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Functional Respiratory Imaging in Bronchiectasis (FRIBE)

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ClinicalTrials.gov Identifier: NCT03818646
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Brief Summary:

Four-week prospective single centre exploratory study in adults with bronchiectasis suffering a pulmonary exacerbation (defined as a change in one or more of the following: cough; sputum amount; sputum colour; breathlessness; fevers; and malaise).

The study will recruit ten adult subjects (male and female) who attend the Cambridge Centre for Lung Infection (CCLI) at the Royal Papworth Hospital, Cambridge, United Kingdom. The study will include individuals with a known diagnosis of bronchiectasis suffering a current pulmonary exacerbation. Participants seen during their usual clinic review with an exacerbation will be invited to participate and enrolled to commence the study that same day (day 0). Participants enrolled will undergo clinical review and a series of standard-of-care testing including sputum culture, lung function tests and blood analysis. Additional to these standard investigations, participants will also undertake a series of patient reported outcomes via validated respiratory questionnaires (Quality of Life - Bronchiectasis - QOL-B; & Leicester Cough Questionnaire - LCQ) and functional respiratory imaging (FRI). FRI consists of low dose high-resolution CT at full inspiration and expiration, combined with computational fluid dynamic testing.

Participants will be treated without delay according to standard of care treatment as per current international guidelines. Participants may be treated as either an inpatient or outpatient determined by the treating respiratory physician.

Follow up will occur on day 7, 14 and 28 post enrolment with serial CT imaging on days 0, 14 and 28. No scheduled follow up testing will be required beyond the day 28 visit, however all participants will receive a follow-up phone call at day 35.

The investigators hypothesize that changes in FRI parameters will be seen pre and post exacerbation treatment and will correlate with changes in lung function and patient reported outcomes. This will confirm FRI as a surrogate biomarker for assessing therapeutic response in future clinical trials in bronchiectasis.


Condition or disease Intervention/treatment
Bronchiectasis Diagnostic Test: Functional Respiratory Imaging

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Respiratory Imaging During Pulmonary Exacerbations in Adults With Non-cystic Fibrosis Bronchiectasis
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Functional Respiratory Imaging
    Functional Respiratory Imaging (FRI) is a novel image based functional diagnostic tool that combines high-resolution CT scans (HRCT) at TLC and FRC with flow simulations (computational fluid dynamics - CFD) providing a 3D visualization and quantification of lung structure and function.


Primary Outcome Measures :
  1. Airway volume [ Time Frame: Days 0; 14; and 28 ]
    Change in image based airway volume from FRI

  2. Airway resistance [ Time Frame: Days 0; 14; and 28 ]
    Change in image based airway resistance from FRI

  3. Lung volume [ Time Frame: Days 0; 14; and 28 ]
    Change in image based lung volume from FRI

  4. Internal airflow distribution [ Time Frame: Days 0; 14; and 28 ]
    Change in image based internal airflow distribution from FRI

  5. Airway wall thickness [ Time Frame: Days 0;14; and 28 ]
    Change in image based airway wall thickness from FRI

  6. Blood vessel density [ Time Frame: Days 0; 14; and 28 ]
    Change in image based blood vessel density from FRI

  7. Centreline evaluation (airway dimensions over distance into the lung). [ Time Frame: Days 0; 14; and 28 ]
    Change in image based centreline evaluation (airway dimensions over distance into the lung) from FRI


Secondary Outcome Measures :
  1. Lung function [ Time Frame: Days 0; 14; and 28 ]
    Correlation of FRI to lung function (FEV1)

  2. QOL-B [ Time Frame: Days 0; 14; and 28 ]
    Correlation of FRI to the QOL-B (Quality of Life Bronchiectasis) questionnaire

  3. LCQ [ Time Frame: Days 0; 14; and 28 ]
    Correlation of FRI to the LCQ (Leicester Cough Questionnaire) questionnaire

  4. CRP [ Time Frame: Days 0; 14; and 28 ]
    Correlation of FRI to CRP (C-reactive protein)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study will endeavour to recruit ten adult subjects (male and female) who attend the Cambridge Centre for Lung Infection (CCLI) at the Royal Papworth Hospital, Cambridge, United Kingdom. The study will include individuals with a known diagnosis of bronchiectasis (defined as symptoms of chronic or recurrent bronchial infection with radiological evidence of abnormal and permanent dilation of bronchi) not from cystic fibrosis; and a current pulmonary exacerbation (defined as a 'deterioration in three or more of the following key symptoms for at least 48h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND that a clinician determines a change in bronchiectasis treatment is required).
Criteria

Inclusion Criteria:

  • Adult male and females ≥18 years and ≤ 80 years
  • Current diagnosis of bronchiectasis (see above definition)
  • Current pulmonary exacerbation (see above definition)

Exclusion Criteria:

  • Severe obstructive airways disease (defined as FEV1 < 30%; FEV1/FVC < 70%)
  • Diagnosis of other active chronic lung disease (asthma; ABPA; COPD; pulmonary fibrosis)
  • Currently treated non-tuberculous mycobacterial disease
  • Acute congestive cardiac failure
  • Contra-indication or unable to perform HRCT imaging, including pregnancy
  • Contra-indication or unable to perform pulmonary function testing
  • Active lung malignancy

Information from the National Library of Medicine

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): NCT03818646


Contacts
Contact: Timothy Baird, MBBS 07706229153 tmbaird@gmail.com
Contact: Victoria Stoneman, PhD 0122369865 victoria.stoneman@nhs.net

Locations
United Kingdom
Royal Papworth Hospital NHS Foundation Trust Not yet recruiting
Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Timothy Baird, MBBS    07706229153    tmbaird@gmail.com   
Contact: Victoria Stoneman, PhD    01223639865    victoria.stoneman@nhs.net   
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
Study Director: Ian Smith, MD Royal Papworth Hospital NHS Foundation Trust

Publications:

Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03818646     History of Changes
Other Study ID Numbers: P02470
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Papworth Hospital NHS Foundation Trust:
Exacerbation
Functional respiratory imaging

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases