Cystic FibrosisICP2DMNCT03323983
Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis
An observational study of Cystic Fibrosis and Lung Clearance Index, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Recent improvements in cystic fibrosis management have enabled an important subset of patients to maintain normal spirometry. Nevertheless, even in these patients with normal spirometry, chest computed tomography (CT) might identify structural lung abnormalities such as bronchiectasis, mucus plugging, bronchiolitis… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Cystic Fibrosis, Lung Clearance Index
- What is being tested?
- data collection
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 Nov 2016
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between 10 to 17 years old with a diagnosis of cystic fibrosis
Who may be able to join
- children between 10 to 17 years old with a diagnosis of cystic fibrosis confirmed by sweat test and genetic test
- pulmonary function test and incremental cardiopulmonary exercise test included in their follow-up
- lung function preserved (FEV1 greater than the lower limit of normal)
- affiliation to the French social security
- children and their legal guardians informed of the use of anonymised data
Who cannot join
- recent respiratory infection
- association with another obstructive respiratory disease, especially with asthma
About this study
Official title: Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis (Étude du Lien Entre la Distension Dynamique et l'Indice de Clairance Pulmonaire Dans la Mucoviscidose)
Recent improvements in cystic fibrosis management have enabled an important subset of patients to maintain normal spirometry. Nevertheless, even in these patients with normal spirometry, chest computed tomography (CT) might identify structural lung abnormalities such as bronchiectasis, mucus plugging, bronchiolitis and air trapping.
Lung clearance index (LCI) has been shown to correlate well with structural pulmonary alterations seen on CT even in CF patients with well-preserved spirometry. In cystic fibrosis, a high LCI is associated with a worse feeling of illness assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R). School-aged CF patients with normal spirometry also have normal aerobic function as assessed by peak oxygen uptake (V̇O2) measured during symptom-limited incremental cardiopulmonary exercise test. However, the ability of LCI to predict ventilatory abnormalities appearing at exercise in CF patients has not been investigated. The investigators therefore aimed to compare physiological parameters at exercise between CF patients with elevated LCI (i.e., LCI above the upper limit of normal [ULN]) and patients with normal LCI, all with preserved spirometry.
- Conditions
- Cystic Fibrosis, Lung Clearance Index
- Being tested
- data collection
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection
| Study group | Role | What they receive |
|---|---|---|
| Normal lung clearance index | Not described Receives: Other: data collection | |
| Elevated lung clearance index | Not described Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to explore the relationship between elevated lung clearance index and dynamic hyperinflation in cystic fibrosis patients with preserved pulmonary function.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 May 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
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.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323983
- Sponsor's protocol ID
- P/2016/293
- Acronym
- ICP2DM
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 27 Oct 2017
- 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 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Link Between Dynamic Hyperinflation and Lung Clearance Index in Cystic Fibrosis (Étude du Lien Entre la Distension Dynamique et l'Indice de Clairance Pulmonaire Dans la Mucoviscidose)
- ClinicalTrials.gov ID
- NCT03323983
- Acronym / sponsor ID
- ICP2DM / P/2016/293
- Conditions
- Cystic Fibrosis, Lung Clearance Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 27 Oct 2017 (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.
Recent improvements in cystic fibrosis management have enabled an important subset of patients to maintain normal spirometry. Nevertheless, even in these patients with normal spirometry, chest computed tomography (CT) might identify structural lung abnormalities such as bronchiectasis, mucus plugging, bronchiolitis and air trapping.
Lung clearance index (LCI) has been shown to correlate well with structural pulmonary alterations seen on CT even in CF patients with well-preserved spirometry. In cystic fibrosis, a high LCI is associated with a worse feeling of illness assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R). School-aged CF patients with normal spirometry also have normal aerobic function as assessed by peak oxygen uptake (V̇O2) measured during symptom-limited incremental cardiopulmonary exercise test. However, the ability of LCI to predict ventilatory abnormalities appearing at exercise in CF patients has not been investigated. The investigators therefore aimed to compare physiological parameters at exercise between CF patients with elevated LCI (i.e., LCI above the upper limit of normal [ULN]) and patients with normal LCI, all with preserved spirometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal lung clearance index | – | Other: data collection |
| Elevated lung clearance index | – | Other: data collection |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 10 to 17 years old with a diagnosis of cystic fibrosis
Key inclusion criteria (5 listed)
- children between 10 to 17 years old with a diagnosis of cystic fibrosis confirmed by sweat test and genetic test
- pulmonary function test and incremental cardiopulmonary exercise test included in their follow-up
- lung function preserved (FEV1 greater than the lower limit of normal)
- affiliation to the French social security
- children and their legal guardians informed of the use of anonymised data
Key exclusion criteria (2 listed)
- recent respiratory infection
- association with another obstructive respiratory disease, especially with asthma
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 |
|---|---|---|
| data collectiondata collection | Other | Elevated lung clearance index, Normal lung clearance index |
Primary outcome
The main objective is to explore the relationship between elevated lung clearance index and dynamic hyperinflation in cystic fibrosis patients with preserved pulmonary function.
Time frame: day 1
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 27 Oct 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Lung Clearance Index, run by Centre Hospitalier Universitaire de Besancon.
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 5 inclusion and 2 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The main objective is to explore the relationship between elevated lung clearance index and dynamic hyperinflation in cystic fibrosis patients with preserved pulmonary function. (time frame: day 1). 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 27 Oct 2017.