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National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.

National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04438408
Acronym
2ndsouffle
Enrollment
400
Registered
2020-06-18
Start date
2020-09-01
Completion date
2021-12-01
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Chronic, Severe Asthma

Keywords

Severe Asthma, Th2 phenotype, Care pathway, Quality of life

Brief summary

The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the landscape of severe asthma is changing in the context of biotherapies. Moreover survey on care pathway and quality of life of the asthmatic severe population according to their phenotype have never been done. It is likely to bring results in a relatively fast time, results that can lead to guide the criteria collected in RAMSES a national severe asthma cohort and future research tracks of this cohort.

Detailed description

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.

Interventions

patients will answer to questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.

Sponsors

AstraZeneca
CollaboratorINDUSTRY
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosis of severe asthma for at least 12 months confirmed by a respiratory physicians and meeting the ATS / ERS definition, * Social insured patient, * Patient given the non-opposition

Exclusion criteria

* Patient participating in a therapeutic clinical trial * Patient opposing participation in this study * Patient with reading and comprehension difficulties not allowing him to complete the questionnaires

Design outcomes

Primary

MeasureTime frameDescription
Stratification of severe asthmatics in 3 phenotypes12 monthsThe severe asthmatics patients will stratified in 3 phenotypes groups: Th2 phenotype with biotherapy, Th2 phenotype without biotherapy and non-Th2 phenotype

Countries

France

Contacts

Primary ContactAlain DIDIER, Pr
didier.a@chu-toulouse.fr05.67.77.18.50
Backup ContactIsabelle OLIVIER, PhD
olivier.i@chu-toulouse.fr0561777051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026