmanouil Rampakakis, Gurkeet Lalli, Morenike Fadayomi, Andrea Chiu, Grishma Shrestha, Sharif Galal El Shahat, David Evan Nelson and 3 more

4 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02334553 phase2completednot on this map

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.

TypeinterventionalSponsorSolAeroMed Inc.Ran2015 to 2015Enrolled12ConditionsAsthmaArmsS1226(8%), Placebo
NCT03903913 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

A Phase IIa Open Label Study to Evaluate the Safety, Tolerability and Efficacy of S-1226 Administered by Nebulization in Subjects With Mild to Moderate Cystic Fibrosis and Non CF Bronchiectasis

TypeinterventionalSponsorSolAeroMed Inc.Ran2019 to 2022Enrolled12ConditionsCystic Fibrosis, BronchiectasisArmsS-1226
NCT04738136 phase2suspendednot on this mapstarted 2021, after this paper: background citation

A Randomized, Open-Label, Controlled, Phase II Study to Evaluate the Safety, Tolerability and Efficacy Of S-1226 In Hospitalized Subjects With Moderate Severity Covid-19 Bronchiolitis/Pneumonia

TypeinterventionalSponsorSolAeroMed Inc.Ran2021 to 2021Enrolled30ConditionsCovid19, SARS-CoV-2 InfectionArmsS-1226
NCT04949386 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

A Randomized, Placebo-Controlled Phase II Study To Evaluate The Safety, Tolerability And Efficacy Of S-1226 In Post-Covid-19 Subjects With Persistent Respiratory Symptoms.

TypeinterventionalSponsorSolAeroMed Inc.Ran2021 to 2022Enrolled48ConditionsPost Acute COVID-19 Syndrome, Long COVID, COVID-19 Respiratory InfectionArmsS-1226 (8%), Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Carbon dioxide and MAPK signalling: towards therapy for inflammation.Cell communication and signaling : CCS · 2023
    Review
  2. Humidified Warmed COFrontiers in medicine · 2020
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

Veronica SwystunDepartment of Medicine, University of Calgary, Calgary, AB, Canada.
Francis H Y GreenDepartment of Pathology & Laboratory Medicine, University of Calgary, Calgary, AB, Canada. fgreen@ucalgary.ca.ORCID http://orcid.org/0000-0001-9768-9366
John H DennisSolAeroMed Inc, 120-4838 Richard Rd SW, Calgary, AB, T3E 6L1, Canada.
Emmanouil RampakakisJSS, Montreal, QC, Canada.
Gurkeet LalliSolAeroMed Inc, 120-4838 Richard Rd SW, Calgary, AB, T3E 6L1, Canada.
Morenike FadayomiDepartment of Pathology & Laboratory Medicine, University of Calgary, Calgary, AB, Canada.
Andrea ChiuDepartment of Pathology & Laboratory Medicine, University of Calgary, Calgary, AB, Canada.
Grishma ShresthaDepartment of Pathology & Laboratory Medicine, University of Calgary, Calgary, AB, Canada.
Sharif Galal El ShahatSolAeroMed Inc, 120-4838 Richard Rd SW, Calgary, AB, T3E 6L1, Canada.
David Evan NelsonDepartment of Pathology & Laboratory Medicine, University of Calgary, Calgary, AB, Canada.
Tamer Y El MaysDepartment of Pathology & Laboratory Medicine, University of Calgary, Calgary, AB, Canada.
Cora A PieronSolAeroMed Inc, 120-4838 Richard Rd SW, Calgary, AB, T3E 6L1, Canada.
Richard LeighDepartment of Medicine, University of Calgary, Calgary, AB, Canada.
University of Calgary · CA

Funding

Alberta Innovates - Health Solutions 10004299
6 · The paper itself

Abstract

backgroundThis study evaluates a novel bronchodilator, S1226, for its efficacy in reversing allergen-induced bronchoconstriction in subjects with mild, allergic asthma. S1226 is a new class of bronchodilator that is an aerosol/vapor/gas mixture combining pharmacological and biophysical principles for a novel mode of action. It contains a potent bronchodilator gas (carbon dioxide or CO

methodsThis was a phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover single-dose clinical trial to evaluate the safety, tolerability, and efficacy of S1226 (8% CO

resultsNo significant safety issues were observed. All adverse events were non-serious, mild, and transient. There was a statistically significant decrease in peripheral blood oxygenation levels over time in the placebo group following allergen inhalation, whereas blood oxygenation was maintained at normal levels in the S1226-treated subjects (P = 0.028). This effect was greatest 5 min after start of treatment (P < 0.001). The recovery rate was faster but not significantly so (P = 0.272) for S1226 compared to the placebo at earlier time points (5, 10, and 15 min), as assessed by ≥12% reversal of FEV

conclusionsS1226 was safe, tolerated well, and provided bronchodilation and improved blood oxygenation in subjects with mild atopic asthma following allergen-induced bronchoconstriction. Additional studies to optimize the therapeutic response are indicated.

trial registrationClinicalTrials.gov, NCT02334553 . Registered on 12 November 2014.

Indexed as

Acute DiseaseAdministration, InhalationAdolescentAdultAlbertaAsthmaBronchoconstrictionBronchodilator AgentsCarbon DioxideCross-Over StudiesDouble-Blind MethodExpectorantsFemaleFluorocarbonsForced Expiratory VolumeHumansBronchodilator AgentsCarbon DioxideExpectorantsFluorocarbonsHydrocarbons, BrominatedOxygenperflubronAsthmaCarbon dioxide (CO2)Clinical trialNovel bronchodilatorPerflubronS1226

Identifiers

PMID29914544
PMCPMC6006836
OpenAlexW2808047733

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.