Cystic FibrosisLCINCT02342951
Evaluation of the Lung Clearance Index
A study testing Lung clearance index determination in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine the efficacy of a non invasive method of detecting the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as possible. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Lung clearance index determination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jul 2019
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with typical cystic fibrosis (sweat chloride level >60 mEq/l) followed in reference centre participating to the study
- From 3 to 6 years old
- Children with a planned annual assessment that required thoracic computed tomography and lung function test
- Children with informed and non opposed parents
Who cannot join
- Children with atypical cystic fibrosis
- Children with bronchial exacerbation dating less than 2 weeks
- Children with severe associated disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lung Clearance Index for Early Detection of Lung Disease in Young Children With Cystic Fibrosis
The purpose of this study is to determine the efficacy of a non invasive method of detecting the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as possible.
Moreover this screening procedure permits to note the improvement following the treatment and to choose the optimal treatment in term of efficacy.
Read the detailed description
It is mandatory to detect as early as possible lung CF disease in the young child with CF to initiate active therapies limiting irreversible lesions. Lung Clearance Index (LCI) which evaluates gas clearance from the alveolar volume is an easy to-do technique in pre-school children.
Main objective To evaluate correlation between LCI and thoracic low dose computed tomodensitometry (CT) endpoints at initial visit Secondary objectives
- To evaluate correlation between LCI and respiratory function measurements at each visit
- To evaluate correlation between the evolution of LCI and respiratory function endpoints and the evolution of CT only for the children for whom a thoracic low dose CT is requested by their referent doctor after two years.
- To evaluate LCI predictive value for respiratory function 2 years later in preschool children.
This is a prospective multicenter cohort study. Study visits will be performed each year during the annual check up for normal follow up of the child.
Initial visit (Visit 1) takes place during an annual check-up during which a low dose CT was prescribed. It will include following tests: LCI, Lung function tests (LFTs) performed according to age (forced volumes and flows, plethysmographic specific airway resistances and interrupter resistances), and a low dose CT scan performed according a standardized protocol.
Visit 2 will be performed 12 ± 3 months later and will include following tests: LCI , LFTs.
Visit 3 will be performed 24 ± 3 months later and will include following tests: LCI , LFTs and, if judged necessary by the child's referent doctor, a low dose CT scan performed according to a standardized protocol.
Anthropometric data, infection history, treatment will be collected at each visit.
Recruiting period: 1 year Study period: 2 years per patient, 3 years as a whole LCI will help to evaluate early ventilation inhomogeneity due to small bronchi abnormalities in young children with CF. Concordance between LCI and CT endpoints evaluation will help to define the frequency of lung CT administration in young CF children. Predictive value for later abnormal lung function development will be evaluated. This will help to detect the children at risk to develop abnormal lung function and to target those requiring active treatment. Finally this endpoint will be very valuable in the future therapeutic trials for CFTR correctors or potentiators.
- Conditions
- Cystic Fibrosis
- Being tested
- Lung clearance index determination
- Keywords
- Cystic fibrosis,, lung clearance index,, pulmonary function
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung clearance index determinationOther
Lung clearance index determination
| Study group | Role | What they receive |
|---|---|---|
| LCI | Other | Measure of lung clearance index Receives: Other: Lung clearance index determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of nitrogen washout and Brody 2 score
Measured: Month 0
Secondary outcomes (2)
measure of FEV (Correlation between the evolution of LCI and respiratory function endpoints and CT)
Correlation between the evolution of LCI and respiratory function endpoints and CT
Measured: 2 years
measure of FEV (Evaluation of LCI predictive value for respiratory function in preschool children)
Evaluation of LCI predictive value for respiratory function in preschool children.
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 posted21 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Muriel Le Bourgeois, MD, Principal investigator, Service de pneumologie pédiatrique, Hôpital Necker-Enfants Malades Assistance Publique Hôpitaux de Paris 75015 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342951
- Sponsor's protocol ID
- K151013
- Other IDs
- IDRCB-2013-A01175-40
- Acronym
- LCI
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2014
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Clearance Index for Early Detection of Lung Disease in Young Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02342951
- Acronym / sponsor ID
- LCI / K151013
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis,, lung clearance index,, pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Jan 2015 (estimated)
- 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.
The purpose of this study is to determine the efficacy of a non invasive method of detecting the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as possible.
Moreover this screening procedure permits to note the improvement following the treatment and to choose the optimal treatment in term of efficacy.
Detailed description
It is mandatory to detect as early as possible lung CF disease in the young child with CF to initiate active therapies limiting irreversible lesions. Lung Clearance Index (LCI) which evaluates gas clearance from the alveolar volume is an easy to-do technique in pre-school children.
Main objective To evaluate correlation between LCI and thoracic low dose computed tomodensitometry (CT) endpoints at initial visit Secondary objectives
- To evaluate correlation between LCI and respiratory function measurements at each visit
- To evaluate correlation between the evolution of LCI and respiratory function endpoints and the evolution of CT only for the children for whom a thoracic low dose CT is requested by their referent doctor after two years.
- To evaluate LCI predictive value for respiratory function 2 years later in preschool children.
This is a prospective multicenter cohort study. Study visits will be performed each year during the annual check up for normal follow up of the child.
Initial visit (Visit 1) takes place during an annual check-up during which a low dose CT was prescribed. It will include following tests: LCI, Lung function tests (LFTs) performed according to age (forced volumes and flows, plethysmographic specific airway resistances and interrupter resistances), and a low dose CT scan performed according a standardized protocol.
Visit 2 will be performed 12 ± 3 months later and will include following tests: LCI , LFTs.
Visit 3 will be performed 24 ± 3 months later and will include following tests: LCI , LFTs and, if judged necessary by the child's referent doctor, a low dose CT scan performed according to a standardized protocol.
Anthropometric data, infection history, treatment will be collected at each visit.
Recruiting period: 1 year Study period: 2 years per patient, 3 years as a whole LCI will help to evaluate early ventilation inhomogeneity due to small bronchi abnormalities in young children with CF. Concordance between LCI and CT endpoints evaluation will help to define the frequency of lung CT administration in young CF children. Predictive value for later abnormal lung function development will be evaluated. This will help to detect the children at risk to develop abnormal lung function and to target those requiring active treatment. Finally this endpoint will be very valuable in the future therapeutic trials for CFTR correctors or potentiators.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCI | Other | Other: Lung clearance index determinationMeasure of lung clearance index |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with typical cystic fibrosis (sweat chloride level >60 mEq/l) followed in reference centre participating to the study
- From 3 to 6 years old
- Children with a planned annual assessment that required thoracic computed tomography and lung function test
- Children with informed and non opposed parents
Key exclusion criteria (3 listed)
- Children with atypical cystic fibrosis
- Children with bronchial exacerbation dating less than 2 weeks
- Children with severe associated disease
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 index determinationLung clearance index determination | Other | LCI |
Primary outcome
measure of nitrogen washout and Brody 2 score
Time frame: Month 0
2 secondary outcomes
measure of FEV (Correlation between the evolution of LCI and respiratory function endpoints and CT)
Time frame: 2 years
measure of FEV (Evaluation of LCI predictive value for respiratory function in preschool children)
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 3 Apr 2026.
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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.
Muriel Le Bourgeois, MD principal investigator
Service de pneumologie pédiatrique, Hôpital Necker-Enfants Malades Assistance Publique Hôpitaux de Paris 75015 Paris, France
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 determination in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 3 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 3 Apr 2026. 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 France. 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?
measure of nitrogen washout and Brody 2 score (time frame: Month 0). 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 3 Apr 2026.