Evidence map›Paper›PMID 39240503›Full record

ArticleAdvances in therapy2024

Baseline Characteristics and Maintenance Therapy Choice on Symptom Control, Reliever Use, Exacerbation Risk in Moderate-Severe Asthma: A Clinical Modelling and Simulation Study.

Pierluigi Paggiaro, Gabriel Garcia, Nicolas Roche, Manish Verma, Maximilian Plank, Sean Oosterholt, Janna K Duong, Anurita Majumdar, Oscar Della Pasqua

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PubMed Full text at PMC Publisher
In one paragraph

Article in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

9 authors.

Pierluigi PaggiaroUniversity of Pisa, Pisa, Italy.
Gabriel GarciaRespiratory Research Center, CEPIR, La Plata, Argentina.
Nicolas RocheHôpital Cochin, Paris, France.
Manish VermaGSK, Mumbai, India.
Maximilian PlankGSK, Munich, Germany.
Sean OosterholtGSK, London, UK.
Janna K DuongGSK, Sydney, Australia.
Anurita MajumdarGSK, Singapore, Singapore.
Oscar Della PasquaGSK, 79 New Oxford St, London, WC1A 1DG, UK. odp72514@gsk.com.ORCID 0000-0002-6211-1430

Funding

GlaxoSmithKline Study 218915
6 · The paper itself

Abstract

introductionAlthough some factors associated with asthma symptom deterioration and risk of exacerbation have been identified, these are not yet fully characterised. We conducted a clinical modelling and simulation study to understand baseline factors affecting symptom control, reliever use and exacerbation risk in patients with moderate-severe asthma during follow-up on regularly dosed inhaled corticosteroid (ICS) monotherapy, or ICS/long-acting beta

methodsIndividual patient data from randomised clinical trials (undertaken between 2001 and 2019) were used to model the time course of symptoms (n = 7593), patterns of reliever medication use (n = 3768) and time-to-first exacerbation (n = 6763), considering patient-specific and extrinsic factors, including treatment. Model validation used standard graphical and statistical criteria. Change in symptom control scores (Asthma Control Questionnaire 5 [ACQ-5]), reduction in reliever use and annualised exacerbation rate were then simulated in patient cohorts with different baseline characteristics and treatment settings.

resultsBeing a smoker, having higher baseline ACQ-5 and body mass index affected symptom control scores, reliever use and exacerbation risk (p < 0.01). In addition, low forced expiratory volume in 1 s percent predicted, female sex, season and previous exacerbations were found to contribute to a further increase in exacerbation risk (p < 0.01), whereas long asthma history was associated with more frequent reliever use (p < 0.01). These effects were independent from the underlying maintenance therapy. In different scenarios, fluticasone furoate (FF)/vilanterol was associated with greater reductions in reliever use and exacerbation rates compared with FF or fluticasone propionate (FP) alone or budesonide/formoterol, independently from other factors (p < 0.01).

conclusionsThis study provided further insight into the effects of individual baseline characteristics on treatment response and highlighted significant differences in the performance of ICS/LABA combination therapy on symptom control, reliever use and exacerbation risk. These factors should be incorporated into clinical practice as the basis for tailored management of patients with moderate-severe asthma.

Indexed as

Adrenergic beta-2 Receptor AgonistsAsthmaAdministration, InhalationAdrenal Cortex HormonesAdultAgedAnti-Asthmatic AgentsComputer SimulationDisease ProgressionDrug CombinationsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAnti-Asthmatic AgentsDrug CombinationsAsthma control questionnaire 5Asthma exacerbationBudesonide/formoterolClinical trial simulationsDrug–disease modellingFluticasone furoate/vilanterolFluticasone propionateReliever medication useShort-acting beta2-agonistTreatable traits

Identifiers

PMID39240503
PMCPMC11480127

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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.