- Title
- Run-in periods and treatment outcomes in asthma trials: A narrative review
- Creator
- Pizzichini, Emilio; Brusselle, Guy; Edwards, Dawn; Gibson, Peter G.; Kerstjens, Huib A.; Moore, Alison; Slade, David; Wise, Robert A.; Zhang, Shiyuan
- Relation
- Contemporary Clinical Trials Communications Vol. 42, Issue December 2024, no. 101382
- Publisher Link
- http://dx.doi.org/10.1016/j.conctc.2024.101382
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2024
- Description
- 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 β2-agonist (ICS/LABA) therapy, and others harmonizing treatment by switching to the same ICS/LABA combination used in the on-treatment phase, or a different ICS/LABA combination entirely. Most of the studies included did not report any changes to study outcomes seen prior to randomization. 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.
- Subject
- asthma therapy; asthma outcomes resarch; asthma exacerbations; treatment; SDG 3; Sustainable Development Goal
- Identifier
- http://hdl.handle.net/1959.13/1517501
- Identifier
- uon:57127
- Identifier
- ISSN:2451-8654
- Rights
- X
- Language
- eng
- Reviewed
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