Evidence map›Paper›PMID 32484940›Full record

Trial reportBritish journal of clinical pharmacology2021

Therapeutic index of inhaled corticosteroids in asthma: A dose-response comparison on airway hyperresponsiveness and adrenal axis suppression.

Peter Daley-Yates, Noushin Brealey, Sebin Thomas, Daren Austin, Shaila Shabbir, Tim Harrison, Dave Singh, Neil Barnes

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02991859 (An Escalating Dose, Randomized, Placebo-controlled, Incomplete-block, 2-period Cross-over Study to Assess the Dose Response for Topical Efficacy Via Airway Responsiveness to Adenosine-5'-Monophosphate), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT02991859 phase2completednot on this map

An Escalating Dose, Randomized, Placebo-controlled, Incomplete-block, 2-period Cross-over Study to Assess the Dose Response for Topical Efficacy Via Airway Responsiveness to Adenosine-5'-Monophosphate (AMP) Challenge and the Dose Response for Systemic Activity Via 24h Plasma Cortisol Suppression and Thereby the Relative Therapeutic Index for Fluticasone Furoate (FF), Fluticasone Propionate (FP) and Budesonide (BUD) in Asthmatic Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2018Enrolled56ConditionsAsthmaArmsFluticasone furoate (FF) Dry Powder Inhaler, Fluticasone propionate (FP) Dry Powder Inhaler, Budesonide (BUD) Turbuhaler, Placebo (ELLIPTA or DISKUS)
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Inhaled Corticosteroid/Long-Acting βAdvances in therapy · 2026
    Review
  9. Observational
  10. Asthma and corticosteroids "Frontiers in allergy · 2026
    Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Iatrogenic adrenal insufficiency in adults.Nature reviews. Endocrinology · 2024
    Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Peter Daley-YatesClinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc, Uxbridge, UK.ORCID 0000-0003-0684-5621
Noushin BrealeyClinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc, Uxbridge, UK.
Sebin ThomasBiostatistics and Programming, GlaxoSmithKline plc, Bangalore, India.
Daren AustinClinical Pharmacology and Experimental Medicine, GlaxoSmithKline plc, Uxbridge, UK.
Shaila ShabbirMedicines Research Centre, GlaxoSmithKline plc, Stevenage, UK.
Tim HarrisonRespiratory Research Unit, Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.
Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.ORCID 0000-0001-8918-7075
Neil BarnesGlobal Medical Franchise, GlaxoSmithKline plc, Brentford, UK.
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (India) · INManchester University NHS Foundation Trust · GBQueen Mary University of London · GBUniversity of Nottingham · GB

Funding

GlaxoSmithKline plc 203162
6 · The paper itself

Abstract

aimsTo compare the airway potency, systemic activity and therapeutic index of three inhaled corticosteroids that differ in glucocorticoid receptor binding affinity, physicochemical and pharmacokinetic properties.

methodsThis escalating-dose, placebo-controlled, cross-over study randomised adults with asthma to 1 or 2 treatment periods with ≥25 days washout in-between. Each treatment period comprised five 7-day dose escalations (μg/d): fluticasone furoate (FF; 25 → 100 → 200 → 400 → 800), fluticasone propionate (FP; 50 → 200 → 500 → 1000 → 2000), budesonide (BUD; 100 → 400 → 800 → 1600 → 3200) or placebo. Airway hyperresponsiveness to adenosine-5'-monophosphate (AMP PC

resultsFifty-four subjects were randomised. FF showed greater airway potency than FP and BUD (AMP PC

conclusionThis study provides evidence that FF can provide more protection against airway hyperresponsiveness, with less systemic activity, than FP or BUD. This suggests that all inhaled corticosteroids are not therapeutically similar and may differ in their therapeutic index. (203162; NCT02991859).

Indexed as

Anti-Asthmatic AgentsAsthmaAdministration, InhalationAdrenal Cortex HormonesAdultAndrostadienesCross-Over StudiesDouble-Blind MethodFluticasoneHumansHydrocortisoneTherapeutic IndexAdrenal Cortex HormonesAndrostadienesAnti-Asthmatic AgentsFluticasoneHydrocortisoneAMP challengeasthmabudesonidefluticasone furoatefluticasone propionatetherapeutic index

Identifiers

PMID32484940
PMCPMC9328361
OpenAlexW3029301343

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.