BronchiectasisNCT03750734
Target Validation and Discovery in Idiopathic Bronchiectasis
An observational study of Bronchiectasis and Idiopathic Bronchiectasis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis, Idiopathic Bronchiectasis
- What is being tested?
- Bronchoscopy and Blood test
- Type of treatment
- Injection or infusion
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2019to 9 Aug 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Secondary care respiratory clinics
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Bronchiectasis, Idiopathic Bronchiectasis
- Being tested
- Bronchoscopy, Blood test
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyDiagnostic test
Flexible bronchoscopy will be performed under sedation (typically a sedative such as intravenous midazolam and/or fentanyl) with local anaesthetic to the throat and vocal cords. Bronchial epithelial tissue (via bronchial brushing and biopsy forceps) and bronchial lavage samples will be taken for analysis.
Blood testDiagnostic test
Peripheral blood will be taken to collect peripheral blood monocytes, which will then allow the production of induced pluripotent stem cell derived bronchial epithelial tissues.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic bronchiectasis | Idiopathic bronchiectasis participants Receives: Diagnostic Test: Bronchoscopy; Diagnostic Test: Blood test | |
| Healthy volunteers | Healthy volunteers Receives: Diagnostic Test: Bronchoscopy; Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and comparison of molecular pathways, including through gene expression analysis of airway tissues.
Identification and comparison of molecular pathways, including through gene expression analysis of airway tissues.
Measured: 2 years
Secondary outcomes (2)
Generation of air liquid interface cultures from primary bronchial epithelial cells/IPSC derived bronchial epithelial cells
Generation of air liquid interface cultures from primary bronchial epithelial cells/IPSC derived bronchial epithelial cells
Measured: 2 years
Functional characterisation of airway epithelium
Functional characterisation of airway epithelium
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start10 Sep 2019
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Dr W Flowers, Principal investigator, Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750734
- Sponsor's protocol ID
- P02437
- Status last verified
- Mar 2022
- First submitted
- 20 Nov 2018
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Validation and Discovery in Idiopathic Bronchiectasis
- ClinicalTrials.gov ID
- NCT03750734
- Acronym / sponsor ID
- P02437
- Conditions
- Bronchiectasis, Idiopathic Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- GlaxoSmithKline
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 23 Nov 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic bronchiectasis | – | Diagnostic Test: Bronchoscopy, Diagnostic Test: Blood testIdiopathic bronchiectasis participants |
| Healthy volunteers | – | Diagnostic Test: Bronchoscopy, Diagnostic Test: Blood testHealthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care respiratory clinics
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| BronchoscopyFlexible bronchoscopy will be performed under sedation (typically a sedative such as intravenous midazolam and/or fentanyl) with local anaesthetic to the throat and vocal cords. Bronchial epithelial tissue (via bronchial brushing and biopsy forceps) and bronchial lavage samples will be taken for analysis. | Diagnostic test | Healthy volunteers, Idiopathic bronchiectasis |
| Blood testPeripheral blood will be taken to collect peripheral blood monocytes, which will then allow the production of induced pluripotent stem cell derived bronchial epithelial tissues. | Diagnostic test | Healthy volunteers, Idiopathic bronchiectasis |
Primary outcome
Identification and comparison of molecular pathways, including through gene expression analysis of airway tissues.
Time frame: 2 years
Identification and comparison of molecular pathways, including through gene expression analysis of airway tissues.
2 secondary outcomes
Generation of air liquid interface cultures from primary bronchial epithelial cells/IPSC derived bronchial epithelial cells
Time frame: 2 years
Functional characterisation of airway epithelium
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- 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.
Dr W Flowers principal investigator
Royal Papworth Hospital
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 and Idiopathic 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 16 inclusion and 13 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: finished, as of the sponsor's last update on 4 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and comparison of molecular pathways, including through gene expression analysis of airway tissues. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2022.