National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype. (2ndsouffle)

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.

Study Overview

• Status: Unknown
• Conditions: Severe Asthma; Asthma Chronic
• Intervention / Treatment: Other: questionaires

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Alain DIDIER, Pr; Phone Number: +33 05.67.77.18.50; Email: didier.a@chu-toulouse.fr
• Study Contact Backup: Name: Isabelle OLIVIER, PhD; Phone Number: +33 0561777051; Email: olivier.i@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • UHToulouse
    • Contact: Isabelle OLIVIER, PhD; Phone Number: +33 0561777051; Email: olivier.i@chu-toulouse.fr
    • Contact: Alain Didier, Pr; Phone Number: +33 05 67 77 18 30; Email: didier.a@chu-toulouse.fr
    • Sub-Investigator: Laurent GUILLEMINAULT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with confirmed diagnosis of severe asthma for at least 12 months

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
severe asthma patient; Adult patients (≥ 18 years) with diagnosis of severe asthma for at least 12 months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Didier Alain, Pr, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Severe Asthma; Th2 phenotype; Care pathway
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: RC31/19/0285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No