Pulmonary Disease, Chronic ObstructiveDISCOVAIRNCT04529993
An Atlas of Airways at a Single Cell Level in Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Controls
A study testing Bronchoscopy in people with Pulmonary Disease, Chronic Obstructive and Interstitial Pulmonary Fibrosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The increasing incidence of chronic respiratory disease is a public health problem that affects hundreds of thousands of people worldwide at all ages. Directly exposed to atmospheric airborne contaminants (pollution, allergens), the respiratory tract represents a complex ecosystem involving different cells… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Interstitial Pulmonary Fibrosis
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2020to 18 Nov 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of acute pathology
- Absence of symptom evoking an evolutionary pathology
- For healthy volunteers :
- Non-smoker (active or passive) or ex-smoker of less than 5 packet-years and quit for more than 10 years.
- Absence of known significant chronic pathology
- Normal Respiratory Function Test (RFT)
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- Woman of childbearing age using an effective method of contraception
- For COPD patients :
- Diagnosis of COPD based on dyspnea, chronic cough or sputum production, a history of recurrent lower respiratory tract infections and/or a history of exposure to risk factors for the disease associated with spirometry that demonstrates a post-bronchodilator FEV1/FVC ratio < 0.70 and lack of reversibility.
- Stage GOLD 1 (post-bronchodilator FEV1 ≥ 80% theoretical) or 2 (post-bronchodilator FEV1 between 50 and less than 80% theoretical) or 3 (post-bronchodilator FEV1 between 30 and less than 50% theoretical) For IPF patients
- Diagnosis of idiopathic pulmonary fibrosis made less than 5 years ago on the basis of scannographic and/or histological criteria and validated at a consultation meeting on interstitial pathology according to the ATS/ERS/JRS/ALAT 2018 recommendations.
Who cannot join
- Recent rhino-bronchial infection (< 6 weeks)
- Subjects on antiplatelet or other anticoagulant medication at risk of bleeding during sampling.
- Subjects with a history of clinically significant vaginal discomfort (i.e., recurrent or unconsciousness, etc.)
- History of allergy or intolerance to xylocaine and/or propofol
- History of significant epistaxis (i.e. recurrent epistaxis of any quantity or at least one severe epistaxis)
- Subject at risk of difficult intubation according to the criteria of the 2006 FSSR expert conference*.
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- Pregnant (a urine test will be performed for all women of childbearing age) or breastfeeding woman
- For patients :
- Long-term systemic corticosteroid therapy regardless of the reason for the prescription.
- Systemic corticosteroid therapy within the previous 3 months
- Patient on long-term oxygen therapy
- Chronic cardiovascular, neuro-psychic, metabolic pathology in progress, clinically significant or uncontrolled in the last 6 months
- Other associated chronic respiratory pathology (COPD, asbestosis, bronchiectasis ...)
Trial locations and contacts
1 site in 1 country.
About this study
The increasing incidence of chronic respiratory disease is a public health problem that affects hundreds of thousands of people worldwide at all ages. Directly exposed to atmospheric airborne contaminants (pollution, allergens), the respiratory tract represents a complex ecosystem involving different cells (multiciliated, basal, mucosecretory, neuroendocrine, etc.) that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and the local microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, investigators have demonstrated large gene expression gradients between samples taken from the nasal and bronchial airways in different studies. Specifying the cellular variability throughout the respiratory tree in a normal physiological situation is one of the major objectives defined in the establishment of an atlas of all airway cells, as defined in the objectives of the international consortium Human Cell Atlas.
The sequencing of the RNAs present specifically in each individual cell ("single-cell RNAseq"), and its comparison with neighbouring cells allows to document the precise cellular contributions, as well as the signalling pathways involved. The development of tissue sampling, stabilization, transport and single cell analysis procedures can be performed on primary respiratory epithelium cultures and can also be extended to respiratory samples from healthy volunteers.
Read more
This project will analyze gene expression profiles at the single cell level (single cell RNAseq) in volunteers with chronic obstructive pulmonary disease, interstitial pulmonary fibrosis and compared to healthy subjects of the same age. The technical modalities of the samples will be brushing and staged airway biopsies for direct analysis of the samples. This approach will be complemented by an air-liquid interface culture to allow secondary analysis in single cell RNAseq and three-dimensional mapping of the distribution of these cells with single cell in situ analysis.
Thanks to sampling at several levels of the respiratory tree (nose, bronchioles, bronchioles), cellular and gene expression variations along the tracheobronchial axis will be exhaustively documented in subjects of different ages, healthy or suffering from pathologies such as chronic obstructive pulmonary disease and interstitial pulmonary fibrosis. These data will serve as worldwide references for comparisons in different physiological and pathological contexts.
- Being tested
- Bronchoscopy
- Keywords
- lung, nasal mucosa, respiratory mucosa
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Multiple level sampling of the respiratory mucosa (cytology brush and biopsies forceps)
| Study group | Role | What they receive |
|---|---|---|
| Interstitial pulmonary fibrosis | Experimental | Not described Receives: Procedure: Bronchoscopy |
| Chronic obstructive pulmonary disease | Experimental | Not described Receives: Procedure: Bronchoscopy |
| Healthy volunteers | Experimental | Not described Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of samples usable
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start18 Nov 2020
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie LEROY, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529993
- Sponsor's protocol ID
- 20-PP-06
- Acronym
- DISCOVAIR
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2020
- Last updated
- 24 Mar 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Atlas of Airways at a Single Cell Level in Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Controls
- ClinicalTrials.gov ID
- NCT04529993
- Acronym / sponsor ID
- DISCOVAIR / 20-PP-06
- Keywords
- lung, nasal mucosa, respiratory mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 28 Aug 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.
The increasing incidence of chronic respiratory disease is a public health problem that affects hundreds of thousands of people worldwide at all ages. Directly exposed to atmospheric airborne contaminants (pollution, allergens), the respiratory tract represents a complex ecosystem involving different cells (multiciliated, basal, mucosecretory, neuroendocrine, etc.) that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and the local microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, investigators have demonstrated large gene expression gradients between samples taken from the nasal and bronchial airways in different studies. Specifying the cellular variability throughout the respiratory tree in a normal physiological situation is one of the major objectives defined in the establishment of an atlas of all airway cells, as defined in the objectives of the international consortium Human Cell Atlas.
The sequencing of the RNAs present specifically in each individual cell ("single-cell RNAseq"), and its comparison with neighbouring cells allows to document the precise cellular contributions, as well as the signalling pathways involved. The development of tissue sampling, stabilization, transport and single cell analysis procedures can be performed on primary respiratory epithelium cultures and can also be extended to respiratory samples from healthy volunteers.
This project will analyze gene expression profiles at the single cell level (single cell RNAseq) in volunteers with chronic obstructive pulmonary disease, interstitial pulmonary fibrosis and compared to healthy subjects of the same age. The technical modalities of the samples will be brushing and staged airway biopsies for direct analysis of the samples. This approach will be complemented by an air-liquid interface culture to allow secondary analysis in single cell RNAseq and three-dimensional mapping of the distribution of these cells with single cell in situ analysis.
Thanks to sampling at several levels of the respiratory tree (nose, bronchioles, bronchioles), cellular and gene expression variations along the tracheobronchial axis will be exhaustively documented in subjects of different ages, healthy or suffering from pathologies such as chronic obstructive pulmonary disease and interstitial pulmonary fibrosis. These data will serve as worldwide references for comparisons in different physiological and pathological contexts.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interstitial pulmonary fibrosis | Experimental | Procedure: Bronchoscopy |
| Chronic obstructive pulmonary disease | Experimental | Procedure: Bronchoscopy |
| Healthy volunteers | Experimental | Procedure: Bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Absence of acute pathology
- Absence of symptom evoking an evolutionary pathology
- Non-smoker (active or passive) or ex-smoker of less than 5 packet-years and quit for more than 10 years.
- Absence of known significant chronic pathology
- Normal Respiratory Function Test (RFT)
Key exclusion criteria (13 listed)
- Recent rhino-bronchial infection (< 6 weeks)
- Subjects on antiplatelet or other anticoagulant medication at risk of bleeding during sampling.
- Subjects with a history of clinically significant vaginal discomfort (i.e., recurrent or unconsciousness, etc.)
- History of allergy or intolerance to xylocaine and/or propofol
- History of significant epistaxis (i.e. recurrent epistaxis of any quantity or at least one severe epistaxis)
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 |
|---|---|---|
| BronchoscopyMultiple level sampling of the respiratory mucosa (cytology brush and biopsies forceps) | Procedure or surgery | Chronic obstructive pulmonary disease, Healthy volunteers, Interstitial pulmonary fibrosis |
Primary outcome
Number of samples usable
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
Sylvie LEROY, Dr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Pulmonary Disease, Chronic Obstructive and Interstitial Pulmonary Fibrosis, run by Centre Hospitalier Universitaire de Nice 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 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of samples usable (time frame: 6 months). 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 24 Mar 2025.