AVAD: Asthma With Small Airways Dysfunction

Not Applicable

Terminated

• Conditions: ASTHMA
• Interventions: Genetic: asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.; Genetic: asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.

• Registration Number: NCT02593279
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Study Start: 2016-02
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
asthma with small airway prevailing damage	asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.	-
asthma with proximal or diffuse lung damage	asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.	-

Primary Outcome Measures

Name	Time	Method
mRNA expression levels.	maximum 4 weeks after the inclusion visit.	mRNA expression levels will be measured by microarray analysis.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes; 🇫🇷 Lyon, France

Cabinets de Pneumologie Liberale; 🇫🇷 Caluire-et-Cuire, France

HC pneumo C; 🇫🇷 Pierre-Bénite, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France