Functional Respiratory Imaging in Bronchiectasis (FRIBE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03818646|
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
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|
|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|
- 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.
- Airway volume [ Time Frame: Days 0; 14; and 28 ]Change in image based airway volume from FRI
- Airway resistance [ Time Frame: Days 0; 14; and 28 ]Change in image based airway resistance from FRI
- Lung volume [ Time Frame: Days 0; 14; and 28 ]Change in image based lung volume from FRI
- Internal airflow distribution [ Time Frame: Days 0; 14; and 28 ]Change in image based internal airflow distribution from FRI
- Airway wall thickness [ Time Frame: Days 0;14; and 28 ]Change in image based airway wall thickness from FRI
- Blood vessel density [ Time Frame: Days 0; 14; and 28 ]Change in image based blood vessel density from FRI
- 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
- Lung function [ Time Frame: Days 0; 14; and 28 ]Correlation of FRI to lung function (FEV1)
- QOL-B [ Time Frame: Days 0; 14; and 28 ]Correlation of FRI to the QOL-B (Quality of Life Bronchiectasis) questionnaire
- LCQ [ Time Frame: Days 0; 14; and 28 ]Correlation of FRI to the LCQ (Leicester Cough Questionnaire) questionnaire
- CRP [ Time Frame: Days 0; 14; and 28 ]Correlation of FRI to CRP (C-reactive protein)
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
|Contact: Timothy Baird, MBBSfirstname.lastname@example.org|
|Contact: Victoria Stoneman, PhDemail@example.com|
|Royal Papworth Hospital NHS Foundation Trust||Not yet recruiting|
|Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE|
|Contact: Timothy Baird, MBBS 07706229153 firstname.lastname@example.org|
|Contact: Victoria Stoneman, PhD 01223639865 email@example.com|
|Study Director:||Ian Smith, MD||Royal Papworth Hospital NHS Foundation Trust|