EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Primary Purpose
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bronchial biopsies
Determination of CO in exhaled air
Sponsored by
About this trial
This is an interventional other trial for CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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 ...)
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Experimental
Arm Label
smoking COPD
smoking without COPD
No Smoking Control
severe asthma
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
measure the concentration of intracellular calcium
induced by cigarette smoke measured by confocal microscopy using a fluorochrome (Fura-2)
Full Information
NCT ID
NCT01947218
First Posted
August 1, 2013
Last Updated
August 7, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01947218
Brief Title
EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Official Title
EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2014 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
August 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
smoking COPD
Arm Type
Experimental
Arm Title
smoking without COPD
Arm Type
Experimental
Arm Title
No Smoking Control
Arm Type
Other
Arm Title
severe asthma
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
bronchial biopsies
Intervention Type
Other
Intervention Name(s)
Determination of CO in exhaled air
Primary Outcome Measure Information:
Title
measure the impact of cigarette smoke on the formation and composition of mucus produced by the bronchial epithelium
Description
(physicochemical properties, protein composition and potentially beneficial role in innate immunity)
Time Frame
4 years
Secondary Outcome Measure Information:
Title
measure the concentration of intracellular calcium
Description
induced by cigarette smoke measured by confocal microscopy using a fluorochrome (Fura-2)
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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 ...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
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