Cystic Fibrosis in ChildrenMODUL-CFNCT04301856
Response to CFTR Modulators in CF Patients Under 18 Years
An observational study of Cystic Fibrosis in Children, run by Societe Francaise de la Mucoviscidose at 1 site in France.
Trial summary
CFTR modulators should improve the prognosis of Cystic Fibrosis. Identifying patients under the age of 18 responding to CFTR modulators as well as detecting possible toxicity is an important medical objective given the potential side effects and the high cost of these molecules. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- CFTR Modulators
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jan 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cystic fibrosis under the age of 18 eligible for CFTR modulator thérapies according to french national recommandations
Who may be able to join
- Children with cystic fibrosis under the age of 18 under CFTR modulator therapy
Who cannot join
- Patients with cystic fibrosis without indication for CFTR modulator therapy
- Patients over the age of 18
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Sermet-Gaudelus Isabelle
Paris, 75015
Isabelle Sermet-Gaudelus, MD PhD, 0033687078403, isabelle.sermet@aphp.fr
About this study
Official title: Evaluation of the Response to CFTR Modulators in Patients With Cystic Fibrosis Less Than 18 Years of Age
CFTR modulators should improve the prognosis of Cystic Fibrosis. Identifying patients under the age of 18 responding to CFTR modulators as well as detecting possible toxicity is an important medical objective given the potential side effects and the high cost of these molecules.
This observational follow-up cohort study is carried out as part of routine care.
Read more
The main objective is to assess the evolution of pulmonary structural impairment by low-dose CF scan at the end of the first year of CFTR modulator therapy.
The secondary objectives are to evaluate structural impairment at low dose scan at 3 years and 5 years of CFTR modulator treatment, the evolution of respiratory functional parameters, growth, puberty, lung infection, sweat test, quality of life and pancreatic function, as well as tolerance of modulators including liver toxicity.
Read the detailed description
Cystic fibrosis (CF) is a deadly disease. This is due to overinfected chronic obstructive pulmonary disease that progresses to end-stage respiratory failure. CFTR modulators should improve the prognosis of CF, as they may slow the progression of patients' lung disease. Assessing their impact in the paediatric population is becoming a major issue. Children and adolescents under the age of 18 are a target cohort because they have a lung disease that is still poorly developed. Early prescription of CFTR modulators is therefore a priority but requires evidence of absence of toxicity. Identifying patients under the age of 18 responding to CFTR modulators as well as detecting possible toxicity, is an important medical objective given the potential side effects and the high cost of these molecules.
The outcomes previously used in Phase III studies (FEV1, frequency of exacerbations, nutritional status) are insufficiently sensitive in this population.
Other criteria need to be analyzed to identify the response to CFTR modulators in the short and medium term. The investigators hypothesize that the assessment of pulmonary structural impairment by low-dose lung CT-scan as part of routine care could be a much more sensitive criterion for the development of lung disease under CFTR modulators.
This observational follow-up cohort study is carried out as part of routine care. It does not involve a specific collection for research. Excess bronchial secretions and blood will be kept instead of being discarded in the event of a possible requalification for research.
The main objective is to assess the evolution of pulmonary structural impairment by low-dose CF scan at the end of the first year of CFTR modulator therapy The secondary objectives are to assess following criteria
- Tolerance of modulators in this age group, including screening for bronchial reactivity at treatment, early liver toxicity
- Longitudinal evolution of pulmonary structural impairment by low dose scan at 3 years and 5 years of CFTR modulator treatment
- Evolution of respiratory functional parameters
- Measurement by spirometry and plethysmography
- Lung clearance index (if possible)
- Longitudinal evolution of bacterial colonization, compared to the year prior to modulating treatment
- Exacerbations: number, duration, days of antibiotics, hospitalizations, return to stable condition
- Colonization of bronchial secretions
- Changes in quality of life
- Evolution of the sweat test
- Longitudinal evaluation of pancreatic function
- Longitudinal evaluation of growth and puberty compared to the year prior to CFTR modulator
- Growth speed, and bone age
- Bone mineralization, body composition (if possible)
- Pubertal markers from 9 years in girls and 10 years in boys
- Evaluation of glycemic dysregulation if present
- Preservation of samples taken as part of routine care (serum, bronchial secretions) for possible research use
- Conditions
- Cystic Fibrosis in Children
- Being tested
- CFTR Modulators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFTR ModulatorsDrug
Also called Orkambi, Kalydeko...
CFTR modulators as recommended in routine care by the french health authorities
| Study group | Role | What they receive |
|---|---|---|
| CF children treated with CFTR modul | Cystic fibrosis patients under 18 years treated with CFTR modulators according to french health recommendations observational cohort study Receives: Drug: CFTR Modulators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Imaging
Lung structural injury assessed by Low Dose CT, as part of routine care
Measured: at initiation, as part of national guidelines
Lung Imaging
Lung structural injury assessed by Low Dose CT, as part of routine care
Measured: at 1 year, as part of national guidelines
Lung Imaging
Lung structural injury assessed by Low Dose CT, as part of routine care
Measured: at 3 years, as part of national guidelines
Lung Imaging
Lung structural injury assessed by Low Dose CT, as part of routine care
Measured: at 5 years, as part of national guidelines
Secondary outcomes (25)
weight in kilogrammes
weight in kilogrammes (associated with a retrospective collection in the year prior to treatment)
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
height in meters
height in meters (associated with a retrospective collection in the year prior to treatment)
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
pubertal evolution
pubertal evolution (associated with a retrospective collection in the year prior to treatment)
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
bronchial infectious exacerbations
bronchial infectious exacerbations (associated with a retrospective collection in the year prior to treatment)
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Forced Expiratory Volume in 1 second(FEV1)
Forced Expiratory Volume in 1 second(FEV1) in liter
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) in liter
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Force Expiratory Flow 50 (FEV50)
Force Expiratory Flow 50 (FEV50) in liter
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Forced Expiratory Flow 25-75 (FEV25-75)
Forced Expiratory Flow 25-75 (FEV25-75) in liter
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Residual Volume (RV)
Residual Volume (RV) in liter
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Total Pulmonary Capacity
Total Pulmonary Capacity in liter
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Lung Clearance Index - Lung Clearance Index
Lung clearance of nitrogen
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
colonization of bronchial secretions
bacteria, fungi, mycobacteria
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
quality of life questionnaire
CFQ questionnaire for children above 8 years: worse 0, better 100
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
ENT quality of life questionnaire
SN-score: better score 1, worse 7
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Abdominal quality of life questionnaire
better score: 0, worse: 25
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
liver ultrasound
liver ultrasound
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
elastometry (data available in centers with the necessary equipment)
elastometry (data available in centers with the necessary equipment)
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
sweat test
sweat collection
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
serum and fecal pancreatic biological markers
immunoreactive trypsin, lipase, amylase, vitamin A and E, Prothrombin time, and fecal (fecal elastase
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
bone biological markers
25OHvitD, Ca, P, PTH, Osteocalcin, IgF1, IgF1BP3, CTX
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
bone maturation
Zscore (in relation to height and sex and weight) (data available in centers with the necessary equipment)
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
puberty
serum dosage of FSH, LH, Estradiol, testosterone Pelvic ultrasound if puberty initiated in girls
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
intestine inflammation
fecal Calprotectine
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
glycemic regulation
monitoring of glycemic dysregulation ( as routinely done in the centers)
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
side effects: declarative collection and monitoring
declarative collection and monitoring
Measured: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis in 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societe Francaise de la Mucoviscidose
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle SERMET-GAUDELUS, Societe Francaise de la Mucoviscidose
- Investigators
- Isabelle Sermet-Gaudelus, MD PhD, Principal investigator, Société Francaise de la Mucoviscidose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301856
- Sponsor's protocol ID
- 0011928
- Acronym
- MODUL-CF
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sermet-Gaudelus I, Letierce A, Berteloot L, Bonnel AS, Chen Y, Makani P, Kelly-Aubert M, Kanoun F, Penalva L, Bouleghem N, Bihouee T, Bui S, Corvol H, Houdouin V, Mittaine M, Tatopoulos A, Weiss L, Wizla N, Kapel N, Bessou A, Tiddens HAWM, Caudri D, Reix P, Marguet C; MODUL-CF study group. Effect of elexacaftor-tezacaftor-ivacaftor on bronchial dilatations in adolescents with cystic fibrosis: a multicentre prospective observational study. Lancet Respir Med. 2026 Jan;14(1):38-48. doi: 10.1016/S2213-2600(25)00248-6. Epub 2025 Oct 22.
PubMed 41138737
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Response to CFTR Modulators in Patients With Cystic Fibrosis Less Than 18 Years of Age
- ClinicalTrials.gov ID
- NCT04301856
- Acronym / sponsor ID
- MODUL-CF / 0011928
- Conditions
- Cystic Fibrosis in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Societe Francaise de la MucoviscidoseUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Mar 2020 (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.
CFTR modulators should improve the prognosis of Cystic Fibrosis. Identifying patients under the age of 18 responding to CFTR modulators as well as detecting possible toxicity is an important medical objective given the potential side effects and the high cost of these molecules.
This observational follow-up cohort study is carried out as part of routine care.
The main objective is to assess the evolution of pulmonary structural impairment by low-dose CF scan at the end of the first year of CFTR modulator therapy.
The secondary objectives are to evaluate structural impairment at low dose scan at 3 years and 5 years of CFTR modulator treatment, the evolution of respiratory functional parameters, growth, puberty, lung infection, sweat test, quality of life and pancreatic function, as well as tolerance of modulators including liver toxicity.
Detailed description
Cystic fibrosis (CF) is a deadly disease. This is due to overinfected chronic obstructive pulmonary disease that progresses to end-stage respiratory failure. CFTR modulators should improve the prognosis of CF, as they may slow the progression of patients' lung disease. Assessing their impact in the paediatric population is becoming a major issue. Children and adolescents under the age of 18 are a target cohort because they have a lung disease that is still poorly developed. Early prescription of CFTR modulators is therefore a priority but requires evidence of absence of toxicity. Identifying patients under the age of 18 responding to CFTR modulators as well as detecting possible toxicity, is an important medical objective given the potential side effects and the high cost of these molecules.
The outcomes previously used in Phase III studies (FEV1, frequency of exacerbations, nutritional status) are insufficiently sensitive in this population.
Other criteria need to be analyzed to identify the response to CFTR modulators in the short and medium term. The investigators hypothesize that the assessment of pulmonary structural impairment by low-dose lung CT-scan as part of routine care could be a much more sensitive criterion for the development of lung disease under CFTR modulators.
This observational follow-up cohort study is carried out as part of routine care. It does not involve a specific collection for research. Excess bronchial secretions and blood will be kept instead of being discarded in the event of a possible requalification for research.
The main objective is to assess the evolution of pulmonary structural impairment by low-dose CF scan at the end of the first year of CFTR modulator therapy The secondary objectives are to assess following criteria
- Tolerance of modulators in this age group, including screening for bronchial reactivity at treatment, early liver toxicity
- Longitudinal evolution of pulmonary structural impairment by low dose scan at 3 years and 5 years of CFTR modulator treatment
- Evolution of respiratory functional parameters
- Measurement by spirometry and plethysmography
- Lung clearance index (if possible)
- Longitudinal evolution of bacterial colonization, compared to the year prior to modulating treatment
- Exacerbations: number, duration, days of antibiotics, hospitalizations, return to stable condition
- Colonization of bronchial secretions
- Changes in quality of life
- Evolution of the sweat test
- Longitudinal evaluation of pancreatic function
- Longitudinal evaluation of growth and puberty compared to the year prior to CFTR modulator
- Growth speed, and bone age
- Bone mineralization, body composition (if possible)
- Pubertal markers from 9 years in girls and 10 years in boys
- Evaluation of glycemic dysregulation if present
- Preservation of samples taken as part of routine care (serum, bronchial secretions) for possible research use
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF children treated with CFTR modul | – | Drug: CFTR ModulatorsCystic fibrosis patients under 18 years treated with CFTR modulators according to french health recommendations observational cohort study |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cystic fibrosis under the age of 18 eligible for CFTR modulator thérapies according to french national recommandations
Key inclusion criteria (1 listed)
- Children with cystic fibrosis under the age of 18 under CFTR modulator therapy
Key exclusion criteria (3 listed)
- Patients with cystic fibrosis without indication for CFTR modulator therapy
- Patients over the age of 18
- Pregnant or lactating women
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 |
|---|---|---|
| CFTR ModulatorsAlso: Orkambi, Kalydeko...CFTR modulators as recommended in routine care by the french health authorities | Drug | CF children treated with CFTR modul |
Primary outcome
Lung Imaging
Time frame: at initiation, as part of national guidelines
Lung structural injury assessed by Low Dose CT, as part of routine care
Lung Imaging
Time frame: at 1 year, as part of national guidelines
Lung structural injury assessed by Low Dose CT, as part of routine care
Lung Imaging
Time frame: at 3 years, as part of national guidelines
Lung structural injury assessed by Low Dose CT, as part of routine care
Lung Imaging
Time frame: at 5 years, as part of national guidelines
Lung structural injury assessed by Low Dose CT, as part of routine care
25 secondary outcomes
weight in kilogrammes
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
height in meters
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
pubertal evolution
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
bronchial infectious exacerbations
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Forced Expiratory Volume in 1 second(FEV1)
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Forced Vital Capacity (FVC)
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Force Expiratory Flow 50 (FEV50)
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Forced Expiratory Flow 25-75 (FEV25-75)
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Residual Volume (RV)
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Total Pulmonary Capacity
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Lung Clearance Index - Lung Clearance Index
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
colonization of bronchial secretions
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
quality of life questionnaire
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
ENT quality of life questionnaire
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Abdominal quality of life questionnaire
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
liver ultrasound
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
elastometry (data available in centers with the necessary equipment)
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
sweat test
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
serum and fecal pancreatic biological markers
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
bone biological markers
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
bone maturation
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
puberty
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
intestine inflammation
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
glycemic regulation
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
side effects: declarative collection and monitoring
Time frame: longitudinal monitoring of assessments carried out as part of routine care during 5 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Derived from this study: PubMed 41138737Sermet-Gaudelus I, Letierce A, Berteloot L, Bonnel AS, Chen Y, Makani P, Kelly-Aubert M, Kanoun F, Penalva L, Bouleghem N, Bihouee T, Bui S, Corvol H, Houdouin V, Mittaine M, Tatopoulos A, Weiss L, Wizla N, Kapel N, Bessou A, Tiddens HAWM, Caudri D, Reix P, Marguet C; MODUL-CF study group. Effect of elexacaftor-tezacaftor-ivacaftor on bronchial dilatations in adolescents with cystic fibrosis: a multicentre prospective observational study. Lancet Respir Med. 2026 Jan;14(1):38-48. doi: 10.1016/S2213-2600(25)00248-6. Epub 2025 Oct 22.
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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.
Isabelle Sermet-Gaudelus, MD PhD principal investigator
Société Francaise de la Mucoviscidose
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 Cystic Fibrosis in Children, run by Societe Francaise de la Mucoviscidose 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 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Mazur, PhD (0033427855043, stephane.mazur@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Imaging (time frame: at initiation, as part of national guidelines). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301856, which also lists 1 linked publication.
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 22 Mar 2021.