## Protocol Section
### Identification Module
**NCT ID:** NCT02593279

**Acronym:** AVAD

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 69HCL14_0212
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2017-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-01-23

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-21

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2017-07

**Type:** ACTUAL

#### Start Date
**Date:** 2016-02

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2015-11-01
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-28
**Study First Submit QC Date:** 2015-10-29
**Why Stopped:** difficulties of enrollment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- ASTHMA

**Keywords:**

- Asthma

- phenotype

- small

- airway

- proximal

- dysfunction

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 11

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

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

**Label:** asthma with proximal or diffuse lung damage

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

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

**Label:** asthma with small airway prevailing damage

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- asthma with proximal or diffuse lung damage

**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.

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

**Type:** GENETIC

#### Intervention 2

**Arm Group Labels:**

- asthma with small airway prevailing damage

**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.

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

**Type:** GENETIC

### Outcomes Module

#### Primary Outcomes

**Description:** mRNA expression levels will be measured by microarray analysis.

**Measure:** mRNA expression levels.

**Time Frame:** maximum 4 weeks after the inclusion visit.

#### Secondary Outcomes

**Description:** symptoms

**Measure:** clinical asthma profile : symptoms

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** medical history

**Measure:** clinical asthma profile : medical history

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** date of start

**Measure:** clinical asthma profile : date of start

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** date of aggravation

**Measure:** clinical asthma profile : date of aggravation

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** comorbidities

**Measure:** clinical asthma profile : comorbidities

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** increased factors related to asthma.

**Measure:** clinical asthma profile : increased factors related to asthma.

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** blood eosinophils

**Measure:** biological asthma profile :blood eosinophils

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** blood periostin

**Measure:** biological asthma profile : blood periostin

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** allergologic patch test

**Measure:** biological asthma profile : allergologic patch test

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** IgE analysis

**Measure:** biological asthma profile : IgE analysis

**Time Frame:** maximum 4 weeks after the inclusion visit.

**Description:** Chest X Ray (tomodensitometric test).

**Measure:** morphological asthma profile : Chest X Ray (tomodensitometric test).

**Time Frame:** maximum 4 weeks after the inclusion visit.

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Caluire-et-Cuire

**Country:** France

**Facility:** Cabinets de Pneumologie Liberale

**Location 2:**

**City:** Lyon

**Country:** France

**Facility:** Hospices Civils de Lyon

**Zip:** 69002

**Location 3:**

**City:** Lyon

**Country:** France

**Facility:** CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes

**Location 4:**

**City:** Pierre-Bénite

**Country:** France

**Facility:** HC pneumo C

#### Overall Officials

**Official 1:**

**Affiliation:** Hospices Civils de Lyon

**Name:** GILLES DEVOUASSOUX, Pr

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M3750

- Name: Airway Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

- Version Holder: 2024-05-24
