Functional Respiratory Imaging in Bronchiectasis

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Brief Title

Functional Respiratory Imaging in Bronchiectasis

Official Title

Functional Respiratory Imaging During Pulmonary Exacerbations in Adults With Non-cystic Fibrosis Bronchiectasis

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.
    

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 Type

Observational


Primary Outcome

Airway volume

Secondary Outcome

 Lung function

Condition

Bronchiectasis

Intervention

Functional Respiratory Imaging


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

Diagnostic Test

Estimated Enrollment

10

Start Date

January 2019

Completion Date

April 2019

Primary Completion Date

April 2019

Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years


Contacts

Ian Smith, MD, 07706229153, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03818646

Organization ID

P02470


Responsible Party

Sponsor

Study Sponsor

Papworth Hospital NHS Foundation Trust


Study Sponsor

Ian Smith, MD, Study Director, Royal Papworth Hospital NHS Foundation Trust


Verification Date

January 2019