Functional Respiratory Imaging in Bronchiectasis

NCT03818646 | Unknown

• 1 other identifier: P02470
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Exacerbation; Functional respiratory imaging

Outcome Measures

Primary Outcomes (7)

• Airway volume

  Change in image based airway volume from FRI

  Days 0; 14; and 28

• Airway resistance

  Change in image based airway resistance from FRI

  Days 0; 14; and 28

• Lung volume

  Change in image based lung volume from FRI

  Days 0; 14; and 28

• Internal airflow distribution

  Change in image based internal airflow distribution from FRI

  Days 0; 14; and 28

• Airway wall thickness

  Change in image based airway wall thickness from FRI

  Days 0;14; and 28

• Blood vessel density

  Change in image based blood vessel density from FRI

  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

  Days 0; 14; and 28

Secondary Outcomes (4)

• Lung function

  Days 0; 14; and 28

• QOL-B

  Days 0; 14; and 28

• LCQ

  Days 0; 14; and 28

• CRP

  Days 0; 14; and 28

Interventions

Functional Respiratory Imaging DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Papworth Everard, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 28889110 BACKGROUND

• Pasteur 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.

  PMID: 20627931 BACKGROUND

• Hill 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.

  PMID: 28596426 BACKGROUND

• Koser 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.

  PMID: 28491293 BACKGROUND

• Quint 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.

  PMID: 26541539 BACKGROUND

• Chang 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.

  PMID: 20854242 BACKGROUND

• Vendrell 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.

  PMID: 19007570 BACKGROUND

• Vos 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.

  PMID: 23595105 BACKGROUND

• De 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.

  PMID: 22183484 BACKGROUND

• Hajian 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.

  PMID: 26731531 BACKGROUND

• van 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.

  PMID: 29881268 BACKGROUND

• Bos 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.

  PMID: 25734630 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Ian Smith, MD

  Royal Papworth Hospital NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Timothy Baird, MBBS

CONTACT

07706229153; tmbaird@gmail.com

Victoria Stoneman, PhD

CONTACT

0122369865; victoria.stoneman@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: January 28, 2019
• Study Start: January 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)