Evidence map›Paper›PMID 33091192›Full record

Trial reportClinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2021

INEXAS: A Phase 2 Randomized Trial of On-demand Inhaled Interferon Beta-1a in Severe Asthmatics.

Christopher McCrae, Marita Olsson, Per Gustafson, Anna Malmgren, Malin Aurell, Malin Fagerås, Carla A Da Silva, Anders Cavallin, Jonathan Paraskos, Karin Karlsson and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.7field-weighted citation impact, top 15% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Asthma Phenotypes and Biomarkers.Respiratory care · 2025
    Review
  6. Article
  7. New targets for type 2-low asthma.The Korean journal of internal medicine · 2024
    Review
  8. Can Allergen Immunotherapy Improve Antiviral Immunity in Patients with Allergic Asthma?American journal of respiratory and critical care medicine · 2023
    Article
  9. Article
  10. Review
  11. Airway Epithelial Innate Immunity.Frontiers in physiology · 2021
    Article
  12. Article
  13. Review
  14. Review
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

14 authors at 5 institutions in 3 countries.

Christopher McCraeTranslational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.ORCID 0000-0001-7184-9069
Marita OlssonEarly Biometrics and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Per GustafsonBioPharmaceutical Medical, AstraZeneca, Gothenburg, Sweden.
Anna MalmgrenEarly Respiratory & Immunology Projects Department, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Malin AurellEarly Respiratory & Immunology Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Malin FageråsBioPharmaceutical Medical, AstraZeneca, Gothenburg, Sweden.
Carla A Da SilvaEarly Respiratory & Immunology Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Anders CavallinTranslational Science and Experimental Medicine, Early Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Jonathan ParaskosPoint of Care Diagnostics, Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, UK.
Karin KarlssonTranslational Science and Experimental Medicine, Early Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Cecilia WingrenTranslational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Phillip MonkSynairgen Research Ltd, Southampton University Hospital, Southampton, UK.
Richard MarsdenSynairgen Research Ltd, Southampton University Hospital, Southampton, UK.
Tim HarrisonNottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham City Hospital, Nottingham, UK.
AstraZeneca (Sweden) · SEAstraZeneca (United States) · USUniversity Hospital Southampton NHS Foundation Trust · GBAstraZeneca (United Kingdom) · GBUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUpper respiratory tract infections (URTIs) are important triggers for asthma exacerbations. We hypothesized that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.

objectiveTo evaluate the efficacy of on-demand inhaled IFN-β1a (AZD9412) to prevent severe asthma exacerbations following symptomatic URTI.

methodsThis was a randomized, double-blind, placebo-controlled trial in which patients with severe asthma (GINA 4-5; n = 121) reporting URTI symptoms were randomized to 14 days of once-daily nebulized AZD9412 or placebo. The primary endpoint was severe exacerbations during treatment. Secondary endpoints included 6-item asthma control questionnaire (ACQ-6) and lung function. Exploratory biomarkers included IFN-response markers in serum and sputum, blood leucocyte counts and serum inflammatory cytokines.

resultsFollowing a pre-planned interim analysis, the trial was terminated early due to an unexpectedly low exacerbation rate. Asthma worsenings were generally mild and tended to peak at randomization, possibly contributing to the lack of benefit of AZD9412 on other asthma endpoints. Numerically, AZD9412 did not reduce severe exacerbation rate, ACQ-6, asthma symptom scores or reliever medication use. AZD9412 improved lung function (morning peak expiratory flow; mPEF) by 19.7 L/min. Exploratory post hoc analyses indicated a greater mPEF improvement by AZD9412 in patients with high blood eosinophils (>0.3 × 10 CONCLUSIONS & CLINICAL RELEVANCE: Colds did not have the impact on asthma patients that was expected and, due to the low exacerbation rate, the trial was stopped early. On-demand AZD9412 treatment did not numerically reduce the number of exacerbations, but did attenuate URTI-induced worsening of mPEF. Severe asthma patients with high blood eosinophils or low serum interleukin-18 response are potential subgroups for further investigation of inhaled IFN-β1a.

Indexed as

Administration, InhalationAdultAntiviral AgentsAsthmaCytokinesDisease ProgressionDouble-Blind MethodFemaleHumansInterferon beta-1aMaleMiddle AgedPeak Expiratory Flow RateRespiratory Tract InfectionsSeverity of Illness IndexAntiviral AgentsCytokinesInterferon beta-1aasthmaeosinophilsexacerbationIFN responseIL-18interferonviral URTI

Identifiers

PMID33091192
PMCPMC7984268
OpenAlexW3094592496

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.