Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients (RhéMuc)

June 8, 2023 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria for non smoking controls:

  • 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

Inclusion criteria for smokers without COPD:

  • 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)
  • 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)

Inclusion criteria for smokers with COPD:

  • 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)

Inclusion criteria for subjects with severe asthma:

  • 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)

Exclusion criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Non-smoking controls

Subjects in this group have never smoked and have no known lung disorders.

Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)
Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.
Other: ALI culture
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.
Experimental: Smokers without COPD

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
Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.
Other: ALI culture
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.
Experimental: Smokers with COPD

Subjects in this group are smokers or former smokers who have COPD

Intervention: Bronchial Biopsy + ALI culture
Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.
Other: ALI culture
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.
Experimental: Severe asthma

Subjects in this group are non-smokers or former (light) smokers who have severe asthma.

Intervention: Bronchial Biopsy + ALI culture
Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.
Other: ALI culture
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surface density of active cilia
Time Frame: Day 0 + approximately 2 months of cell culture time
Surface density of active cilia
Day 0 + approximately 2 months of cell culture time

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cilia beating frequency
Time Frame: Day 0 + approximately 2 months of cell culture time
The frequency at which cilia beat.
Day 0 + approximately 2 months of cell culture time
Mucus viscosity
Time Frame: Day 0 + approximately 2 months of cell culture time
The viscosity of mucus produced by cell cultures.
Day 0 + approximately 2 months of cell culture time
Mucus elasticity
Time Frame: Day 0 + approximately 2 months of cell culture time
The elasticity of mucus produced by cell cultures.
Day 0 + approximately 2 months of cell culture time
Cilia beat orientation
Time Frame: Day 0 + approximately 2 months of cell culture time
The direction in which cilia beat
Day 0 + approximately 2 months of cell culture time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne Sophie Gamez, MD, Montpellier University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL18_0222

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Clinical Trials on Bronchial Biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings