National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.
2ndsouffle
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 5, 2020
November 1, 2020
1 year
June 16, 2020
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stratification of severe asthmatics in 3 phenotypes
The severe asthmatics patients will stratified in 3 phenotypes groups: Th2 phenotype with biotherapy, Th2 phenotype without biotherapy and non-Th2 phenotype
12 months
Study Arms (1)
severe asthma patient
Adult patients (≥ 18 years) with diagnosis of severe asthma for at least 12 months
Interventions
patients will answer to questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.
Eligibility Criteria
Adult patients with confirmed diagnosis of severe asthma for at least 12 months
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- AstraZenecacollaborator
Study Sites (1)
UHToulouse
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Alain, Pr
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 18, 2020
Study Start
September 1, 2020
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share