Clinical trial NCT02593279: AVAD: Asthma With Small Airways Dysfunction
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
Overall status: TERMINATED
Phase: NA
Conditions: ASTHMA
Keywords: Asthma
phenotype
small
airway
proximal
dysfunction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: mRNA expression levels.
timeFrame: maximum 4 weeks after the inclusion visit.
Secondary outcomes:
measure: clinical asthma profile : symptoms
timeFrame: maximum 4 weeks after the inclusion visit.
measure: clinical asthma profile : medical history
timeFrame: maximum 4 weeks after the inclusion visit.
measure: clinical asthma profile : date of start
timeFrame: maximum 4 weeks after the inclusion visit.
measure: clinical asthma profile : date of aggravation
timeFrame: maximum 4 weeks after the inclusion visit.
measure: clinical asthma profile : comorbidities
timeFrame: maximum 4 weeks after the inclusion visit.
measure: clinical asthma profile : increased factors related to asthma.
timeFrame: maximum 4 weeks after the inclusion visit.
measure: biological asthma profile :blood eosinophils
timeFrame: maximum 4 weeks after the inclusion visit.
measure: biological asthma profile : blood periostin
timeFrame: maximum 4 weeks after the inclusion visit.
measure: biological asthma profile : allergologic patch test
timeFrame: maximum 4 weeks after the inclusion visit.
measure: biological asthma profile : IgE analysis
timeFrame: maximum 4 weeks after the inclusion visit.
measure: morphological asthma profile : Chest X Ray (tomodensitometric test).
timeFrame: maximum 4 weeks after the inclusion visit.
Other outcomes:
Locations:
city: Caluire-et-Cuire
country: France
facility: Cabinets de Pneumologie Liberale
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Lyon
country: France
facility: CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes
city: Pierre-Bénite
country: France
facility: HC pneumo C
Study officials:
affiliation: Hospices Civils de Lyon
name: GILLES DEVOUASSOUX, Pr
role: PRINCIPAL_INVESTIGATOR
References: