AVAD: Asthma With Small Airways Dysfunction

Civil Hospices of Lyon

Status: Terminated

Conditions: ASTHMA

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02593279

69HCL14_0212

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

asthma with proximal or diffuse lung damage

Active Comparator group

Treatment:

Genetic: asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.

asthma with small airway prevailing damage

Experimental group

Treatment:

Genetic: asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.