Evidence map›Paper›PMID 39655310›Full record

ReviewContemporary clinical trials communications2024

Run-in periods and treatment outcomes in asthma trials: A narrative review.

Emilio Pizzichini, Guy Brusselle, Dawn Edwards, Peter G Gibson, Huib A Kerstjens, Alison Moore, David Slade, Robert A Wise, Shiyuan Zhang

Abstract readReview
In one paragraph

Review in Contemporary clinical trials communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Trial
  2. Trial
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.

Emilio PizzichiniGSK, London, UK.
Guy BrusselleGhent University Hospital, Ghent, Belgium.
Dawn EdwardsGSK, London, UK.
Peter G GibsonDepartment of Respiratory and Sleep Medicine, John Hunter Hospital, Hunter Medical Research Institute, Newcastle 2305, Australia.
Huib A KerstjensUniversity of Groningen and University Medical Center Groningen and Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.
Alison MooreGSK, London, UK.
David SladeGSK, Research Triangle Park, NC, USA.
Robert A WiseJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Shiyuan ZhangGSK, Collegeville, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The run-in period is an important element of randomized controlled trials, and is often used in respiratory disease trials. The design of the run-in period can greatly impact results and data interpretation, and as such should be designed carefully. Methods: In this review, we describe the design of run-in periods across six phase 3A trials of triple therapy in asthma, and discuss how differences in run-in period design (specifically the duration, treatment, and reporting of run-in results) may have the potential to alter the interpretation of study outcomes. Results: We found that the duration of run-in periods ranged between 2 and 7 weeks, with some studies including a combination of screening, run-in and stabilization periods, and others including a run-in period only. Run-in treatment also varied, with some studies running in patients on their previous inhaled corticosteroid/long-acting β Conclusion: We discuss the potential implications associated with the various trial designs, and propose that run-in periods should be consciously designed to meet the goals of the specific study. We also propose that standardized reporting of run-in changes would further allow for differentiation between improvements due to improved adherence and true treatment benefits, and aid with comparing data from different clinical trials.

Indexed as

Asthma exacerbationsAsthma outcomes researchAsthma therapy

Identifiers

PMID39655310
PMCPMC11626073

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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.