AVAD: Asthma With Small Airways Dysfunction (AVAD)

January 21, 2019 updated by: Hospices Civils de Lyon

AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction

The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction.

The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.

Study Overview

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Caluire-et-Cuire, France
        • Cabinets de Pneumologie Liberale
      • Lyon, France, 69002
        • Hospices Civils de Lyon
      • Lyon, France
        • CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes
      • Pierre-Bénite, France
        • HC pneumo C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

General Inclusion Criteria:

  • man or woman
  • age ≥ 18 years
  • asthma
  • inform consent signed
  • affiliated to health insurance

Specific inclusion criteria : asthma with proximal airways obstruction GROUP

  • Maximal Voluntary Ventilation (MMV)<80%
  • MMV / Forced Vital Capacity (FVC)≤70%
  • Carbon Monoxide Transfer Coefficient (KcO)>80%

Specific inclusion criteria : asthma with small airways dysfunction GROUP

  • Maximal Voluntary Ventilation (MMV)≥80%
  • MMV / Vital Capacity(VC)>70%
  • Carbon Monoxide Transfer Coefficient (KcO)>80%

General Exclusion Criteria:

  • pregnant woman or breastfeeding
  • patient participating to other biomedical research
  • patient who have participated to other biomedical research within the past 3 months
  • patient refusing to sign the inform consent

Specific exclusion criteria :

  • Patient who stopped smoking since less than 12 months
  • Pathological state related to obstructive distal airway damage
  • Broncho-pulmonary infectious disease within the past 4 weeks
  • Solid tumor curated by chemotherapy or chest radiotherapy
  • Chronic respiratory disease
  • Asthma exacerbation within the past 3 months
  • Oral or systemic corticotherapy within the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: asthma with proximal or diffuse lung damage
symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, igE analysis, tomodensitometric test.
Experimental: asthma with small airway prevailing damage
symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, IgE analysis, tomodensitometric test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRNA expression levels.
Time Frame: maximum 4 weeks after the inclusion visit.
mRNA expression levels will be measured by microarray analysis.
maximum 4 weeks after the inclusion visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical asthma profile : symptoms
Time Frame: maximum 4 weeks after the inclusion visit.
symptoms
maximum 4 weeks after the inclusion visit.
clinical asthma profile : medical history
Time Frame: maximum 4 weeks after the inclusion visit.
medical history
maximum 4 weeks after the inclusion visit.
clinical asthma profile : date of start
Time Frame: maximum 4 weeks after the inclusion visit.
date of start
maximum 4 weeks after the inclusion visit.
clinical asthma profile : date of aggravation
Time Frame: maximum 4 weeks after the inclusion visit.
date of aggravation
maximum 4 weeks after the inclusion visit.
clinical asthma profile : comorbidities
Time Frame: maximum 4 weeks after the inclusion visit.
comorbidities
maximum 4 weeks after the inclusion visit.
clinical asthma profile : increased factors related to asthma.
Time Frame: maximum 4 weeks after the inclusion visit.
increased factors related to asthma.
maximum 4 weeks after the inclusion visit.
biological asthma profile :blood eosinophils
Time Frame: maximum 4 weeks after the inclusion visit.
blood eosinophils
maximum 4 weeks after the inclusion visit.
biological asthma profile : blood periostin
Time Frame: maximum 4 weeks after the inclusion visit.
blood periostin
maximum 4 weeks after the inclusion visit.
biological asthma profile : allergologic patch test
Time Frame: maximum 4 weeks after the inclusion visit.
allergologic patch test
maximum 4 weeks after the inclusion visit.
biological asthma profile : IgE analysis
Time Frame: maximum 4 weeks after the inclusion visit.
IgE analysis
maximum 4 weeks after the inclusion visit.
morphological asthma profile : Chest X Ray (tomodensitometric test).
Time Frame: maximum 4 weeks after the inclusion visit.
Chest X Ray (tomodensitometric test).
maximum 4 weeks after the inclusion visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: GILLES DEVOUASSOUX, Pr, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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