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

NCT01947218 | Completed

• 2 other identifiers: 2013-A00553-422013-14
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Outcome Measures

Primary Outcomes (1)

• 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)

  4 years

Secondary Outcomes (1)

• measure the concentration of intracellular calcium

  4 years

Study Arms (4)

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

Interventions

bronchial biopsies PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: September 20, 2013
• Study Start: June 30, 2014
• Primary Completion: December 19, 2018
• Study Completion: August 7, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

FR (1)