Feasibility Study of the AffloVest in Bronchiectasis
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|ClinicalTrials.gov Identifier: NCT04266873|
Recruitment Status : Suspended (Due to Covid-19 pandemic)
First Posted : February 12, 2020
Last Update Posted : June 27, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Device: AffloVest||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Feasibility interventional study using intervention for 6 weeks|
|Masking:||None (Open Label)|
|Masking Description:||CT scans will be anonymised before being sent to Radiographer to Brody score|
|Official Title:||Measurement of Mucus Plugging With Computer Tomography Before and Following Implementation of the AffloVest in Adults With Bronchiectasis - a Feasibility Study'|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: AffloVest HFCWO intervention
Use of the AffloVest for 30 mins, twice a day for 6 weeks
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
- High Resolution Computed Tomography (HRCT) [ Time Frame: 6 weeks ]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
- Forced Expiratory Volume at 1 second (FEV1) [ Time Frame: 6 weeks ]FEV1, the forced air expelled at 1 second will be measured at baseline, after three weeks intervention and after six weeks intervention
- Visual Analogue Score for ease of sputum expectoration (VAS) [ Time Frame: 6 weeks ]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
- Quality of Life in Bronchiectasis questionnaire (QOL-B) [ Time Frame: 6 weeks ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266873
|Royal Papworth Hospital NHS Trust|
|Cambridge, United Kingdom, CB2 0AY|
Documents provided by Papworth Hospital NHS Foundation Trust:
|Responsible Party:||Papworth Hospital NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||February 12, 2020 Key Record Dates|
|Last Update Posted:||June 27, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||All participant specific data will be anonymised before any data will be published or shared|
|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|
Respiratory Tract Diseases