Cystic FibrosisOCSI-CFNCT06909903
Cell Content of Sputum Induced by Hypertonic Saline in Adolescents With Cystic Fibrosis
A study testing Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis. in people with Cystic Fibrosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Cystic fibrosis requires regular monitoring of bacterial colonization of sputum. The collection is done during scheduled consultations or urgently during exacerbations during the respiratory physiotherapy session, which is increasingly often associated with nebulization of Hypertonic Salt Serum (SSH). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2021to 10 Oct 2021
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent between 12 and 17 years old with definite cystic fibrosis (two CFTR gene mutations identified and positive sweat test)
- Patient followed at the pediatric CRCM of Marseille
- Patient able to expectorate spontaneously and master autogenous drainage
- Patient in stable clinical condition for 1 month
Who cannot join
- Patient refusing the study
- Patient under systemic antibiotic therapy
- Patient with respiratory decompensation or upper airway infection
- Patient with oxygen saturation < 92% before nebulization
- Patient with hemoptysis in the last 3 months
- Patients with decompensated heart failure
Trial locations and contacts
1 site in 1 country.
France1 site
Médecine Physique et réadaptation - CHU Timone Enfants
Marseille, France, 13385
About this study
Cystic fibrosis requires regular monitoring of bacterial colonization of sputum. The collection is done during scheduled consultations or urgently during exacerbations during the respiratory physiotherapy session, which is increasingly often associated with nebulization of Hypertonic Salt Serum (SSH). This allows, compared to simple expectoration, to obtain a greater density and diversity of germs. However, no study has focused on researching the precise place of origin of the collected secretions. Our aim is therefore to compare, in this pilot study in 20 adolescents suffering from cystic fibrosis and regularly followed at the pediatric CRCM, the ratio between squamous cells (CM, ENT origin) and broncho-alveolar cells in sputum obtained spontaneously and induced with of the SSH (collaboration with Professor Roll). The secondary criteria are the CM/bronchial cell ratio, the CM/alveolar macrophage ratio, cell viability and microbiological diversity. The hypothesis of this research is as follows: the nebulization of SSH before expectoration makes it possible to obtain a greater quantity of secretions from the broncho-alveolar sphere than during simple expectoration. In the cohort of 165 patients followed at the pediatric CRCM of Marseille, only 25 patients correspond to the inclusion criteria: they are between 12 and 17 years old, master autogenous drainage as well as spontaneous expectoration in sufficient quantity to carry out the research. They must also have been in stable clinical condition for at least one month. Taking into account the non-inclusion criteria (refusal to participate, systemic antibiotic therapy, respiratory decompensation or upper airway infection, SpO2 less than 92% before nebulization, appearance of hemoptysis in the last three months), the number of subjects is fixed. To 20. Each patient participates in a single day of hospitalization scheduled at the pediatric CRCM: at 9 a.m. simple expectoration and at 1 p.m., expectoration caused by SSH. The subject is therefore his own witness. The study inclusion period is one year.
- Conditions
- Cystic Fibrosis
- Being tested
- Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis.
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis.Procedure or surgery
The procedure will be performed at the same session as follows :
- 30 minutes of autogenous drainage, followed by collection of secretions.
- 10 minutes of HSS followed by 30 minutes of autogenous drainage before secretions are collected.
The intervention first step involves verifying patient tolerance to Hypertonic saline solution nebulization (Auscultation, peak flow, saturtion levels), followed by the inhalation of 2 puffs of Ventolin® to prevent bronchospasm. Ten minutes later, the patient undergoes a 10-minute nebulization of 4 mL SSH 6% carried out according to the HAS recommendations.
The patient tolerance to SSH is reassessed. If there are no adverse reactions, the patient continues the protocol. If issues like wheezing, a ≥5% drop in SpO2, or a ≥20% drop in Peak Flow occur, 4 more puffs of Ventolin® are given, and the patient is reassessed.If still intolerant, the patient exits the study.
The session ends with physiotherapy (autogenous drainage) to aid mucus clearance.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous sputum followed by sputum induced by Hypertonic Saline | Other | Part 1: At 9:00 a.m., we begin the physiotherapy session in the form of autogenic drainage for 30 minutes, then collection of secretions (ECBC No. 1 in two 40 mL CBC pots). The order of the physiotherapy sessions, with and without SSH, was decided based on the possible interactions between the two proposed treatments. SSH nebulization has a prolonged fluidifying effect over several hours and could influence the collection of secretions. Autogenic drainage would have the same effect, but for a maximum duration of 2 to 3 hours. The patient continues the usual course of visits to the CRCM.
Part 2: At 2:00 p.m., we set up the protocol for expectoration induced by SSH nebulization, then we perform autogenous drainage for 30 minutes and collect the secretions (ECBC No. 2 in two 40 mL CBC pots). One of the pots is sent to Pr Roll's cytology laboratory and the other to Pr Drancourt's bacteriology laboratory within 30 minutes. Receives: Procedure: Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of 2 methods of secretion collection by assessing the percentage of squamous cells compared to the percentage of bronchoalveolar cells
Compare, in adolescents with cystic fibrosis, the efficiency of 2 methods of secretion collection (during spontaneous sputum or during sputum induced by HSS) concerning the origin of the collected secretions judged by the study of the distribution of cells of the ENT sphere (squamous cells - SC) and of bronchoalveolar cells.
Measured: Visit 0 at Month 0
Secondary outcomes (4)
Ratio of squamous cells to bronchial cells by cytological analysis of sputum samples
Measured: Visit 0 at Month 0
Ratio of squamous cells to alveolar macrophages by cytological analysis of sputum samples
Measured: Visit 0 at Month 0
Observe cell viability by assessing the percentage of dead cells
Measured: Visit 0 at Month 0
Assess the density and microbiological diversity of sputum
Measured: Visit 0 at Month 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start20 Jul 2021
- Primary completion10 Oct 2021
- Study completion10 Oct 2021
Why it stopped: difficulty including the last participants
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 Hopitaux De MarseilleThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject crossover study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hôpitaux de MarseilleJean-Christophe DUBUS, Principal investigator, CHU Timone Enfants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909903
- Sponsor's protocol ID
- 2020-60
- Acronym
- OCSI-CF
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 4 Apr 2025
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Content of Sputum Induced by Hypertonic Saline in Adolescents With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06909903
- Acronym / sponsor ID
- OCSI-CF / 2020-60
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty including the last participants
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 4 Apr 2025 (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.
Cystic fibrosis requires regular monitoring of bacterial colonization of sputum. The collection is done during scheduled consultations or urgently during exacerbations during the respiratory physiotherapy session, which is increasingly often associated with nebulization of Hypertonic Salt Serum (SSH). This allows, compared to simple expectoration, to obtain a greater density and diversity of germs. However, no study has focused on researching the precise place of origin of the collected secretions. Our aim is therefore to compare, in this pilot study in 20 adolescents suffering from cystic fibrosis and regularly followed at the pediatric CRCM, the ratio between squamous cells (CM, ENT origin) and broncho-alveolar cells in sputum obtained spontaneously and induced with of the SSH (collaboration with Professor Roll). The secondary criteria are the CM/bronchial cell ratio, the CM/alveolar macrophage ratio, cell viability and microbiological diversity. The hypothesis of this research is as follows: the nebulization of SSH before expectoration makes it possible to obtain a greater quantity of secretions from the broncho-alveolar sphere than during simple expectoration. In the cohort of 165 patients followed at the pediatric CRCM of Marseille, only 25 patients correspond to the inclusion criteria: they are between 12 and 17 years old, master autogenous drainage as well as spontaneous expectoration in sufficient quantity to carry out the research. They must also have been in stable clinical condition for at least one month. Taking into account the non-inclusion criteria (refusal to participate, systemic antibiotic therapy, respiratory decompensation or upper airway infection, SpO2 less than 92% before nebulization, appearance of hemoptysis in the last three months), the number of subjects is fixed. To 20. Each patient participates in a single day of hospitalization scheduled at the pediatric CRCM: at 9 a.m. simple expectoration and at 1 p.m., expectoration caused by SSH. The subject is therefore his own witness. The study inclusion period is one year.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject crossover study
| Arm | Type | Receives |
|---|---|---|
| Spontaneous sputum followed by sputum induced by Hypertonic Saline | Other | Procedure: Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis.Part 1: At 9:00 a.m., we begin the physiotherapy session in the form of autogenic drainage for 30 minutes, then collection of secretions (ECBC No. 1 in two 40 mL CBC pots). The order of the physiotherapy sessions, with and without SSH, was decided based on the possible interactions between the two proposed treatments. SSH nebulization has a prolonged fluidifying effect over several hours and could influence the collection of secretions. Autogenic drainage would have the same effect, but for a maximum duration of 2 to 3 hours. The patient continues the usual course of visits to the CRCM. Part 2: At 2:00 p.m., we set up the protocol for expectoration induced by SSH nebulization, then we perform autogenous drainage for 30 minutes and collect the secretions (ECBC No. 2 in two 40 mL CBC pots). One of the pots is sent to Pr Roll's cytology laboratory and the other to Pr Drancourt's bacteriology laboratory within 30 minutes. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescent between 12 and 17 years old with definite cystic fibrosis (two CFTR gene mutations identified and positive sweat test)
- Patient followed at the pediatric CRCM of Marseille
- Patient able to expectorate spontaneously and master autogenous drainage
- Patient in stable clinical condition for 1 month
Key exclusion criteria (6 listed)
- Patient refusing the study
- Patient under systemic antibiotic therapy
- Patient with respiratory decompensation or upper airway infection
- Patient with oxygen saturation < 92% before nebulization
- Patient with hemoptysis in the last 3 months
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 |
|---|---|---|
| Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis.The procedure will be performed at the same session as follows : * 30 minutes of autogenous drainage, followed by collection of secretions. * 10 minutes of HSS followed by 30 minutes of autogenous drainage before secretions are collected. The intervention first step involves verifying patient tolerance to Hypertonic saline solution nebulization (Auscultation, peak flow, saturtion levels), followed by the inhalation of 2 puffs of Ventolin® to prevent bronchospasm. Ten minutes later, the patient undergoes a 10-minute nebulization of 4 mL SSH 6% carried out according to the HAS recommendations. The patient tolerance to SSH is reassessed. If there are no adverse reactions, the patient continues the protocol. If issues like wheezing, a ≥5% drop in SpO2, or a ≥20% drop in Peak Flow occur, 4 more puffs of Ventolin® are given, and the patient is reassessed.If still intolerant, the patient exits the study. The session ends with physiotherapy (autogenous drainage) to aid mucus clearance. | Procedure or surgery | Spontaneous sputum followed by sputum induced by Hypertonic Saline |
Primary outcome
Efficiency of 2 methods of secretion collection by assessing the percentage of squamous cells compared to the percentage of bronchoalveolar cells
Time frame: Visit 0 at Month 0
Compare, in adolescents with cystic fibrosis, the efficiency of 2 methods of secretion collection (during spontaneous sputum or during sputum induced by HSS) concerning the origin of the collected secretions judged by the study of the distribution of cells of the ENT sphere (squamous cells - SC) and of bronchoalveolar cells.
4 secondary outcomes
Ratio of squamous cells to bronchial cells by cytological analysis of sputum samples
Time frame: Visit 0 at Month 0
Ratio of squamous cells to alveolar macrophages by cytological analysis of sputum samples
Time frame: Visit 0 at Month 0
Observe cell viability by assessing the percentage of dead cells
Time frame: Visit 0 at Month 0
Assess the density and microbiological diversity of sputum
Time frame: Visit 0 at Month 0
Results and safety
The study was stopped early (reason given: difficulty including the last participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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.
François CREMIEUX study director
Assistance Publique Hôpitaux de Marseille
Jean-Christophe DUBUS principal investigator
CHU Timone Enfants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis. in people with Cystic Fibrosis, run by Assistance Publique Hopitaux De Marseille 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 6 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: stopped early, as of the sponsor's last update on 4 Apr 2025. 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 was stopped early (reason given: difficulty including the last participants). Results are not available in the source record.
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?
Efficiency of 2 methods of secretion collection by assessing the percentage of squamous cells compared to the percentage of bronchoalveolar cells (time frame: Visit 0 at 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 4 Apr 2025.