AVAD: Asthma With Small Airways Dysfunction

ASTHMA Clinical Trial

— AVAD  

Official title:

AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02593279
• Other study ID #: 69HCL14_0212
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ASTHMA

Intervention

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

Locations

Country	Name	City	State
France	Cabinets de Pneumologie Liberale	Caluire-et-Cuire
France	CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes	Lyon
France	Hospices Civils de Lyon	Lyon
France	HC pneumo C	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRNA expression levels.	mRNA expression levels will be measured by microarray analysis.	maximum 4 weeks after the inclusion visit.
Secondary	clinical asthma profile : symptoms	symptoms	maximum 4 weeks after the inclusion visit.
Secondary	clinical asthma profile : medical history	medical history	maximum 4 weeks after the inclusion visit.
Secondary	clinical asthma profile : date of start	date of start	maximum 4 weeks after the inclusion visit.
Secondary	clinical asthma profile : date of aggravation	date of aggravation	maximum 4 weeks after the inclusion visit.
Secondary	clinical asthma profile : comorbidities	comorbidities	maximum 4 weeks after the inclusion visit.
Secondary	clinical asthma profile : increased factors related to asthma.	increased factors related to asthma.	maximum 4 weeks after the inclusion visit.
Secondary	biological asthma profile :blood eosinophils	blood eosinophils	maximum 4 weeks after the inclusion visit.
Secondary	biological asthma profile : blood periostin	blood periostin	maximum 4 weeks after the inclusion visit.
Secondary	biological asthma profile : allergologic patch test	allergologic patch test	maximum 4 weeks after the inclusion visit.
Secondary	biological asthma profile : IgE analysis	IgE analysis	maximum 4 weeks after the inclusion visit.
Secondary	morphological asthma profile : Chest X Ray (tomodensitometric test).	Chest X Ray (tomodensitometric test).	maximum 4 weeks after the inclusion visit.