BronchiectasisFRIBENCT03818646
Functional Respiratory Imaging in Bronchiectasis
An observational study of Bronchiectasis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Functional Respiratory Imaging
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2019to Apr 2019
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Adult male and females ≥18 years and ≤ 80 years
- Current diagnosis of bronchiectasis (see above definition)
- Current pulmonary exacerbation (see above definition)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridgeshire, CB23 3RE
Timothy Baird, MBBS, 07706229153, tmbaird@gmail.com
Victoria Stoneman, PhD, 01223639865, victoria.stoneman@nhs.net
About this study
Official title: Functional Respiratory Imaging During Pulmonary Exacerbations in Adults With Non-cystic Fibrosis Bronchiectasis
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.
Read more
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.
Read the detailed description
Four-week prospective single centre exploratory study in adults with bronchiectasis suffering a pulmonary exacerbation.
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).
In order to maximise subject recruitment and understanding of the study, all CCLI patients with bronchiectasis that are known to suffer frequent exacerbations (>2 per year) will be sent details of the trial including the Patient Information and Consent Form at the time of study commencement, prior to their individual enrolment. Subjects then seen during their usual clinic review with a pulmonary 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 testing including pulmonary 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 total lung capacity (TLC) and functional residual capacity (FRC), combined with computational fluid dynamic testing (CFD).
Participants will be treated without delay according to standard usual care as per the current European Respiratory Society (ERS) and British Thoracic Society (BTS) Bronchiectasis Guidelines. Participants may be treated as either an inpatient or outpatient determined by the treating consultant respiratory physician.
Follow up will occur on day 7, 14 and 28 post enrolment. Participants will undergo clinical review and repeat testing according to the below schedule. 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.
Day 0: Initial consultation - presentation with a pulmonary exacerbation
- Recruitment, consent and enrolment
- History and clinical examination
- Bloods (WCC; neutrophil count; CRP)
- Pregnancy test (urine dipstick) - if appropriate
- Lung function testing (FEV1; FVC; TLC)
- Sputum collection
- Functional respiratory imaging (HRCT at TLC and FRC; may occur + 48 hours of enrolment)
- Patient reported outcomes / questionnaires (QOL-B; LCQ)
- Usual treatment commencement (as per current bronchiectasis guidelines)
Day 7: Mid-treatment follow up (as per usual standard of care)
- History and clinical review
- Bloods (WCC, neutrophil count; CRP)
Day 14: End of treatment follow up
- History and clinical examination
- Bloods (WCC; neutrophil count; CRP)
- Pregnancy test (urine dipstick) - if appropriate
- Lung function testing (FEV1; FVC; TLC)
- Functional respiratory imaging (HRCT at TLC and FRC; may occur +/- 48 hours of day 14)
- Patient reported outcomes / questionnaires (QOL-B; LCQ)
Day 28: Completion of study testing
- History and clinical examination
- Bloods (WCC; neutrophil count; CRP)
- Pregnancy test (urine dipstick) - if appropriate
- Lung function testing (FEV1; FVC; TLC)
- Functional respiratory imaging (HRCT at TLC and FRC; may occur +/- 48 hours of day 28)
- Patient reported outcomes (QOL-B; LCQ)
Day 35: Phone call by research team member
- No scheduled investigations
No scheduled follow up testing will be required beyond the day 28 visit other then a follow up phone call at day 35 (see above).
The investigators hypothesize that changes in FRI parameters will be seen pre and post exacerbation treatment and will correlate well 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.
- Conditions
- Bronchiectasis
- Being tested
- Functional Respiratory Imaging
- Keywords
- Exacerbation, Functional respiratory imaging
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Respiratory ImagingDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway volume
Change in image based airway volume from FRI
Measured: Days 0; 14; and 28
Airway resistance
Change in image based airway resistance from FRI
Measured: Days 0; 14; and 28
Lung volume
Change in image based lung volume from FRI
Measured: Days 0; 14; and 28
Internal airflow distribution
Change in image based internal airflow distribution from FRI
Measured: Days 0; 14; and 28
Airway wall thickness
Change in image based airway wall thickness from FRI
Measured: Days 0;14; and 28
Blood vessel density
Change in image based blood vessel density from FRI
Measured: Days 0; 14; and 28
Centreline evaluation (airway dimensions over distance into the lung).
Change in image based centreline evaluation (airway dimensions over distance into the lung) from FRI
Measured: Days 0; 14; and 28
Secondary outcomes (4)
Lung function
Correlation of FRI to lung function (FEV1)
Measured: Days 0; 14; and 28
QOL-B
Correlation of FRI to the QOL-B (Quality of Life Bronchiectasis) questionnaire
Measured: Days 0; 14; and 28
LCQ
Correlation of FRI to the LCQ (Leicester Cough Questionnaire) questionnaire
Measured: Days 0; 14; and 28
CRP
Correlation of FRI to CRP (C-reactive protein)
Measured: Days 0; 14; and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ian Smith, MD, Study director, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818646
- Sponsor's protocol ID
- P02470
- Acronym
- FRIBE
- Status last verified
- Jan 2019
- First submitted
- 29 Nov 2018
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
PubMed 28889110Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.
PubMed 20627931Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
PubMed 28596426Koser U, Hill A. What's new in the management of adult bronchiectasis? F1000Res. 2017 Apr 20;6:527. doi: 10.12688/f1000research.10613.1. eCollection 2017.
PubMed 28491293Quint JK, Millett ER, Joshi M, Navaratnam V, Thomas SL, Hurst JR, Smeeth L, Brown JS. Changes in the incidence, prevalence and mortality of bronchiectasis in the UK from 2004 to 2013: a population-based cohort study. Eur Respir J. 2016 Jan;47(1):186-93. doi: 10.1183/13993003.01033-2015. Epub 2015 Nov 5.
PubMed 26541539Chang AB, Bell SC, Byrnes CA, Grimwood K, Holmes PW, King PT, Kolbe J, Landau LI, Maguire GP, McDonald MI, Reid DW, Thien FC, Torzillo PJ. Chronic suppurative lung disease and bronchiectasis in children and adults in Australia and New Zealand. Med J Aust. 2010 Sep 20;193(6):356-65. doi: 10.5694/j.1326-5377.2010.tb03949.x.
PubMed 20854242Vendrell M, de Gracia J, Olveira C, Martinez-Garcia MA, Giron R, Maiz L, Canton R, Coll R, Escribano A, Sole A. [Diagnosis and treatment of bronchiectasis. Spanish Society of Pneumology and Thoracic Surgery]. Arch Bronconeumol. 2008 Nov;44(11):629-40. doi: 10.1157/13128330. Spanish.
PubMed 19007570Vos W, De Backer J, Poli G, De Volder A, Ghys L, Van Holsbeke C, Vinchurkar S, De Backer L, De Backer W. Novel functional imaging of changes in small airways of patients treated with extrafine beclomethasone/formoterol. Respiration. 2013;86(5):393-401. doi: 10.1159/000347120. Epub 2013 Apr 12.
PubMed 23595105De Backer LA, Vos W, De Backer J, Van Holsbeke C, Vinchurkar S, De Backer W. The acute effect of budesonide/formoterol in COPD: a multi-slice computed tomography and lung function study. Eur Respir J. 2012 Aug;40(2):298-305. doi: 10.1183/09031936.00072511. Epub 2011 Dec 19.
PubMed 22183484Hajian B, De Backer J, Vos W, Van Holsbeke C, Clukers J, De Backer W. Functional respiratory imaging (FRI) for optimizing therapy development and patient care. Expert Rev Respir Med. 2016 Feb;10(2):193-206. doi: 10.1586/17476348.2016.1136216.
PubMed 26731531van Geffen WH, Hajian B, Vos W, De Backer J, Cahn A, Usmani OS, Van Holsbeke C, Pistolesi M, Kerstjens HA, De Backer W. Functional respiratory imaging: heterogeneity of acute exacerbations of COPD. Int J Chron Obstruct Pulmon Dis. 2018 May 30;13:1783-1792. doi: 10.2147/COPD.S152463. eCollection 2018.
PubMed 29881268Bos AC, van Holsbeke C, de Backer JW, van Westreenen M, Janssens HM, Vos WG, Tiddens HA. Patient-specific modeling of regional antibiotic concentration levels in airways of patients with cystic fibrosis: are we dosing high enough? PLoS One. 2015 Mar 3;10(3):e0118454. doi: 10.1371/journal.pone.0118454. eCollection 2015.
PubMed 25734630
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Respiratory Imaging During Pulmonary Exacerbations in Adults With Non-cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT03818646
- Acronym / sponsor ID
- FRIBE / P02470
- Conditions
- Bronchiectasis
- Keywords
- Exacerbation, Functional respiratory imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Jan 2019 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 28 Jan 2019 (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.
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.
Detailed description
Four-week prospective single centre exploratory study in adults with bronchiectasis suffering a pulmonary exacerbation.
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).
In order to maximise subject recruitment and understanding of the study, all CCLI patients with bronchiectasis that are known to suffer frequent exacerbations (>2 per year) will be sent details of the trial including the Patient Information and Consent Form at the time of study commencement, prior to their individual enrolment. Subjects then seen during their usual clinic review with a pulmonary 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 testing including pulmonary 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 total lung capacity (TLC) and functional residual capacity (FRC), combined with computational fluid dynamic testing (CFD).
Participants will be treated without delay according to standard usual care as per the current European Respiratory Society (ERS) and British Thoracic Society (BTS) Bronchiectasis Guidelines. Participants may be treated as either an inpatient or outpatient determined by the treating consultant respiratory physician.
Follow up will occur on day 7, 14 and 28 post enrolment. Participants will undergo clinical review and repeat testing according to the below schedule. 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.
Day 0: Initial consultation - presentation with a pulmonary exacerbation
- Recruitment, consent and enrolment
- History and clinical examination
- Bloods (WCC; neutrophil count; CRP)
- Pregnancy test (urine dipstick) - if appropriate
- Lung function testing (FEV1; FVC; TLC)
- Sputum collection
- Functional respiratory imaging (HRCT at TLC and FRC; may occur + 48 hours of enrolment)
- Patient reported outcomes / questionnaires (QOL-B; LCQ)
- Usual treatment commencement (as per current bronchiectasis guidelines)
Day 7: Mid-treatment follow up (as per usual standard of care)
- History and clinical review
- Bloods (WCC, neutrophil count; CRP)
Day 14: End of treatment follow up
- History and clinical examination
- Bloods (WCC; neutrophil count; CRP)
- Pregnancy test (urine dipstick) - if appropriate
- Lung function testing (FEV1; FVC; TLC)
- Functional respiratory imaging (HRCT at TLC and FRC; may occur +/- 48 hours of day 14)
- Patient reported outcomes / questionnaires (QOL-B; LCQ)
Day 28: Completion of study testing
- History and clinical examination
- Bloods (WCC; neutrophil count; CRP)
- Pregnancy test (urine dipstick) - if appropriate
- Lung function testing (FEV1; FVC; TLC)
- Functional respiratory imaging (HRCT at TLC and FRC; may occur +/- 48 hours of day 28)
- Patient reported outcomes (QOL-B; LCQ)
Day 35: Phone call by research team member
- No scheduled investigations
No scheduled follow up testing will be required beyond the day 28 visit other then a follow up phone call at day 35 (see above).
The investigators hypothesize that changes in FRI parameters will be seen pre and post exacerbation treatment and will correlate well 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Adult male and females ≥18 years and ≤ 80 years
- Current diagnosis of bronchiectasis (see above definition)
- Current pulmonary exacerbation (see above definition)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Functional Respiratory ImagingFunctional 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. | Diagnostic test | – |
Primary outcome
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
4 secondary outcomes
Lung function
Time frame: Days 0; 14; and 28
QOL-B
Time frame: Days 0; 14; and 28
LCQ
Time frame: Days 0; 14; and 28
CRP
Time frame: Days 0; 14; and 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Background: PubMed 28889110Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
- Background: PubMed 20627931Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.
- Background: PubMed 28596426Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
- Background: PubMed 28491293Koser U, Hill A. What's new in the management of adult bronchiectasis? F1000Res. 2017 Apr 20;6:527. doi: 10.12688/f1000research.10613.1. eCollection 2017.
- Background: PubMed 26541539Quint JK, Millett ER, Joshi M, Navaratnam V, Thomas SL, Hurst JR, Smeeth L, Brown JS. Changes in the incidence, prevalence and mortality of bronchiectasis in the UK from 2004 to 2013: a population-based cohort study. Eur Respir J. 2016 Jan;47(1):186-93. doi: 10.1183/13993003.01033-2015. Epub 2015 Nov 5.
- Background: PubMed 20854242Chang AB, Bell SC, Byrnes CA, Grimwood K, Holmes PW, King PT, Kolbe J, Landau LI, Maguire GP, McDonald MI, Reid DW, Thien FC, Torzillo PJ. Chronic suppurative lung disease and bronchiectasis in children and adults in Australia and New Zealand. Med J Aust. 2010 Sep 20;193(6):356-65. doi: 10.5694/j.1326-5377.2010.tb03949.x.
- Background: PubMed 19007570Vendrell M, de Gracia J, Olveira C, Martinez-Garcia MA, Giron R, Maiz L, Canton R, Coll R, Escribano A, Sole A. [Diagnosis and treatment of bronchiectasis. Spanish Society of Pneumology and Thoracic Surgery]. Arch Bronconeumol. 2008 Nov;44(11):629-40. doi: 10.1157/13128330. Spanish.
- Background: PubMed 23595105Vos W, De Backer J, Poli G, De Volder A, Ghys L, Van Holsbeke C, Vinchurkar S, De Backer L, De Backer W. Novel functional imaging of changes in small airways of patients treated with extrafine beclomethasone/formoterol. Respiration. 2013;86(5):393-401. doi: 10.1159/000347120. Epub 2013 Apr 12.
- Background: PubMed 22183484De Backer LA, Vos W, De Backer J, Van Holsbeke C, Vinchurkar S, De Backer W. The acute effect of budesonide/formoterol in COPD: a multi-slice computed tomography and lung function study. Eur Respir J. 2012 Aug;40(2):298-305. doi: 10.1183/09031936.00072511. Epub 2011 Dec 19.
- Background: PubMed 26731531Hajian B, De Backer J, Vos W, Van Holsbeke C, Clukers J, De Backer W. Functional respiratory imaging (FRI) for optimizing therapy development and patient care. Expert Rev Respir Med. 2016 Feb;10(2):193-206. doi: 10.1586/17476348.2016.1136216.
- Background: PubMed 29881268van Geffen WH, Hajian B, Vos W, De Backer J, Cahn A, Usmani OS, Van Holsbeke C, Pistolesi M, Kerstjens HA, De Backer W. Functional respiratory imaging: heterogeneity of acute exacerbations of COPD. Int J Chron Obstruct Pulmon Dis. 2018 May 30;13:1783-1792. doi: 10.2147/COPD.S152463. eCollection 2018.
- Background: PubMed 25734630Bos AC, van Holsbeke C, de Backer JW, van Westreenen M, Janssens HM, Vos WG, Tiddens HA. Patient-specific modeling of regional antibiotic concentration levels in airways of patients with cystic fibrosis: are we dosing high enough? PLoS One. 2015 Mar 3;10(3):e0118454. doi: 10.1371/journal.pone.0118454. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Ian Smith, MD study director
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Jan 2019. 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?
Contact Timothy Baird, MBBS (07706229153, tmbaird@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway volume (time frame: Days 0; 14; and 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818646, which also lists 12 linked publications.
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 28 Jan 2019.