Feasibility Study of the AffloVest in Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04266873
• Other study ID #: PO2552
• Status: Suspended
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital NHS Trust	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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