Evidence map›Paper›PMID 36471430›Full record

ArticleTrials2022

Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized controlled trial.

James G Krings, Kaitlyn M Wojcik, Vanessa Chen, Tejas C Sekhar, Kelly Harris, Abigail Zulich, Kaharu Sumino, Ross Brownson, Eric Lenze, Mario Castro

2 registry-linked trialsAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05111262 phase1 / phase2active not recruitingnot on this map

Symptom-driven Combination Inhaled Corticosteroids and Long-acting Beta Agonist Therapy for Patients With Asthma Who Are Identified as Non-adherent to Daily Maintenance Inhalers

TypeinterventionalSponsorWashington University School of MedicineRan2021 to 2028Enrolled60ConditionsAsthma, Nonadherence, MedicationArmsAdherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA
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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. 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

10 authors.

James G KringsDivision of Pulmonary and Critical Care Medicine, Washington University in Saint Louis School of Medicine, Saint Louis, MO, 63110, USA. kringsj@wustl.edu.ORCID http://orcid.org/0000-0003-0577-5481
Kaitlyn M WojcikBrown School of Social Work and Public Health, Washington University in Saint Louis, Saint Louis, MO, 63110, USA.
Vanessa ChenBrown School of Social Work and Public Health, Washington University in Saint Louis, Saint Louis, MO, 63110, USA.
Tejas C SekharDivision of Pulmonary and Critical Care Medicine, Washington University in Saint Louis School of Medicine, Saint Louis, MO, 63110, USA.
Kelly HarrisProgram in Occupational Therapy, Washington University in Saint Louis School of Medicine, Saint Louis, MO, 63110, USA.
Abigail ZulichDivision of Pulmonary and Critical Care Medicine, Washington University in Saint Louis School of Medicine, Saint Louis, MO, 63110, USA.
Kaharu SuminoDivision of Pulmonary and Critical Care Medicine, Washington University in Saint Louis School of Medicine, Saint Louis, MO, 63110, USA.
Ross BrownsonBrown School of Social Work and Public Health, Washington University in Saint Louis, Saint Louis, MO, 63110, USA.
Eric LenzeDivision of Psychiatry, Washington University in Saint Louis School of Medicine, Saint Louis, MO, 63110, USA.
Mario CastroDivision of Pulmonary Critical Care and Sleep Medicine, University of Kansas, Kansas City, KS, 66103, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile inhaled corticosteroids (ICS) are considered the essential foundation of most asthma therapy, ICS inhaler nonadherence is a notoriously common problem and a significant cause of asthma-related morbidity. Partially acknowledging the problem of nonadherence, international organizations recently made paradigm-shifting recommendations that all patients with mild-to-moderate persistent asthma be considered for symptom-driven ICS-containing inhalers rather than relying on adherence to traditional maintenance ICS inhalers and symptom-driven short-acting beta-agonists (SABA). With this new approach, asthma patients are at least exposed to the important anti-inflammatory effects of ICS-containing inhalers when their symptom reliever inhaler is deployed due to acute symptoms.

methodsThis study will (Part 1) complete a pragmatic randomized controlled trial to evaluate if an inhaler strategy that utilizes symptom-driven ICS inhalers is particularly beneficial in maintenance ICS inhaler non-adherent asthma patients, and (Part 2) use a dissemination and implementation (D&I) science conceptual framework to better understand patients' and providers' views of inhaler nonadherence. This study, which will have an option of taking place entirely remotely, will use a Food and Drug Administration (FDA)-approved electronic sensor (Hailie® sensor) to monitor inhaler adherence and includes semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR). DISCUSSION: This study is assessing the problem of nonadherence using a D&I implementation science research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence. We hypothesize that the use of a symptom-driven ICS/LABA management strategy, as compared to traditional maintenance ICS treatment and symptom-driven SABA, will lead to improved adherence to an asthma treatment strategy, decreased asthma-related morbidity, less cumulative ICS exposure, and greater patient satisfaction with an inhaler approach.

trial registrationClinicalTrials.gov NCT05111262. Registered on November 8, 2021.

Indexed as

Anti-Asthmatic AgentsAsthmaAdministration, InhalationAdrenal Cortex HormonesAdultHumansNebulizers and VaporizersPragmatic Clinical Trials as TopicAdrenal Cortex HormonesAnti-Asthmatic AgentsAsthmaInhalerMedication adherencePragmatic clinical trialQualitative

Identifiers

PMID36471430
PMCPMC9720948

What OpenQuestion holds

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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.