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. 2020 Oct;7(1):e000694.
doi: 10.1136/bmjresp-2020-000694.

Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial

Gemma Stanford  1   2 , Jane C Davies  2   3 , Omar Usmani  2   4 , Winston Banya  2   4 , Susan Charman  5 , Mandy Jones  6 , Nicholas J Simmonds  7   2 , Diana Bilton  8
Affiliations

Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial

Gemma Stanford et al. BMJ Open Respir Res. 2020 Oct.

Abstract

Introduction: Airway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.

Methods and analysis: This is a single-centre RCT with crossover design. Participants perform MBW, IOS and spirometry, and then are randomised to either rest or supervised ACT lasting 30-60 min. MBW, IOS and spirometry are repeated immediately afterwards. EIT and sputum are collected during rest/ACT. On a separate day, the OMs are performed with the other intervention. Primary endpoint is difference in change in OMs before and after ACT/rest. Sample size was calculated with 80% power and significance of 5% for each OM (target n=64).

Ethics and dissemination: Ethics approval was gained from the London-Chelsea Research Ethics Committee (reference 16/LO/0995, project ID 154635). Dissemination will involve scientific conference presentation and publication in a peer-reviewed journal.

Trial registration numbers: ISRCTN11220163 and NCT02721498.

Keywords: cystic fibrosis; respiratory measurement.

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Conflict of interest statement

Competing interests: JD reports other from Algipharma AS; Bayer AG; Boehringer Ingelheim Pharma GmbH & Co. KG; Galapagos NV; ImevaX GmbH; Nivalis Therapeutics; ProQR Therapeutics III B.V.; Proteostasis Therapeutics; Raptor Pharmaceuticals; Vertex Pharmaceuticals (Europe) Limited; Enterprise; Novartis; Pulmocide; Flatley; Teva and grants from CF Trust outside the submitted work. NJS reports personal fees from Vertex; Chiesi; Teva; Roche; Pulmocide and Zambon outside the submitted work.

Figures

Figure 1
Figure 1
Schematic of trial design. Diagram illustrating the research journey for a trial participant, from their recruitment and giving of informed consent to completing study day one: baseline outcome measures (OMs) followed by randomisation to intervention (rest or airway clearance therapy (ACT)) and postintervention OMs. The time gap in-between visits should be no longer than 3 months. On study day 2, the participant completes the same OMs before and after the other intervention. Participation in the study is then complete.
Figure 2
Figure 2
Flow diagram of a study visit. CF, cystic fibrosis, EIT, electrical impedance tomography; ISO, impulse oscillometry; MBW, multiple breath washout.
Figure 3
Figure 3
The active cycle of breathing techniques (adapted from the International Physiotherapy Group-Cystic Fibrosis (IPG/CF) Blue Booklet, 201944).
See this image and copyright information in PMC

References

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    1. ACPCF CF Trust Factsheet - Physiotherapy treatment in cystic fibrosis: airway clearance techniques, 2013.

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