Healthy ChildrenLUCI-EDNCT05989360
The Utility of Lung Clearance Index in Ethnic Groups and in Disease
A study testing Lung Clearance Index in people with Healthy Children and Bronchiectasis Adult, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Introduction: Non-CF, non-PCD bronchiectasis in children is a chronic, suppurative lung disease diagnosed by high resolution computed tomography (HRCT) imaging of the lungs. Spirometry can be abnormal in bronchiectasis but has been shown to be insensitive to early disease in other related conditions such as cystic… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children, Bronchiectasis Adult, Lung Clearance Index
- What is being tested?
- Lung Clearance Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2020to 1 Sep 2022
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children
Who cannot join
- Those with underlying respiratory/systemic disease/ prematurity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Children's Hospital
Birmingham, West Midlands, B4 6NH
About this study
Introduction:
Non-CF, non-PCD bronchiectasis in children is a chronic, suppurative lung disease diagnosed by high resolution computed tomography (HRCT) imaging of the lungs. Spirometry can be abnormal in bronchiectasis but has been shown to be insensitive to early disease in other related conditions such as cystic fibrosis. Lung clearance index (LCI) could have a role in assessment of the disease.
Read more
Lung clearance index is calculated from multiple breath washout tests. There are limited data on the normative values expected using some devices, in a range of ages, and between ethnic groups.
The investigators aim to establish normative values in children aged between 6 years and 12 years, to investigate differences between ethnic groups, and to establish the relationship between lung clearance index and other measures of disease in children with bronchiectasis.
Methods:
Healthy children will be recruited from a range of settings and reviewed to ensure no previous lung disease. Children with bronchiectasis diagnosed on HRCT will be recruited from the outpatient service of Birmingham Children's Hospital.
All participants will perform lung function tests including LCI and spirometry. Basic demographic data was collected.
Read the detailed description
Rationale / Hypothesis:
Hypothesis 1
Having established normative ranges helps support interpretation of lung function testing which is key to their value as an investigation. With LCI, it is important to understand the difference that may be expected between children
of different ethnic backgrounds (as demonstrated with other, non-LCI measures of lung function, where important differences between different ethnic groups has been found).
LCI is calculated from an internally adjusted measure of an individual subject's lung volume, therefore potentially negating inherent differences in ethnic variation.
Therefore we hypothesize that there are no differences in LCI in healthy children from differing ethnic backgrounds.
Evidence supporting this hypothesis is not only of intellectual value, but it would also allow clinicians to confidently interpret a range of LCI readings using globally acquired normal values. Should the data not support the hypothesis, an important direction for future research would be established.
Hypothesis 2
LCI has been demonstrated to detect small differences in lung function and correlates well with CT imaging in some disease states. There is a paucity of data in its use in its lung disease outside of CF. Current availability of easy to use, repeatable and reliable devices allows LCI to be measured in the clinic setting (Downing et al. 2016).
Understanding the relationship between CT changes and LCI in younger children with lung disease, would allow a non-invasive investigation (LCI) to be used to guide care and monitor treatment.
In order to understand how LCI changes, we also intend to determine how LCI varies in children with Non-CF, Non-PCD Bronchiectasis over a prolonged period of time.
The investigators hypothesize that in younger children with Non-CF, Non-PCD Bronchiectasis and evidence of milder disease on CT, LCI is a more sensitive disease marker than FEV1, and varies over time.
- Conditions
- Healthy Children, Bronchiectasis Adult, Lung Clearance Index
- Being tested
- Lung Clearance Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Clearance IndexDiagnostic test
Normative values in healthy children from ethnic backgrounds
| Study group | Role | What they receive |
|---|---|---|
| observational | Experimental | Not described Receives: Diagnostic Test: Lung Clearance Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative values in healthy children
The normative range of measurements of lung clearance index will be determined
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start11 Mar 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prasad Nagakumar, MD, Principal investigator, Birmingham Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989360
- Sponsor's protocol ID
- 273069
- Acronym
- LUCI-ED
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 14 Aug 2023
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Lung Clearance Index in Ethnic Groups and in Disease
- ClinicalTrials.gov ID
- NCT05989360
- Acronym / sponsor ID
- LUCI-ED / 273069
- Conditions
- Healthy Children, Bronchiectasis Adult, Lung Clearance Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 14 Aug 2023 (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.
Introduction:
Non-CF, non-PCD bronchiectasis in children is a chronic, suppurative lung disease diagnosed by high resolution computed tomography (HRCT) imaging of the lungs. Spirometry can be abnormal in bronchiectasis but has been shown to be insensitive to early disease in other related conditions such as cystic fibrosis. Lung clearance index (LCI) could have a role in assessment of the disease.
Lung clearance index is calculated from multiple breath washout tests. There are limited data on the normative values expected using some devices, in a range of ages, and between ethnic groups.
The investigators aim to establish normative values in children aged between 6 years and 12 years, to investigate differences between ethnic groups, and to establish the relationship between lung clearance index and other measures of disease in children with bronchiectasis.
Methods:
Healthy children will be recruited from a range of settings and reviewed to ensure no previous lung disease. Children with bronchiectasis diagnosed on HRCT will be recruited from the outpatient service of Birmingham Children's Hospital.
All participants will perform lung function tests including LCI and spirometry. Basic demographic data was collected.
Detailed description
Rationale / Hypothesis:
Hypothesis 1
Having established normative ranges helps support interpretation of lung function testing which is key to their value as an investigation. With LCI, it is important to understand the difference that may be expected between children
of different ethnic backgrounds (as demonstrated with other, non-LCI measures of lung function, where important differences between different ethnic groups has been found).
LCI is calculated from an internally adjusted measure of an individual subject's lung volume, therefore potentially negating inherent differences in ethnic variation.
Therefore we hypothesize that there are no differences in LCI in healthy children from differing ethnic backgrounds.
Evidence supporting this hypothesis is not only of intellectual value, but it would also allow clinicians to confidently interpret a range of LCI readings using globally acquired normal values. Should the data not support the hypothesis, an important direction for future research would be established.
Hypothesis 2
LCI has been demonstrated to detect small differences in lung function and correlates well with CT imaging in some disease states. There is a paucity of data in its use in its lung disease outside of CF. Current availability of easy to use, repeatable and reliable devices allows LCI to be measured in the clinic setting (Downing et al. 2016).
Understanding the relationship between CT changes and LCI in younger children with lung disease, would allow a non-invasive investigation (LCI) to be used to guide care and monitor treatment.
In order to understand how LCI changes, we also intend to determine how LCI varies in children with Non-CF, Non-PCD Bronchiectasis over a prolonged period of time.
The investigators hypothesize that in younger children with Non-CF, Non-PCD Bronchiectasis and evidence of milder disease on CT, LCI is a more sensitive disease marker than FEV1, and varies over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | Experimental | Diagnostic Test: Lung Clearance Index |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children
Key exclusion criteria (1 listed)
- Those with underlying respiratory/systemic disease/ prematurity
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 |
|---|---|---|
| Lung Clearance IndexNormative values in healthy children from ethnic backgrounds | Diagnostic test | observational |
Primary outcome
Normative values in healthy children
Time frame: 24 months
The normative range of measurements of lung clearance index will be determined
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 14 Aug 2023.
- 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.
Prasad Nagakumar, MD principal investigator
Birmingham Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Clearance Index in people with Healthy Children and Bronchiectasis Adult, run by Birmingham Women's and Children's 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 1 inclusion and 1 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 14 Aug 2023. 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?
Normative values in healthy children (time frame: 24 months). 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 14 Aug 2023.