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AVAD: Asthma With Small Airways Dysfunction (AVAD)

Primary Purpose

ASTHMA

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.
asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ASTHMA focused on measuring Asthma, phenotype, small, airway, proximal, dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinets de Pneumologie Liberale
  • Hospices Civils de Lyon
  • CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes
  • HC pneumo C

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

asthma with proximal or diffuse lung damage

asthma with small airway prevailing damage

Arm Description

Outcomes

Primary Outcome Measures

mRNA expression levels.
mRNA expression levels will be measured by microarray analysis.

Secondary Outcome Measures

clinical asthma profile : symptoms
symptoms
clinical asthma profile : medical history
medical history
clinical asthma profile : date of start
date of start
clinical asthma profile : date of aggravation
date of aggravation
clinical asthma profile : comorbidities
comorbidities
clinical asthma profile : increased factors related to asthma.
increased factors related to asthma.
biological asthma profile :blood eosinophils
blood eosinophils
biological asthma profile : blood periostin
blood periostin
biological asthma profile : allergologic patch test
allergologic patch test
biological asthma profile : IgE analysis
IgE analysis
morphological asthma profile : Chest X Ray (tomodensitometric test).
Chest X Ray (tomodensitometric test).

Full Information

First Posted
October 28, 2015
Last Updated
January 21, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02593279
Brief Title
AVAD: Asthma With Small Airways Dysfunction
Acronym
AVAD
Official Title
AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
difficulties of enrollment
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ASTHMA
Keywords
Asthma, phenotype, small, airway, proximal, dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
asthma with proximal or diffuse lung damage
Arm Type
Active Comparator
Arm Title
asthma with small airway prevailing damage
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.
Intervention Description
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.
Intervention Type
Genetic
Intervention Name(s)
asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.
Intervention Description
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.
Primary Outcome Measure Information:
Title
mRNA expression levels.
Description
mRNA expression levels will be measured by microarray analysis.
Time Frame
maximum 4 weeks after the inclusion visit.
Secondary Outcome Measure Information:
Title
clinical asthma profile : symptoms
Description
symptoms
Time Frame
maximum 4 weeks after the inclusion visit.
Title
clinical asthma profile : medical history
Description
medical history
Time Frame
maximum 4 weeks after the inclusion visit.
Title
clinical asthma profile : date of start
Description
date of start
Time Frame
maximum 4 weeks after the inclusion visit.
Title
clinical asthma profile : date of aggravation
Description
date of aggravation
Time Frame
maximum 4 weeks after the inclusion visit.
Title
clinical asthma profile : comorbidities
Description
comorbidities
Time Frame
maximum 4 weeks after the inclusion visit.
Title
clinical asthma profile : increased factors related to asthma.
Description
increased factors related to asthma.
Time Frame
maximum 4 weeks after the inclusion visit.
Title
biological asthma profile :blood eosinophils
Description
blood eosinophils
Time Frame
maximum 4 weeks after the inclusion visit.
Title
biological asthma profile : blood periostin
Description
blood periostin
Time Frame
maximum 4 weeks after the inclusion visit.
Title
biological asthma profile : allergologic patch test
Description
allergologic patch test
Time Frame
maximum 4 weeks after the inclusion visit.
Title
biological asthma profile : IgE analysis
Description
IgE analysis
Time Frame
maximum 4 weeks after the inclusion visit.
Title
morphological asthma profile : Chest X Ray (tomodensitometric test).
Description
Chest X Ray (tomodensitometric test).
Time Frame
maximum 4 weeks after the inclusion visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GILLES DEVOUASSOUX, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinets de Pneumologie Liberale
City
Caluire-et-Cuire
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Name
CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes
City
Lyon
Country
France
Facility Name
HC pneumo C
City
Pierre-Bénite
Country
France

12. IPD Sharing Statement

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AVAD: Asthma With Small Airways Dysfunction

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