Cystic FibrosisMUCOCAPNCT04814797
Use of Capnography for the Follow-up of Cystic Fibrosis Children
An observational study of Cystic Fibrosis, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
The respiratory system involvement in cystic fibrosis(CF) influences the prognosis and course of disease. Respiratory assessment is based on spirometry, but its main parameter, the maximal expiratory volume in the first second (FEV1), does not reflect the initial peripheral impairment of airways. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Capnography data included in Lung Clearance Index measurement
- How many people
- 76 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2021to 31 Dec 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children are recruited from subjects diagnosed with cystic fibrosis followed-up at the pediatric reference center of University Children's Hospital of Nancy and Trousseau of Paris (46 children from Nancy and 30 children from Paris). These children are referred by the pneumopediatricians to the Pediatric Pulmonary Function Testing Lab for a complete, annually, routinely follow-up assessment of respiratory function. An analysis of the capnography data included in the Lung Clearance Index measurement, which is part of the routine assessment of the CF child, will be performed. The complete routine yearly PFT in order to ensure the follow-up in CF children is composed of 4 techniques: measurement of lung volumes by plethysmography (1), measurement of lung volumes by helium dilution technique (2); LCI measurement (3); spirometry (4). The outcomes needed for this research are obtained by these techniques.
Who may be able to join
None listed.
Who cannot join
- other chronic respiratory pathology (bronchopulmonary dysplasia, virosis sequelae, inhalation pathology, thoraco-pulmonary malformation, tracheomalacia);
- anatomical or functional abnormalities of the pharyngolaryngeal pathway (tonsils hypertrophy grade 3 or 4, laryngomalacia, subglottic stenosis, vocal cord paralysis, any other laryngeal obstacle);
- congenital or acquired heart disease.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
CHRU de NANCY
Nancy, 54035
Iulia-Cristina IOAN
Iulia-Cristina IOAN
- Recruiting
Hôpital ARMAND TROUSSEAU
Paris, 75571
Nicole BEYDON
Nicole BEYDON
About this study
Official title: The Study of Capnography for the Follow-up of Cystic Fibrosis Children With or Without Gas Trapping
The respiratory system involvement in cystic fibrosis(CF) influences the prognosis and course of disease. Respiratory assessment is based on spirometry, but its main parameter, the maximal expiratory volume in the first second (FEV1), does not reflect the initial peripheral impairment of airways. Another pulmonary function test (PFT) validated for CF children follow-up is measurement of "gas trapping", reflecting ventilation inhomogeneity and incipient airways impairment. "Gas trapping" can be obtained by lung volume measurement (functional residual capacity, FRC) by plethysmography and helium dilution technique, but these tests are inconvenient for children due to their long length (~30min). A complete PFT is routinely performed once a year. It also includes a measurement of Lung Clearance Index (LCI) reflecting ventilation inhomogeneity. Capnography is a non-invasive PFT technique, does not require subject's active cooperation, is of short duration and could replace the traditional PFT for CF children follow-up. The capnograph is integrated into the device measuring LCI and data can be retrieved and analyzed afterwards. Capnographic indices reflect ventilation inhomogeneity.
The hypothesis is that capnographic indices change in the presence/absence of "gas trapping" in CF children.
Read more
The main objective is to show that the capnographic index of efficacy (EFFi) is significantly different between CF children "with gas trapping" and CF children "without gas trapping". The secondary objectives are:
- to compare the other capnographic indices between CF children "with gas trapping" and CF children "without gas trapping": the slope of the ascending phase, α; the slope of the alveolar plateau, β; the angle Q between α and β; the positive peak of the first-order derivative, F'CO2, which reflects the ascending phase; the first negative peak of the 2nd order derivative, F "CO2, which reflects the curvature between the ascending phase and the alveolar plateau.
- to compare the results of the capnographic indices with the results of the FEV1 in identifying the presence / absence of "gas trapping";
- to compare the results of the capnographic indices with the results of the LCI in identifying the presence / absence of "gas trapping"
Read the detailed description
Cystic fibrosis (CF) is the most common inherited genetic disorder in Caucasian children. It affects several organs, the most important being the involvement of the respiratory system. The respiratory condition influences the prognosis and the course of the disease, the respiratory complications being the main cause of mortality and morbidity. The respiratory assessment is based on spirometry, but the maximal expiratory volume in the first second (FEV1) does not reflect the initial peripheral impairment of airways and can remain within normal limits for a long time. Another pulmonary function test (PFT) validated for the follow-up of CF children is the measurement of "gas trapping", very frequent in these children, reflecting the ventilation inhomogeneity and incipient airways impairment. "Gas trapping" can be obtained by the measurement of lung volume (functional residual capacity, FRC) by plethysmography and helium dilution technique, but these tests are very inconvenient for children due to their long length (~ 30 minutes). This complete PFT is routinely performed every year. It also includes a measurement of Lung Clearance Index (LCI) which reflects the presence of ventilation inhomogeneity. Capnography is a non-invasive PFT technique that does not require subject's active cooperation, is of short duration and could replace the traditional PFT techniques for the follow-up of CF children. Capnographic indices also reflect the presence of ventilation inhomogeneity. The capnograph is integrated into the device that measures the LCI and data can be retrieved and analyzed following the LCI measurement.
In this study, 2 groups of children will be identified by the gold-standard: 1 / children with "gas trapping" (defined by the ratio between the difference in the plethysmographic FRC (FRCpleth) and FRC obtained by the helium dilution technique (FRCHe) divided by FRCpleth of >10%) and 2 / children without "gas trapping" (defined by (FRCpleth-FRCHe) / FRCpleth of ≤ <10%). Capnography data (included in LCI measurement) will be collected in these children and capnographic indices will be compared between these two groups.
The study hypothesis is that capnographic indices change in the presence or absence of "gas trapping" in CF children.
The importance of capnography is that is a test less inconvenient for follow-up and better accepted by children because of its short length, easy-to-use tool for monitoring disease progression and monitoring the effectiveness of treatments.
The main objective is to show that the capnographic index of efficacy (EFFi), in CF children is significantly different between subjects "with gas trapping" (defined by the gold standard ((FRCpleth - FRCHe) / FRCpleth) > 10%) and subjects "without gas trapping" (defined by the gold standard ((FRCpleth-FRCHe) / FRCpleth) ≤10%).
The secondary objectives are:
- to compare the other capnographic indices between CF children "with gas trapping" and CF children "without gas trapping": the slope of the ascending phase, α; the slope of the alveolar plateau, β; the angle Q between α and β; the positive peak of the first-order derivative, F'CO2, which reflects the ascending phase; the first negative peak of the 2nd order derivative, F"CO2, which reflects the curvature between the ascending phase and the alveolar plateau.
- to compare the results of the capnographic indices with the results of the FEV1 in identifying the presence / absence of "gas trapping";
- to compare the results of the capnographic indices with the results of the LCI in identifying the presence / absence of "gas trapping",
- Conditions
- Cystic Fibrosis
- Being tested
- Capnography data included in Lung Clearance Index measurement
- Keywords
- Pulmonary function testing
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnography data included in Lung Clearance Index measurementOther
Capnography data included in Lung Clearance Index measurement (a pulmonary function test included in routinely yearly follow-up of cystic fibrosis children) will be collected and analyzed
| Study group | Role | What they receive |
|---|---|---|
| CF children "with gas trapping" | CF children "with gas trapping" will be defined by a ratio between the difference of functional residual capacity (FRC) obtained by plethysmography (FRCpleth) and FRC obtained by helium dilution method (FRCHe) divided by the FRCpleth of >10% Receives: Other: Capnography data included in Lung Clearance Index measurement | |
| CF children "without gas trapping" | CF children "without gas trapping" will be defined by a ratio between the difference of the functional residual capacity (FRC) obtained by plethysmography (FRCpleth) and FRC obtained by helium dilution method (FRCHe) divided by the FRCpleth of ≤10% Receives: Other: Capnography data included in Lung Clearance Index measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency index (EFFi) Gold standard (CRFpleth - CRFHe) / CRFpleth to differentiate between subjects "with" gas trapping (defined by> 10%) and subjects "without" gas trapping (defined by ≤10%).
Value of the capnographic efficiency index (EFFi), for each of the children of the two groups studied . easurement included in the device that measures LCI, collected after LCI measurement
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Other capnographic indices
Value of capnographic indices for each of the children of the two groups studied ; Data collected after PFT
Measured: through study completion, an average of 6 months
Forced expiratory volume in the first second (FEV1)
The value of FEV1 obtained by spirometry for each of the children of the two groups studied
Measured: through study completion, an average of 6 months
Lung Clearance Index (LCI)
Value of Lung Clearance Index for each of the children of the two groups studied
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start5 May 2021
- Primary completion30 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Iulia IOAN, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814797
- Sponsor's protocol ID
- 2020PI150
- Acronym
- MUCOCAP
- Status last verified
- Jul 2021
- First submitted
- 18 Mar 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robinson PD, Latzin P, Ramsey KA, Stanojevic S, Aurora P, Davis SD, Gappa M, Hall GL, Horsley A, Jensen R, Lum S, Milla C, Nielsen KG, Pittman JE, Rosenfeld M, Singer F, Subbarao P, Gustafsson PM, Ratjen F; ATS Assembly on Pediatrics. Preschool Multiple-Breath Washout Testing. An Official American Thoracic Society Technical Statement. Am J Respir Crit Care Med. 2018 Mar 1;197(5):e1-e19. doi: 10.1164/rccm.201801-0074ST.
PubMed 29493315BEDELL GN, MARSHALL R, DUBOIS AB, COMROE JH. Plethysmographic determination of the volume of gas trapped in the lungs. J Clin Invest. 1956 Jun;35(6):664-70. doi: 10.1172/JCI103323. No abstract available.
PubMed 13319505Kraemer R, Schoni MH. Ventilatory inequalities, pulmonary function and blood oxygenation in advanced states of cystic fibrosis. Respiration. 1990;57(5):318-24. doi: 10.1159/000195864.
PubMed 2284509O'Donnell CR, Bankier AA, Stiebellehner L, Reilly JJ, Brown R, Loring SH. Comparison of plethysmographic and helium dilution lung volumes: which is best for COPD? Chest. 2010 May;137(5):1108-15. doi: 10.1378/chest.09-1504. Epub 2009 Dec 18.
PubMed 20022972Jarenback L, Tufvesson E, Ankerst J, Bjermer L, Jonson B. The Efficiency Index (EFFi), based on volumetric capnography, may allow for simple diagnosis and grading of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 27;13:2033-2039. doi: 10.2147/COPD.S161345. eCollection 2018.
PubMed 29988757Ioan I, Demoulin B, Duvivier C, Leblanc AL, Bonabel C, Marchal F, Schweitzer C, Varechova S. Frequency dependence of capnography in anesthetized rabbits. Respir Physiol Neurobiol. 2014 Jan 1;190:14-9. doi: 10.1016/j.resp.2013.09.002. Epub 2013 Sep 12.
PubMed 24035836Gustafsson PM, Aurora P, Lindblad A. Evaluation of ventilation maldistribution as an early indicator of lung disease in children with cystic fibrosis. Eur Respir J. 2003 Dec;22(6):972-9. doi: 10.1183/09031936.03.00049502.
PubMed 14680088You B, Peslin R, Duvivier C, Vu VD, Grilliat JP. Expiratory capnography in asthma: evaluation of various shape indices. Eur Respir J. 1994 Feb;7(2):318-23. doi: 10.1183/09031936.94.07020318.
PubMed 8162985
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Capnography for the Follow-up of Cystic Fibrosis Children With or Without Gas Trapping
- ClinicalTrials.gov ID
- NCT04814797
- Acronym / sponsor ID
- MUCOCAP / 2020PI150
- Conditions
- Cystic Fibrosis
- Keywords
- Pulmonary function testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Mar 2021 (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.
The respiratory system involvement in cystic fibrosis(CF) influences the prognosis and course of disease. Respiratory assessment is based on spirometry, but its main parameter, the maximal expiratory volume in the first second (FEV1), does not reflect the initial peripheral impairment of airways. Another pulmonary function test (PFT) validated for CF children follow-up is measurement of "gas trapping", reflecting ventilation inhomogeneity and incipient airways impairment. "Gas trapping" can be obtained by lung volume measurement (functional residual capacity, FRC) by plethysmography and helium dilution technique, but these tests are inconvenient for children due to their long length (~30min). A complete PFT is routinely performed once a year. It also includes a measurement of Lung Clearance Index (LCI) reflecting ventilation inhomogeneity. Capnography is a non-invasive PFT technique, does not require subject's active cooperation, is of short duration and could replace the traditional PFT for CF children follow-up. The capnograph is integrated into the device measuring LCI and data can be retrieved and analyzed afterwards. Capnographic indices reflect ventilation inhomogeneity.
The hypothesis is that capnographic indices change in the presence/absence of "gas trapping" in CF children.
The main objective is to show that the capnographic index of efficacy (EFFi) is significantly different between CF children "with gas trapping" and CF children "without gas trapping". The secondary objectives are:
- to compare the other capnographic indices between CF children "with gas trapping" and CF children "without gas trapping": the slope of the ascending phase, α; the slope of the alveolar plateau, β; the angle Q between α and β; the positive peak of the first-order derivative, F'CO2, which reflects the ascending phase; the first negative peak of the 2nd order derivative, F "CO2, which reflects the curvature between the ascending phase and the alveolar plateau.
- to compare the results of the capnographic indices with the results of the FEV1 in identifying the presence / absence of "gas trapping";
- to compare the results of the capnographic indices with the results of the LCI in identifying the presence / absence of "gas trapping"
Detailed description
Cystic fibrosis (CF) is the most common inherited genetic disorder in Caucasian children. It affects several organs, the most important being the involvement of the respiratory system. The respiratory condition influences the prognosis and the course of the disease, the respiratory complications being the main cause of mortality and morbidity. The respiratory assessment is based on spirometry, but the maximal expiratory volume in the first second (FEV1) does not reflect the initial peripheral impairment of airways and can remain within normal limits for a long time. Another pulmonary function test (PFT) validated for the follow-up of CF children is the measurement of "gas trapping", very frequent in these children, reflecting the ventilation inhomogeneity and incipient airways impairment. "Gas trapping" can be obtained by the measurement of lung volume (functional residual capacity, FRC) by plethysmography and helium dilution technique, but these tests are very inconvenient for children due to their long length (~ 30 minutes). This complete PFT is routinely performed every year. It also includes a measurement of Lung Clearance Index (LCI) which reflects the presence of ventilation inhomogeneity. Capnography is a non-invasive PFT technique that does not require subject's active cooperation, is of short duration and could replace the traditional PFT techniques for the follow-up of CF children. Capnographic indices also reflect the presence of ventilation inhomogeneity. The capnograph is integrated into the device that measures the LCI and data can be retrieved and analyzed following the LCI measurement.
In this study, 2 groups of children will be identified by the gold-standard: 1 / children with "gas trapping" (defined by the ratio between the difference in the plethysmographic FRC (FRCpleth) and FRC obtained by the helium dilution technique (FRCHe) divided by FRCpleth of >10%) and 2 / children without "gas trapping" (defined by (FRCpleth-FRCHe) / FRCpleth of ≤ <10%). Capnography data (included in LCI measurement) will be collected in these children and capnographic indices will be compared between these two groups.
The study hypothesis is that capnographic indices change in the presence or absence of "gas trapping" in CF children.
The importance of capnography is that is a test less inconvenient for follow-up and better accepted by children because of its short length, easy-to-use tool for monitoring disease progression and monitoring the effectiveness of treatments.
The main objective is to show that the capnographic index of efficacy (EFFi), in CF children is significantly different between subjects "with gas trapping" (defined by the gold standard ((FRCpleth - FRCHe) / FRCpleth) > 10%) and subjects "without gas trapping" (defined by the gold standard ((FRCpleth-FRCHe) / FRCpleth) ≤10%).
The secondary objectives are:
- to compare the other capnographic indices between CF children "with gas trapping" and CF children "without gas trapping": the slope of the ascending phase, α; the slope of the alveolar plateau, β; the angle Q between α and β; the positive peak of the first-order derivative, F'CO2, which reflects the ascending phase; the first negative peak of the 2nd order derivative, F"CO2, which reflects the curvature between the ascending phase and the alveolar plateau.
- to compare the results of the capnographic indices with the results of the FEV1 in identifying the presence / absence of "gas trapping";
- to compare the results of the capnographic indices with the results of the LCI in identifying the presence / absence of "gas trapping",
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF children "with gas trapping" | – | Other: Capnography data included in Lung Clearance Index measurementCF children "with gas trapping" will be defined by a ratio between the difference of functional residual capacity (FRC) obtained by plethysmography (FRCpleth) and FRC obtained by helium dilution method (FRCHe) divided by the FRCpleth of >10% |
| CF children "without gas trapping" | – | Other: Capnography data included in Lung Clearance Index measurementCF children "without gas trapping" will be defined by a ratio between the difference of the functional residual capacity (FRC) obtained by plethysmography (FRCpleth) and FRC obtained by helium dilution method (FRCHe) divided by the FRCpleth of ≤10% |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children are recruited from subjects diagnosed with cystic fibrosis followed-up at the pediatric reference center of University Children's Hospital of Nancy and Trousseau of Paris (46 children from Nancy and 30 children from Paris). These children are referred by the pneumopediatricians to the Pediatric Pulmonary Function Testing Lab for a complete, annually, routinely follow-up assessment of respiratory function. An analysis of the capnography data included in the Lung Clearance Index measurement, which is part of the routine assessment of the CF child, will be performed. The complete routine yearly PFT in order to ensure the follow-up in CF children is composed of 4 techniques: measurement of lung volumes by plethysmography (1), measurement of lung volumes by helium dilution technique (2); LCI measurement (3); spirometry (4). The outcomes needed for this research are obtained by these techniques.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- other chronic respiratory pathology (bronchopulmonary dysplasia, virosis sequelae, inhalation pathology, thoraco-pulmonary malformation, tracheomalacia);
- anatomical or functional abnormalities of the pharyngolaryngeal pathway (tonsils hypertrophy grade 3 or 4, laryngomalacia, subglottic stenosis, vocal cord paralysis, any other laryngeal obstacle);
- congenital or acquired heart 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 |
|---|---|---|
| Capnography data included in Lung Clearance Index measurementCapnography data included in Lung Clearance Index measurement (a pulmonary function test included in routinely yearly follow-up of cystic fibrosis children) will be collected and analyzed | Other | CF children "with gas trapping", CF children "without gas trapping" |
Primary outcome
Efficiency index (EFFi) Gold standard (CRFpleth - CRFHe) / CRFpleth to differentiate between subjects "with" gas trapping (defined by> 10%) and subjects "without" gas trapping (defined by ≤10%).
Time frame: through study completion, an average of 6 months
Value of the capnographic efficiency index (EFFi), for each of the children of the two groups studied . easurement included in the device that measures LCI, collected after LCI measurement
3 secondary outcomes
Other capnographic indices
Time frame: through study completion, an average of 6 months
Forced expiratory volume in the first second (FEV1)
Time frame: through study completion, an average of 6 months
Lung Clearance Index (LCI)
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Background: PubMed 29493315Robinson PD, Latzin P, Ramsey KA, Stanojevic S, Aurora P, Davis SD, Gappa M, Hall GL, Horsley A, Jensen R, Lum S, Milla C, Nielsen KG, Pittman JE, Rosenfeld M, Singer F, Subbarao P, Gustafsson PM, Ratjen F; ATS Assembly on Pediatrics. Preschool Multiple-Breath Washout Testing. An Official American Thoracic Society Technical Statement. Am J Respir Crit Care Med. 2018 Mar 1;197(5):e1-e19. doi: 10.1164/rccm.201801-0074ST.
- Background: PubMed 13319505BEDELL GN, MARSHALL R, DUBOIS AB, COMROE JH. Plethysmographic determination of the volume of gas trapped in the lungs. J Clin Invest. 1956 Jun;35(6):664-70. doi: 10.1172/JCI103323. No abstract available.
- Background: PubMed 2284509Kraemer R, Schoni MH. Ventilatory inequalities, pulmonary function and blood oxygenation in advanced states of cystic fibrosis. Respiration. 1990;57(5):318-24. doi: 10.1159/000195864.
- Background: PubMed 20022972O'Donnell CR, Bankier AA, Stiebellehner L, Reilly JJ, Brown R, Loring SH. Comparison of plethysmographic and helium dilution lung volumes: which is best for COPD? Chest. 2010 May;137(5):1108-15. doi: 10.1378/chest.09-1504. Epub 2009 Dec 18.
- Background: PubMed 29988757Jarenback L, Tufvesson E, Ankerst J, Bjermer L, Jonson B. The Efficiency Index (EFFi), based on volumetric capnography, may allow for simple diagnosis and grading of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 27;13:2033-2039. doi: 10.2147/COPD.S161345. eCollection 2018.
- Background: PubMed 24035836Ioan I, Demoulin B, Duvivier C, Leblanc AL, Bonabel C, Marchal F, Schweitzer C, Varechova S. Frequency dependence of capnography in anesthetized rabbits. Respir Physiol Neurobiol. 2014 Jan 1;190:14-9. doi: 10.1016/j.resp.2013.09.002. Epub 2013 Sep 12.
- Background: PubMed 14680088Gustafsson PM, Aurora P, Lindblad A. Evaluation of ventilation maldistribution as an early indicator of lung disease in children with cystic fibrosis. Eur Respir J. 2003 Dec;22(6):972-9. doi: 10.1183/09031936.03.00049502.
- Background: PubMed 8162985You B, Peslin R, Duvivier C, Vu VD, Grilliat JP. Expiratory capnography in asthma: evaluation of various shape indices. Eur Respir J. 1994 Feb;7(2):318-23. doi: 10.1183/09031936.94.07020318.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
2 sites 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, run by Central Hospital, Nancy, France at 2 sites 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 0 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Iulia Ioan, MD PhD (+33 3 83 15 47 94, ic.ioan@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency index (EFFi) Gold standard (CRFpleth - CRFHe) / CRFpleth to differentiate between subjects "with" gas trapping (defined by> 10%) and subjects "without" gas trapping (defined by ≤10%). (time frame: through study completion, an average of 6 months). 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 NCT04814797, which also lists 8 linked publications.
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 30 Jul 2021.