Evidence map›Paper›PMID 39193207›Full record

ArticleJournal of asthma and allergy2024

A Fully Decentralized Randomized Controlled Study of As-Needed Albuterol-Budesonide Fixed-Dose Inhaler in Mild Asthma: The BATURA Study Design.

Craig LaForce, Frank C Albers, Mark Cooper, Anna Danilewicz, Lynn Dunsire, Robert Rees, Christy Cappelletti

2 registry-linked trialsAbstract read
In one paragraph

Article in Journal of asthma and allergy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT05505734 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Parallel-group, Event-driven, Decentralized, Phase IIIb Study Comparing PT027 With PT007 Administered as Needed in Participants 12 Years of Age and Older With Asthma (BATURA)

TypeinterventionalSponsorBond Avillion 2 Development LPRan2022 to 2024Enrolled2,516ConditionsAsthmaArmsBDA MDI, AS MDI
NCT07224061 narecruitingnot on this mapstarted 2026, after this paper: background citation

Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)

TypeinterventionalSponsorMontefiore Medical CenterRan2026 to 2033Enrolled420ConditionsAsthma in ChildrenArmsPRAGMATIC-S
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Identifying and Addressing the Hidden Risks of Mild Asthma.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2025
    Article
  2. 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

7 authors.

Craig LaForceNorth Carolina Clinical Research, Chapel Hill, NC, USA.
Frank C AlbersAvillion, Northbrook, IL, USA.ORCID 0000-0001-7039-4621
Mark CooperBioPharmaceuticals Research and Development, AstraZeneca, Cambridge, UK.ORCID 0009-0009-4634-7062
Anna DanilewiczAvillion, London, UK.
Lynn DunsireBioPharmaceuticals Research and Development, AstraZeneca, Cambridge, UK.
Robert ReesAvillion, London, UK.
Christy CappellettiBioPharmaceuticals Research and Development, AstraZeneca, Durham, NC, USA.ORCID 0000-0002-7203-7721

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Decentralized clinical trials, where trial-related activities occur at locations other than traditional clinical sites(eg participant homes, local healthcare facilities), have the potential to improve trial access for people for whom time and/or distance constraints may impede participation. Albuterol-budesonide 180/160 µg pressurized metered-dose inhaler (pMDI) is FDA approved for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years or older. BATURA (NCT05505734) is a fully decentralized study, investigating as-needed albuterol-budesonide in participants with mild asthma. Methods: BATURA is a fully decentralized, phase 3b, randomized, double-blind, event-driven exacerbation study conducted in the United States. Participants aged ≥12 years using as-needed short-acting β Conclusion: BATURA evaluates as-needed albuterol-budesonide in participants with mild asthma. The decentralized study model enables the trial to move out of research sites into participant homes, reducing participant burden and improving access.

Indexed as

albuterol–budesonidedecentralized clinical trialsSABA–ICStrial design

Identifiers

PMID39193207
PMCPMC11348984

What OpenQuestion holds

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LicenceCC BY-NC
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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.