Feasibility study of the AffloVest in Bronchiectasis
Research type
Research Study
Full title
Measurement of mucus plugging with computer tomography before and following implementation of the AffloVest in adults with bronchiectasis - a feasibility study.
IRAS ID
257616
Contact name
Charles Haworth
Contact email
Sponsor organisation
Royal Papworth Hospital NHS Trust
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
This is a feasibility study using computer tomography (CT scans) to measure the amount of mucus plugging within the lungs of adults with bronchiectasis before and following implementation of the AffloVest. The aims of the study include assessing the feasibility of the protocol and estimating the size and variability of the treatment effect with the AffloVest to facilitate the design of a future study to test treatment efficacy.
The study will recruit 30 adult subjects (male and female) who have a known diagnosis of bronchiectasis and who attend the Cambridge Centre for Lung Infection (CCLI) at the Royal Papworth Hospital, Cambridge, United Kingdom. Bronchiectasis is defined as symptoms of chronic or recurrent bronchial infection with radiological evidence of abnormal and permanent dilation of bronchi, not from cystic fibrosis.
Subjects will be recruited through convenience sampling and must demonstrate stability during a 2 week period prior to enrolment. Stability is defined as no change in medical treatment.
Participants enrolled will commence 6 weeks of AffloVest twice daily for 30 minutes, in addition to their standard chest clearance where possible (days 0 – 42). Clinical review and testing at day 0, day 21 and day 42 will occur and include computer tomography (CT); spirometry (FEV1 and FVC); and the patient reported outcomes (Visual Analogue Scale for ease of sputum clearance (VAS), St George's Respiratory Questionnaire (SGRQ) and Quality of Life – Bronchiectasis (QOL-B)).
CT imaging will be scored by two independent expert thoracic radiologists using the validated modified Brody Scoring System. The radiologists will be blinded to the timepoint of the scan. The two scores will be averaged.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0242
Date of REC Opinion
11 Nov 2019
REC opinion
Further Information Favourable Opinion