Target Validation and Discovery in Idiopathic Bronchiectasis

  • STATUS
    Recruiting
  • End date
    Jan 24, 2022
  • participants needed
    50
  • sponsor
    Papworth Hospital NHS Foundation Trust
Updated on 24 January 2021
COPD
pulmonary disease
cystic fibrosis
asthma
fibrosis
emphysema
bronchoscopy

Summary

Bronchiectasis is a long-term lung condition where the airways become abnormally enlarged, leading to a build-up of mucus and inflammation that makes the lungs more susceptible to recurrent infection. Patients with bronchiectasis have subtle abnormalities in the way their airway cells respond to infection that are, in part, responsible for the development of their condition. At present there are no licensed treatments for bronchiectasis.

This study will aim to characterise in depth some of these abnormalities with a view to future studies that will try to develop treatments that can directly target those abnormalities at a molecular level.

Patients known to have bronchiectasis who have provided written informed consent will be enrolled alongside healthy volunteers and patients with chronic obstructive pulmonary disease and cystic fibrosis, for comparison. Participants will give a blood sample and have a bronchoscopy. This is a thin telescopic tube, passed through the nose or mouth, under sedation, into the airways that will allow a sample of bronchial epithelial cells to be taken.

The main objective of the study is to achieve a greater understanding of some of the key biological processes/pathways and disease marker genes that play a role in the development of bronchiectasis. This is important because, at present, little is known about the underlying disease mechanisms and there are no licensed treatments for bronchiectasis.

The investigator's hope this in-depth characterisation of specific bronchial epithelial cell abnormalities in bronchiectasis will shed light on novel targets for future drug discovery.

Details
Condition Bronchiectasis, Idiopathic Bronchiectasis
Treatment Bronchoscopy, Blood test
Clinical Study IdentifierNCT03750734
SponsorPapworth Hospital NHS Foundation Trust
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Bronchiectasis participants
Confirmed HRCT diagnosis of bronchiectasis in more than 1 lobe
Bronchiectasis not attributable to another cause, e.g. cystic fibrosis/ABPA/PCD
Absence of significant emphysema, COPD or asthma
Have provided written informed consent that they are willing to participate in the study prior to sample collection
COPD participants (disease controls)
Confirmed diagnosis of COPD according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria (FEV1/FVC ratio < 0.70)
Absence of significant bronchiectasis on HRCT
Have provided written informed consent that they are willing to participate in the study prior to sample collection
Cystic fibrosis participants (disease controls)
Have a confirmed diagnosis of cystic fibrosis
Have provided written informed consent that they are willing to participate in the study prior to sample collection
Healthy controls
No history or diagnosis of clinically significant lung disease
Be a non-smoker for > 1 year at screening and have < 5 pack year history of smoking
Have provided written informed consent that they are willing to participate in the study prior to sample collection

Exclusion Criteria

Any clinically significant acute illness, including recent exacerbation of lung disease requiring treatment with oral or intravenous antibiotics, in 6 weeks prior to screening
Any contraindication to safe bronchoscopy as judged by CI or clinical team (FEV1 < 30% predicted, oxygen saturations < 92% on room air etc.)
Any clinically significant bleeding disorder or use of anticoagulant/antiplatelet therapy that could place participants at risk of bleeding
Any contraindication to sedation or local anaesthetic medications used for bronchoscopy
Current smoking within 6 months prior to screening (defined as someone who has smoked at least one cigarette per day (or pipe, cigar, or cannabis) for 30 days within 6 months prior to screening)
Acute MI, acute stroke or major surgery within 6 months prior to screening
History of uncontrolled ischaemic heart disease that place participants at risk during bronchoscopy
History of ventilatory failure or hypercapnia that may complicate bronchoscopy
Any known active tuberculous or non-tuberculous mycobacterial infection
Any use of oral corticosteroids within 4 weeks of screening
Any systemic immunomodulatory or immunosuppressive therapy within 3 months of screening
Known current malignancy or current evaluation for a potential malignancy
Any other clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigators, to impact the patient's ability to safely participate in the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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