Status:
COMPLETED
Target Validation and Discovery in Idiopathic Bronchiectasis
Lead Sponsor:
Papworth Hospital NHS Foundation Trust
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Bronchiectasis
Idiopathic Bronchiectasis
Eligibility:
All Genders
18-80 years
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 9 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03750734
Start Date
September 10 2019
End Date
August 9 2021
Last Update
April 4 2022
Active Locations (1)
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1
Royal Papworth Hospital
Cambridge, United Kingdom