National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype. (2ndsouffle)
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|ClinicalTrials.gov Identifier: NCT04438408|
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment|
|Asthma Chronic Severe Asthma||Other: questionaires|
The Th2 phenotype corresponds to severe asthmatic patients eligible for new subcutaneous targeted asthma therapies, which can bring about a real improvement in symptoms and quality of life. No data are available on the proportion of this patient population since the advent of biotherapies, as well as the impact on quality of life and pathway by phenotype.
The survey will be conducted using a collection of data on a dedicated questionnaire including validated questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.
The objectives of the survey are to estimate the phenotypic profile distribution of severe asthmatic patients and the proportion currently treated by biotherapies as well as the impact of the pathology on the clinical profile and quality of life of patients with severe asthma.
Investigative pulmonologists selected from university or general hospitals or from private practice will propose to their eligible patients to participate in the study. Patients informed and not opposed to participating will complete, at the end of the consultation, the dedicated questionnaire pre-filled by the pulmonologist (for the medical data required for phenotypic stratification). The questionnaires will be collected from the centers and the data centralized to establish the database. Analyzes will be done in order to stratify the populations according to their phenotype and to analyze the data globally and by subgroup.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
severe asthma patient
Adult patients (≥ 18 years) with diagnosis of severe asthma for at least 12 months
patients will answer to questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.
- Stratification of severe asthmatics in 3 phenotypes [ Time Frame: 12 months ]The severe asthmatics patients will stratified in 3 phenotypes groups: Th2 phenotype with biotherapy, Th2 phenotype without biotherapy and non-Th2 phenotype
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438408
|Contact: Alain DIDIER, Pr||05.67.77.18.50 ext +email@example.com|
|Contact: Isabelle OLIVIER, PhD||0561777051 ext +firstname.lastname@example.org|
|Toulouse, France, 31000|
|Contact: Alain Didier, Pr 05 67 77 18 30 ext +33 email@example.com|
|Contact: Isabelle OLIVIER, PhD 0561777051 ext +33 firstname.lastname@example.org|
|Principal Investigator: Alain DIDIER, Pr|
|Sub-Investigator: Laurent GUILLEMINAULT, MD|
|Principal Investigator:||Didier Alain, Pr||University Hospital, Toulouse|