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

NCT ID: NCT04438408

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Chronic Severe Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

severe asthma patient

Adult patients (≥ 18 years) with diagnosis of severe asthma for at least 12 months

questionaires

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionaires

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Didier Alain, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UHToulouse

Toulouse, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alain DIDIER, Pr

Role: CONTACT

05.67.77.18.50 ext. +33

Isabelle OLIVIER, PhD

Role: CONTACT

0561777051 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alain Didier, Pr

Role: primary

05 67 77 18 30 ext. +33

Isabelle OLIVIER, PhD

Role: backup

0561777051 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC31/19/0285

Identifier Type: -

Identifier Source: org_study_id