Pulmonary Disease, Chronic ObstructiveRhéMucNCT03187860
Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients
A study testing Bronchial Biopsy and ALI culture in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma. Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface cell cultures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Asthma, Smoking
- What is being tested?
- Bronchial Biopsy and ALI culture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2019to 26 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- The subject has never smoked
- No obstructive breathing disorder (forced expiratory volume at one second (FEV1) >70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is > 0.7)
- No known respiratory disease
- The subject has given free and informed consent and signed the consent form
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- The subject is affiliated with or beneficiary of a medical insurance program
- Smoker or former smoker (>= 30 pack years)
- No obstructive breathing disorder (forced expiratory volume at one second (FEV1) >70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is > 0.7)
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- Smoker or former smoker (>= 30 pack years)
- Subject presenting with COPD: FEV1/FVC < 0.7 (based on spirometry values in the medical file and performed in the 3 months prior to inclusion)
- The subject requires bronchial fibroscopy (decision made by pneumologist)
- COPD of grade "2" or "3" according to GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- Non-smoker or former smoker (<10 pack years)
- Subject presenting with severe asthma: FEV1/FVC >= 0.7 and FEV1 < 80%
- The subjects requires bronchial fibroscopy (decision made by pneumologist)
Who cannot join
- The subject has an extensive neoplastic disease
- The subject has another active lung disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
- The subject has had a recent psychiatric disorder (within one year prior to inclusion and documented by a specialist consultation)
- Emergency situations (object extractions...)
- Subject consuming illicit drugs or alcohol
- The subject is in an exclusion period determined by a previous study
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- The subject is under judicial protection, or is an adult under any kind of guardianship
- It is impossible to correctly inform the patient
- The subject cannot fluently read French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demonstration of the Diagnostic Character of the Rheology of Mucus
This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.
Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface cell cultures. These will then be used to make observations concerning cilia and mucus rheology.
This is a first pilot study. The working hypothesis is that the largest group differences will be found for cilia densities; the latter metric was thus chosen as a primary criterion.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma, Smoking
- Being tested
- Bronchial Biopsy, ALI culture
- Keywords
- Bronchial epithelial cell, mucus, Air Liquid Interface
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial BiopsyProcedure or surgery
Bronchial biopsies will be performed on all subjects.
ALI cultureOther
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.
| Study group | Role | What they receive |
|---|---|---|
| Non-smoking controls | Experimental | Subjects in this group have never smoked and have no known lung disorders.
Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface) Receives: Procedure: Bronchial Biopsy; Other: ALI culture |
| Smokers without COPD | Experimental | Subjects in this group are smokers or former smokers who do not have signs of obstructive disease (no chronic obstructive pulmonary disease (COPD))
Intervention: Bronchial Biopsy + ALI culture Receives: Procedure: Bronchial Biopsy; Other: ALI culture |
| Smokers with COPD | Experimental | Subjects in this group are smokers or former smokers who have COPD
Intervention: Bronchial Biopsy + ALI culture Receives: Procedure: Bronchial Biopsy; Other: ALI culture |
| Severe asthma | Experimental | Subjects in this group are non-smokers or former (light) smokers who have severe asthma.
Intervention: Bronchial Biopsy + ALI culture Receives: Procedure: Bronchial Biopsy; Other: ALI culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface density of active cilia
Surface density of active cilia
Measured: Day 0 + approximately 2 months of cell culture time
Secondary outcomes (4)
Cilia beating frequency
The frequency at which cilia beat.
Measured: Day 0 + approximately 2 months of cell culture time
Mucus viscosity
The viscosity of mucus produced by cell cultures.
Measured: Day 0 + approximately 2 months of cell culture time
Mucus elasticity
The elasticity of mucus produced by cell cultures.
Measured: Day 0 + approximately 2 months of cell culture time
Cilia beat orientation
The direction in which cilia beat
Measured: Day 0 + approximately 2 months of cell culture time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start19 Jun 2019
- Primary completion26 Apr 2022
- Study completion26 Dec 2022
Why it stopped: Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.
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.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Sophie Gamez, MD, Study director, Montpellier University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187860
- Sponsor's protocol ID
- RECHMPL18_0222
- Acronym
- RhéMuc
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2017
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Diagnostic Character of the Rheology of Mucus
- ClinicalTrials.gov ID
- NCT03187860
- Acronym / sponsor ID
- RhéMuc / RECHMPL18_0222
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma, Smoking
- Keywords
- Bronchial epithelial cell, mucus, Air Liquid Interface
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 15 Jun 2017 (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.
This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.
Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface cell cultures. These will then be used to make observations concerning cilia and mucus rheology.
This is a first pilot study. The working hypothesis is that the largest group differences will be found for cilia densities; the latter metric was thus chosen as a primary criterion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-smoking controls | Experimental | Procedure: Bronchial Biopsy, Other: ALI cultureSubjects in this group have never smoked and have no known lung disorders. Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface) |
| Smokers without COPD | Experimental | Procedure: Bronchial Biopsy, Other: ALI cultureSubjects in this group are smokers or former smokers who do not have signs of obstructive disease (no chronic obstructive pulmonary disease (COPD)) Intervention: Bronchial Biopsy + ALI culture |
| Smokers with COPD | Experimental | Procedure: Bronchial Biopsy, Other: ALI cultureSubjects in this group are smokers or former smokers who have COPD Intervention: Bronchial Biopsy + ALI culture |
| Severe asthma | Experimental | Procedure: Bronchial Biopsy, Other: ALI cultureSubjects in this group are non-smokers or former (light) smokers who have severe asthma. Intervention: Bronchial Biopsy + ALI culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- The subject has never smoked
- No obstructive breathing disorder (forced expiratory volume at one second (FEV1) >70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is > 0.7)
- No known respiratory disease
Key exclusion criteria (9 listed)
- The subject has an extensive neoplastic disease
- The subject has another active lung disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
- The subject has had a recent psychiatric disorder (within one year prior to inclusion and documented by a specialist consultation)
- Emergency situations (object extractions...)
- Subject consuming illicit drugs or alcohol
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 |
|---|---|---|
| Bronchial BiopsyBronchial biopsies will be performed on all subjects. | Procedure or surgery | Non-smoking controls, Severe asthma, Smokers with COPD, Smokers without COPD |
| ALI cultureAir-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen. | Other | Non-smoking controls, Severe asthma, Smokers with COPD, Smokers without COPD |
Primary outcome
Surface density of active cilia
Time frame: Day 0 + approximately 2 months of cell culture time
Surface density of active cilia
4 secondary outcomes
Cilia beating frequency
Time frame: Day 0 + approximately 2 months of cell culture time
Mucus viscosity
Time frame: Day 0 + approximately 2 months of cell culture time
Mucus elasticity
Time frame: Day 0 + approximately 2 months of cell culture time
Cilia beat orientation
Time frame: Day 0 + approximately 2 months of cell culture time
Results and safety
The study was stopped early (reason given: Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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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.
Anne Sophie Gamez, MD study director
Montpellier University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial Biopsy and ALI culture in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by University Hospital, Montpellier 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 20 inclusion and 9 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 12 Jun 2023. 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: Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.). 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?
Surface density of active cilia (time frame: Day 0 + approximately 2 months of cell culture time). 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 12 Jun 2023.