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EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2015 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01947218
First received: August 1, 2013
Last updated: August 20, 2015
Last verified: August 2015
  Purpose

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


Condition Intervention
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Procedure: bronchial biopsies Other: Determination of CO in exhaled air

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • measure the concentration of intracellular calcium [ Time Frame: 4 years ]
    induced by cigarette smoke measured by confocal microscopy using a fluorochrome (Fura-2)


Estimated Enrollment: 70
Study Start Date: July 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: smoking COPD Procedure: bronchial biopsies Other: Determination of CO in exhaled air
Experimental: smoking without COPD Procedure: bronchial biopsies Other: Determination of CO in exhaled air
No Smoking Control Procedure: bronchial biopsies Other: Determination of CO in exhaled air
Experimental: severe asthma Procedure: bronchial biopsies Other: Determination of CO in exhaled air

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ...)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947218

Contacts
Contact: pascal CHANEZ pascal.chanez@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: PASCAL chanez       pascal.chanez@ap-hm.fr   
Principal Investigator: pascal chanez         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01947218     History of Changes
Other Study ID Numbers: 2013-A00553-42
2013-14 ( Other Identifier: AP HM )
Study First Received: August 1, 2013
Last Updated: August 20, 2015

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 22, 2017