Clinical trial NCT04266873: 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'
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Bronchiectasis
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility interventional study using intervention for 6 weeks
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: High Resolution Computed Tomography (HRCT)
timeFrame: 6 weeks
Secondary outcomes:
measure: Forced Expiratory Volume at 1 second (FEV1)
timeFrame: 6 weeks
measure: Visual Analogue Score for ease of sputum expectoration (VAS)
timeFrame: 6 weeks
measure: Quality of Life in Bronchiectasis questionnaire (QOL-B)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Trust
Study officials:
References: