BronchiectasisNCT04266873
Feasibility Study of the AffloVest in Bronchiectasis
A study testing AffloVest in people with Bronchiectasis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- AffloVest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital NHS Trust
Cambridge, CB2 0AY
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchiectasis
- Being tested
- AffloVest
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AffloVestDevice
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
| Study group | Role | What they receive |
|---|---|---|
| AffloVest HFCWO intervention | Experimental | Use of the AffloVest for 30 mins, twice a day for 6 weeks Receives: Device: AffloVest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Feb 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Data analysis review of current data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility interventional study using intervention for 6 weeks
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266873
- Sponsor's protocol ID
- PO2552
- Status last verified
- May 2025
- First submitted
- 13 Jan 2020
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All participant specific data will be anonymised before any data will be published or shared
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Mucus Plugging With Computer Tomography Before and Following Implementation of the AffloVest in Adults With Bronchiectasis - a Feasibility Study'
- ClinicalTrials.gov ID
- NCT04266873
- Acronym / sponsor ID
- PO2552
- Conditions
- Bronchiectasis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Data analysis review of current data
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility interventional study using intervention for 6 weeks
| Arm | Type | Receives |
|---|---|---|
| AffloVest HFCWO intervention | Experimental | Device: AffloVestUse of the AffloVest for 30 mins, twice a day for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AffloVestForm 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 | Device | AffloVest HFCWO intervention |
Primary outcome
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
3 secondary outcomes
Forced Expiratory Volume at 1 second (FEV1)
Time frame: 6 weeks
Visual Analogue Score for ease of sputum expectoration (VAS)
Time frame: 6 weeks
Quality of Life in Bronchiectasis questionnaire (QOL-B)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No. All participant specific data will be anonymised before any data will be published or shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AffloVest in people with Bronchiectasis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Resolution Computed Tomography (HRCT) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.