Feasibility Study of the AffloVest in Bronchiectasis

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Bronchiectasis
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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

, ,

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

, ,

Verification Date

March 2020