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

Severe Asthma Clinical Trial

— 2ndsouffle  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438408
• Other study ID #: RC31/19/0285
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: Alain DIDIER, Pr
• Phone: 05.67.77.18.50
• Email: didier.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Chronic
• Severe Asthma

Intervention

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

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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