CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)NCT01947218
EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
A study testing bronchial biopsies and Determination of CO in exhaled air in people with CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Asthma and COPD are characterized by an accelerated decline in lung function associated with incompletely reversible airflow obstruction. This could be the result of lung structural changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum of bronchial epithelium. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
- What is being tested?
- bronchial biopsies and Determination of CO in exhaled air
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2014to 7 Aug 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be given free and informed consent and signed the consent
- The patient must be a member or beneficiary of a health insurance plan
- Women and men are included (s)
- The patient is aged at least 18 years
Who cannot join
- neoplastic disease extent
- Other progressive lung disease (tuberculosis, diseases of the pulmonary interstitium, active or recent pulmonary infection.)
- Patient unstable or had experienced exacerbation in the previous month study.
- Unable to understand the nature and purpose of the study
- Not affiliated to the French social security
- Making their military or military service career
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- During periods of exclusion on another protocol
- Patients who are mentally or legally can not give consent.
- Patients with recent psychiatric disorders (less than a year).
- The illicit drugs or alcohol.
- Pregnant women, nursing mothers and women in labor;
- Women of childbearing potential without effective contraception (specified in the protocol)
- Persons deprived of their liberty by a judicial or administrative decision, hospitalized without consent and persons admitted to a health or social establishment for purposes other than research;
- Minors;
- The adults subject to a measure of legal protection or unable to consent;
- The people in emergency situations can not give consent.
- People with a cons-indication for bronchial biopsies (coagulation disorders, anticoagulation can be suspended ...)
Trial locations and contacts
1 site in 1 country.
About this study
Asthma and COPD are characterized by an accelerated decline in lung function associated with incompletely reversible airflow obstruction. This could be the result of lung structural changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the "remodeling" is characterized by mucus cells hyperplasia, overproduction of mucus, and physicochemical, biological and immunological changes. Clinically, this mucus overproduction is reported by patients as the clinical symptom called "chronic bronchitis". Generally, it develops at a bronchiolar level where it is responsible for the progression of these diseases. There is a paradox, because the intrinsic properties of mucus seem rather beneficial so fighting against it may not be really wise at long-term. Especially its defensive effect against microbial agents which remains poorly explained. Currently, no treatment aims to reduce the production of mucus and mechanisms leading to such an overproduction are poorly understood in severe asthma and COPD. The identification of new targets to treat this overproduction of mucus in COPD is therefore of major interest.
In view of current knowledge, inflammatory mediators and signal transduction leading to increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2
- Being tested
- bronchial biopsies, Determination of CO in exhaled air
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial biopsiesProcedure or surgery
Determination of CO in exhaled airOther
| Study group | Role | What they receive |
|---|---|---|
| smoking COPD | Experimental | Not described Receives: Procedure: bronchial biopsies; Other: Determination of CO in exhaled air |
| smoking without COPD | Experimental | Not described Receives: Procedure: bronchial biopsies; Other: Determination of CO in exhaled air |
| No Smoking Control | Other | Not described Receives: Procedure: bronchial biopsies; Other: Determination of CO in exhaled air |
| severe asthma | Experimental | Not described Receives: Procedure: bronchial biopsies; Other: Determination of CO in exhaled air |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the impact of cigarette smoke on the formation and composition of mucus produced by the bronchial epithelium
(physicochemical properties, protein composition and potentially beneficial role in innate immunity)
Measured: 4 years
Secondary outcomes (1)
measure the concentration of intracellular calcium
induced by cigarette smoke measured by confocal microscopy using a fluorochrome (Fura-2)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study start30 Jun 2014
- Primary completion19 Dec 2018
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947218
- Sponsor's protocol ID
- 2013-A00553-42
- Other IDs
- 2013-14
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2013
- Last updated
- 14 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
- ClinicalTrials.gov ID
- NCT01947218
- Acronym / sponsor ID
- 2013-A00553-42
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 20 Sep 2013 (estimated)
- 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.
Asthma and COPD are characterized by an accelerated decline in lung function associated with incompletely reversible airflow obstruction. This could be the result of lung structural changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the "remodeling" is characterized by mucus cells hyperplasia, overproduction of mucus, and physicochemical, biological and immunological changes. Clinically, this mucus overproduction is reported by patients as the clinical symptom called "chronic bronchitis". Generally, it develops at a bronchiolar level where it is responsible for the progression of these diseases. There is a paradox, because the intrinsic properties of mucus seem rather beneficial so fighting against it may not be really wise at long-term. Especially its defensive effect against microbial agents which remains poorly explained. Currently, no treatment aims to reduce the production of mucus and mechanisms leading to such an overproduction are poorly understood in severe asthma and COPD. The identification of new targets to treat this overproduction of mucus in COPD is therefore of major interest.
In view of current knowledge, inflammatory mediators and signal transduction leading to increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| smoking COPD | Experimental | Procedure: bronchial biopsies, Other: Determination of CO in exhaled air |
| smoking without COPD | Experimental | Procedure: bronchial biopsies, Other: Determination of CO in exhaled air |
| No Smoking Control | Other | Procedure: bronchial biopsies, Other: Determination of CO in exhaled air |
| severe asthma | Experimental | Procedure: bronchial biopsies, Other: Determination of CO in exhaled air |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be given free and informed consent and signed the consent
- The patient must be a member or beneficiary of a health insurance plan
- Women and men are included (s)
- The patient is aged at least 18 years
Key exclusion criteria (17 listed)
- neoplastic disease extent
- Other progressive lung disease (tuberculosis, diseases of the pulmonary interstitium, active or recent pulmonary infection.)
- Patient unstable or had experienced exacerbation in the previous month study.
- Unable to understand the nature and purpose of the study
- Not affiliated to the French social security
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 biopsies | Procedure or surgery | No Smoking Control, severe asthma, smoking COPD, smoking without COPD |
| Determination of CO in exhaled air | Other | No Smoking Control, severe asthma, smoking COPD, smoking without COPD |
Primary outcome
measure the impact of cigarette smoke on the formation and composition of mucus produced by the bronchial epithelium
Time frame: 4 years
(physicochemical properties, protein composition and potentially beneficial role in innate immunity)
1 secondary outcome
measure the concentration of intracellular calcium
Time frame: 4 years
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 14 Aug 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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
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 biopsies and Determination of CO in exhaled air in people with CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), 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 17 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 14 Aug 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 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?
measure the impact of cigarette smoke on the formation and composition of mucus produced by the bronchial epithelium (time frame: 4 years). 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 14 Aug 2023.