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'

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.

Study Overview

• Status: Suspended
• Conditions: Bronchiectasis
• Intervention / Treatment: Device: AffloVest

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Royal Papworth Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult male and females 18 years or over
• Current diagnosis of bronchiectasis
• Productive of sputum on a daily basis
• Clinical stability over a 2 week period prior to enrolment

Exclusion Criteria:

• Cystic fibrosis
• Severe obstructive airways disease (defined as FEV1 less than 25 percent)
• Predominant lung disease is not bronchiectasis in the opinion of the investigator (e.g. asthma, Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis)
• Bronchiectasis in only 1 lobe
• Currently treated non-tuberculous mycobacterial lung disease
• Acute congestive cardiac failure
• Contra-indication or unable to perform HRCT imaging, including pregnancy
• Contra-indication to using AffloVest including lung malignancy, recent rib fractures, radiological evidence of lung cavitation, and recent significant haemoptysis (in the opinion of the investigator)
• History of poor adherence to physiotherapy treatment
• Cognitive or memory problems affecting ability to follow instructions or give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AffloVest HFCWO intervention; Use of the AffloVest for 30 mins, twice a day for 6 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Resolution Computed Tomography (HRCT)	HRCT will be done at full inspiration and full expiration and reviewed by two independent radiographers who will be blinded to timepoint and participant. Radiographers will then use the Brody score to give the scans a score reflecting any changes to sputum volume or otherwise from intervention. Scans will be done and reviewed at baseline, three weeks of intervention and six weeks of intervention	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume at 1 second (FEV1)	FEV1, the forced air expelled at 1 second will be measured at baseline, after three weeks intervention and after six weeks intervention	6 weeks
Visual Analogue Score for ease of sputum expectoration (VAS)	A likert scale from 0-10 will be used for participants to score how easy it is for them to expectorate. Again, this will be assessed at baseline, after 3 weeks intervention and after 6 weeks intervention. 0 will be very easy to clear and 10 will be very difficult to clear	6 weeks
Quality of Life in Bronchiectasis questionnaire (QOL-B)	This subjective questionnaire will be completed as baseline, after three weeks intervention and after six weeks intervention. This is completed by the patient to assess how symptoms affect the quality of their lives. Final scores will be between 0 and 100 with higher scores representing better quality of life.	6 weeks

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: PO2552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All participant specific data will be anonymised before any data will be published or shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes