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

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ClinicalTrials.gov Identifier: NCT04438408
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment
Asthma Chronic Severe Asthma 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. Stratification of severe asthmatics in 3 phenotypes [ Time Frame: 12 months ]
    The severe asthmatics patients will stratified in 3 phenotypes groups: Th2 phenotype with biotherapy, Th2 phenotype without biotherapy and non-Th2 phenotype



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with confirmed diagnosis of severe asthma for at least 12 months
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438408


Contacts
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Contact: Alain DIDIER, Pr 05.67.77.18.50 ext +33 didier.a@chu-toulouse.fr
Contact: Isabelle OLIVIER, PhD 0561777051 ext +33 olivier.i@chu-toulouse.fr

Locations
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France
UHToulouse Recruiting
Toulouse, France, 31000
Contact: Alain Didier, Pr    05 67 77 18 30 ext +33    didier.a@chu-toulouse.fr   
Contact: Isabelle OLIVIER, PhD    0561777051 ext +33    olivier.i@chu-toulouse.fr   
Principal Investigator: Alain DIDIER, Pr         
Sub-Investigator: Laurent GUILLEMINAULT, MD         
Sponsors and Collaborators
University Hospital, Toulouse
AstraZeneca
Investigators
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Principal Investigator: Didier Alain, Pr University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04438408    
Other Study ID Numbers: RC31/19/0285
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Severe Asthma
Th2 phenotype
Care pathway
Quality of life
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases