Skip to main content
OpenTrials
Completed

NCT Number: NCT01947218

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ...)

Treatment and study plan

bronchial biopsies

Procedure

Determination of CO in exhaled air

Other

Primary outcomes

  1. 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 outcomes

  1. measure the concentration of intracellular calcium

    Time frame: 4 years

    induced by cigarette smoke measured by confocal microscopy using a fluorochrome (Fura-2)

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2023
First posted
Sep 20, 2013
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.