NCT04266873

Feasibility Study of the AffloVest in Bronchiectasis

Measurement of Mucus Plugging With Computer Tomography Before and Following Implementation of the AffloVest in Adults With Bronchiectasis - a Feasibility Study'

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Papworth Hospital NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Feasibility study of High Frequency Chest Wall Oscillation (HFCWO) using the AffloVest in 30 patients with Bronchiectasis over a 6 week period. Outcome measures include lung function, quality of life questionnaire, High resolution computed Tomography and visual analogue scale for ease of clearance.

Detailed description

The study is an feasibility study evaluating the impact of using the AffloVest for 30 minutes twice daily \[in addition to their standard airway clearance regimen\] for 6 weeks. The study will endeavour to 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 will use the AffloVest for 30 minutes twice dally \[in addition to their standard airway clearance regimen\] for 6 weeks (days 0 - 42). Clinical review and a serial testing will be completed at day1, day 21 and day 42 (at commencement of intervention, after 3 weeks intervention and after 6 weeks intervention) including high resolution computer tomography (HRCT) at full inspiration and full expiration; 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). HRCT imaging will be done at full inspiration and full expiration and scored by two independent expert thoracic radiologists using the validated Brody Scoring System which is sensitive and reproducible. Both will be blinded to the timepoint of the HRCT being analysed and if there is disagreement in scores an average will be taken. We hypothesize that changes in HRCT score and patient reported outcomes will be seen post treatment with the AffloVest, confirming it as an efficacious therapy for airway clearance in adults with bronchiectasis.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DEVICE	AffloVest	Form of High Frequency Chest Wall Oscillation mimicking manual techniques on a patients thorax to assist with secretion clearance. Delivered for 30 minutes, twice a day

Timeline

• Start date: 2020-02-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2020-02-12
• Last updated: 2025-05-31

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study