Brief Title
Feasibility Study of the AffloVest in Bronchiectasis
Official Title
Measurement of Mucus Plugging With Computer Tomography Before and Following Implementation of the AffloVest in Adults With Bronchiectasis - a Feasibility Study'
Brief 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.
Study Type
Interventional
Primary Outcome
High Resolution Computed Tomography (HRCT)
Secondary Outcome
Forced Expiratory Volume at 1 second (FEV1)
Condition
Bronchiectasis
Intervention
AffloVest
Study Arms / Comparison Groups
AffloVest HFCWO intervention
Description: Use of the AffloVest for 30 mins, twice a day for 6 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
February 1, 2020
Completion Date
December 31, 2020
Primary Completion Date
August 31, 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04266873
Organization ID
PO2552
Responsible Party
Sponsor
Study Sponsor
Papworth Hospital NHS Foundation Trust
Study Sponsor
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Verification Date
March 2020