- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02593279
AVAD: Asthma With Small Airways Dysfunction (AVAD)
AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Caluire-et-Cuire, France
- Cabinets de Pneumologie Liberale
-
Lyon, France, 69002
- Hospices Civils de Lyon
-
Lyon, France
- CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes
-
Pierre-Bénite, France
- HC pneumo C
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: asthma with proximal or diffuse lung damage
|
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.
|
Experimental: asthma with small airway prevailing damage
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mRNA expression levels.
Time Frame: maximum 4 weeks after the inclusion visit.
|
mRNA expression levels will be measured by microarray analysis.
|
maximum 4 weeks after the inclusion visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical asthma profile : symptoms
Time Frame: maximum 4 weeks after the inclusion visit.
|
symptoms
|
maximum 4 weeks after the inclusion visit.
|
clinical asthma profile : medical history
Time Frame: maximum 4 weeks after the inclusion visit.
|
medical history
|
maximum 4 weeks after the inclusion visit.
|
clinical asthma profile : date of start
Time Frame: maximum 4 weeks after the inclusion visit.
|
date of start
|
maximum 4 weeks after the inclusion visit.
|
clinical asthma profile : date of aggravation
Time Frame: maximum 4 weeks after the inclusion visit.
|
date of aggravation
|
maximum 4 weeks after the inclusion visit.
|
clinical asthma profile : comorbidities
Time Frame: maximum 4 weeks after the inclusion visit.
|
comorbidities
|
maximum 4 weeks after the inclusion visit.
|
clinical asthma profile : increased factors related to asthma.
Time Frame: maximum 4 weeks after the inclusion visit.
|
increased factors related to asthma.
|
maximum 4 weeks after the inclusion visit.
|
biological asthma profile :blood eosinophils
Time Frame: maximum 4 weeks after the inclusion visit.
|
blood eosinophils
|
maximum 4 weeks after the inclusion visit.
|
biological asthma profile : blood periostin
Time Frame: maximum 4 weeks after the inclusion visit.
|
blood periostin
|
maximum 4 weeks after the inclusion visit.
|
biological asthma profile : allergologic patch test
Time Frame: maximum 4 weeks after the inclusion visit.
|
allergologic patch test
|
maximum 4 weeks after the inclusion visit.
|
biological asthma profile : IgE analysis
Time Frame: maximum 4 weeks after the inclusion visit.
|
IgE analysis
|
maximum 4 weeks after the inclusion visit.
|
morphological asthma profile : Chest X Ray (tomodensitometric test).
Time Frame: maximum 4 weeks after the inclusion visit.
|
Chest X Ray (tomodensitometric test).
|
maximum 4 weeks after the inclusion visit.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: GILLES DEVOUASSOUX, Pr, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL14_0212
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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