Nasal DiseaseBIONOSENCT06407102
Collection of Primary Human
A study testing Collection of nasal cells during programme surgery in people with Nasal Disease, run by University Hospital, Tours at 1 site in France.
Trial summary
Treatment and prevention of respiratory infections are of great interest in many medical areas. Create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Disease
- What is being tested?
- Collection of nasal cells during programme surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2024to 2 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (age > 18 years) whose native language is French, or who understands French.
- Affiliation with a French social security system (CMU accepted).
- Informed consent, written and signed by the participant.
- Planned rhinological surgery (meatotomy, septoplasty or turbinoplasty for example, but other surgeries as well)
Who cannot join
- Patients under court protection, guardianship or curatorship.
- Pregnant or breast-feeding women (positive pregnancy test for women of childbearing age).
- Patients presenting a major alteration of the mucosa or a malignant rhinosinus pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Collection of Primary Human Nasal Epithelial Cells
Treatment and prevention of respiratory infections are of great interest in many medical areas. Create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. In this context the aim of this project is to create a collection of primary cells from the human nasal epithelium.
This collection will be realised during programmed surgery, thanks to a specific device dedicated to collect nasal cells. Then the cells will be sent to the lab in order to grow at the air-liquid interface, which is an excellent 'ex vivo' model for their study.
Read the detailed description
The treatment and prevention of respiratory infections caused by emerging viruses or antibiotic-resistant bacteria are major societal and medical challenges. Inhalation allows drugs to be administered in the form of a spray or aerosol, directly into the respiratory tract (nose or lung). This is a validated approach for the non-invasive delivery of drugs to prevent and treat respiratory diseases, particularly infectious ones. Primary human nasal cell cultures grown at the air-liquid interface are an excellent 'ex vivo' model for their study in a physiological and pathophysiological context, and for testing new therapies, including aerosols. In addition, this culture model also offers an alternative to animal experimentation.
The aim of this project is therefore to create a collection of primary cells from the human nasal epithelium.
The main objective is to obtain a minimum of 60 samples of nasal epithelial cells from patients that can be cultured in air-liquid interface. The secondary objectives are to be able to study these nasal cells under physiological and pathophysiological conditions. The cells will first be amplified to constitute a cell biobank. They will then be studied under physiological conditions (anatomical and functional characterisation). Finally, they can be used to establish different models of infection or inflammation, in order to test future aerosol drugs.
- Conditions
- Nasal Disease
- Being tested
- Collection of nasal cells during programme surgery
- Keywords
- nasal cells, Respiratory epithelium
- Medical subject headings
- Nose Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of nasal cells during programme surgeryOther
During programmed surgery (meatotomy, septoplasty or turbinoplasty for example, or other programmed surgeries), the surgeon will take an atraumatic sample from the nasal cavity using a dedicated device (brush) from the healthy nasal mucosa.
| Study group | Role | What they receive |
|---|---|---|
| Patient with programmed surgery | Other | Patient programmed with surgery of meatotomy, septoplasty or turbinoplasty, or other programmed surgeries Receives: Other: Collection of nasal cells during programme surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of viability of nasal epithelial cells from the operating room to laboratory
Collect nasal epithelial cells that can be grown in vitro in an air-liquid interface
Measured: 6 hours
Secondary outcomes (1)
Percentage of efficacy of the procedure
Percentage of samples that can actually be cultivated following transfer to the laboratory.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start6 Dec 2024
- Primary completion2 May 2027 (estimated)
- Study completion2 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407102
- Sponsor's protocol ID
- DR230317
- Acronym
- BIONOSE
- Status last verified
- Jun 2026
- First submitted
- 6 May 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Primary Human Nasal Epithelial Cells
- ClinicalTrials.gov ID
- NCT06407102
- Acronym / sponsor ID
- BIONOSE / DR230317
- Conditions
- Nasal Disease
- Keywords
- nasal cells, Respiratory epithelium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 May 2028 (estimated)
- First posted
- 9 May 2024 (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.
Treatment and prevention of respiratory infections are of great interest in many medical areas. Create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. In this context the aim of this project is to create a collection of primary cells from the human nasal epithelium.
This collection will be realised during programmed surgery, thanks to a specific device dedicated to collect nasal cells. Then the cells will be sent to the lab in order to grow at the air-liquid interface, which is an excellent 'ex vivo' model for their study.
Detailed description
The treatment and prevention of respiratory infections caused by emerging viruses or antibiotic-resistant bacteria are major societal and medical challenges. Inhalation allows drugs to be administered in the form of a spray or aerosol, directly into the respiratory tract (nose or lung). This is a validated approach for the non-invasive delivery of drugs to prevent and treat respiratory diseases, particularly infectious ones. Primary human nasal cell cultures grown at the air-liquid interface are an excellent 'ex vivo' model for their study in a physiological and pathophysiological context, and for testing new therapies, including aerosols. In addition, this culture model also offers an alternative to animal experimentation.
The aim of this project is therefore to create a collection of primary cells from the human nasal epithelium.
The main objective is to obtain a minimum of 60 samples of nasal epithelial cells from patients that can be cultured in air-liquid interface. The secondary objectives are to be able to study these nasal cells under physiological and pathophysiological conditions. The cells will first be amplified to constitute a cell biobank. They will then be studied under physiological conditions (anatomical and functional characterisation). Finally, they can be used to establish different models of infection or inflammation, in order to test future aerosol drugs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with programmed surgery | Other | Other: Collection of nasal cells during programme surgeryPatient programmed with surgery of meatotomy, septoplasty or turbinoplasty, or other programmed surgeries |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age > 18 years) whose native language is French, or who understands French.
- Affiliation with a French social security system (CMU accepted).
- Informed consent, written and signed by the participant.
- Planned rhinological surgery (meatotomy, septoplasty or turbinoplasty for example, but other surgeries as well)
Key exclusion criteria (3 listed)
- Patients under court protection, guardianship or curatorship.
- Pregnant or breast-feeding women (positive pregnancy test for women of childbearing age).
- Patients presenting a major alteration of the mucosa or a malignant rhinosinus pathology.
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 |
|---|---|---|
| Collection of nasal cells during programme surgeryDuring programmed surgery (meatotomy, septoplasty or turbinoplasty for example, or other programmed surgeries), the surgeon will take an atraumatic sample from the nasal cavity using a dedicated device (brush) from the healthy nasal mucosa. | Other | Patient with programmed surgery |
Primary outcome
Percentage of viability of nasal epithelial cells from the operating room to laboratory
Time frame: 6 hours
Collect nasal epithelial cells that can be grown in vitro in an air-liquid interface
1 secondary outcome
Percentage of efficacy of the procedure
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of nasal cells during programme surgery in people with Nasal Disease, run by University Hospital, Tours 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: looking for participants now, as of the sponsor's last update on 16 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Aussedat, MD (0247474747, c.aussedat@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of viability of nasal epithelial cells from the operating room to laboratory (time frame: 6 hours). 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 16 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.