Multiple breath washout in bronchiectasis clinical trials: is it feasible?

BACKGROUND

Evaluation of multiple breath washout (MBW) set-up including staff training, certification and central "over-reading" for data quality control is essential to determine the feasibility of MBW in future bronchiectasis studies.

AIMS

To assess the outcomes of a MBW training, certification and central over-reading programme.

METHODS

MBW training and certification was conducted in European sites collecting lung clearance index (LCI) data in the BronchUK Clinimetrics and/or i-BEST-1 studies. The blended training programme included the use of an eLearning tool and a 1-day face-to-face session. Sites submitted MBW data to trained central over-readers who determined validity and quality.

RESULTS

Thirteen training days were delivered to 56 participants from 22 sites. Of 22 sites, 18 (82%) were MBW naïve. Participant knowledge and confidence increased significantly (p<0.001). By the end of the study recruitment, 15 of 22 sites (68%) had completed certification with a mean (range) time since training of 6.2 (3-14) months. In the BronchUK Clinimetrics study, 468 of 589 (79%) tests met the quality criteria following central over-reading, compared with 137 of 236 (58%) tests in the i-BEST-1 study.

CONCLUSIONS

LCI is feasible in a bronchiectasis multicentre clinical trial setting; however, consideration of site experience in terms of training as well as assessment of skill drift and the need for re-training may be important to reduce time to certification and optimise data quality. Longer times to certification, a higher percentage of naïve sites and patients with worse lung function may have contributed to the lower success rate in the i-BEST-1 study.

Informations de copyright

Copyright ©ERS 2020.

Déclaration de conflit d'intérêts

Conflict of interest: K. O'Neill reports grants from European Union IMI (grant agreement number 115721) and Novartis during the conduct of the study. Conflict of interest: K. Ferguson has nothing to disclose. Conflict of interest: D. Cosgrove has nothing to disclose. Conflict of interest: M.M. Tunney reports grants from European Union IMI (grant agreement number 115721) and Novartis during the conduct of the study. Conflict of interest: A. De Soyza reports grants and personal fees from AstraZeneca, medImmune, Insmed, Bayer, Pfizer, GSK, Novartis and Chiesi outside the submitted work. Conflict of interest: M. Carroll has nothing to disclose. Conflict of interest: J.D. Chalmers reports research grants for COPD and personal fees from GlaxoSmithKline and Boehringer Ingelheim, research grants for COPD from AstraZeneca, research grants for COPD and personal fees from Pfizer, research grants for bronchiectasis and personal fees from Bayer Healthcare and Grifols, consulting fees from Napp and the Aradigm Corporation, and grants and personal fees from Insmed, outside the submitted work. Conflict of interest: T. Gatheral has nothing to disclose. Conflict of interest: A.T. Hill has nothing to disclose. Conflict of interest: J.R. Hurst reports grants, personal fees and nonfinancial support from pharmaceutical companies that make medicines to treat bronchiectasis, outside the submitted work. Conflict of interest: C. Johnson has nothing to disclose. Conflict of interest: M.R. Loebinger reports personal fees from AstraZeneca, Grifols and Polyphor outside the submitted work. Conflict of interest: G. Angyalosi reports grants from the IMI Joint Undertaking iABC grant agreement number 115721 and other support from Novartis Pharma AG, during the conduct of the study; and is Novartis Pharma AG employee. Conflict of interest: C.S. Haworth reports an EU-funded IMI grant during the conduct of the study; personal fees from Aradigm, Grifols and Chiesi, grants and personal fees from Insmed, personal fees from Gilead and GSK, collaborated on an IMI grant with Novartis, and grants and personal fees from TEVA, outside the submitted work. Conflict of interest: R. Jensen has nothing to disclose. Conflict of interest: F. Ratjen reports grants and personal fees from Vertex, and personal fees from Novartis, Bayer, Roche and Genetech, outside the submitted work. Conflict of interest: C. Saunders has nothing to disclose. Conflict of interest: C. Short has nothing to disclose. Conflict of interest: J.C. Davies has nothing to disclose. Conflict of interest: J.S. Elborn reports grants from the Framework Seven IMI during the conduct of the study. Conflict of interest: J.M. Bradley has nothing to disclose.