Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies

NCT07856407 | Not Yet Recruiting

• 1 other identifier: 49RC26_0294
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Severe asthma is a debilitating disease that affects every aspect of patients' lives: daily life, work, social life, family life, and marital life. The advent of biologic therapies has transformed these patients' quality of life by improving asthma control, access to care, and overall quality of life. But how do patients actually experience this transformation in their lives? What has actually changed for them, based on their own perceptions? Investigator hypothesize that a hypothetical-deductive qualitative study with a methodology focused on each patient's individual situation will allow to better explore the changes that have occurred in these patients' lives. The BASIC Study aims to understand, through semi-structured interviews, how the lives of patients on biologic therapy have evolved. Patient therapeutic education is an integral part of the care provided to patients with severe asthma in the Pulmonology Department at Angers University Hospital. This therapeutic education is truly centered on patients' needs thanks to a methodology designed to reveal units of meaning. The BASIC study will employ the same methodology to analyze patients' life situations in order to better understand the changes they perceive while on biologic therapy, as well as their new educational needs. The results would make it possible to assess the qualitative effectiveness of biologic therapies from a unique patient-centered perspective, as well as to identify new educational needs among these patients. Thus, the current therapeutic education program could be enhanced.

Conditions

Severe Asthma

Keywords

biologic therapies

Outcome Measures

Primary Outcomes (1)

• the presence of changes in the lives of people with severe asthma, which will be identified following the analysis of their circumstances.

  to analyze changes in the living conditions of patients with severe asthma who have been receiving targeted therapy for at least 6 months, using a person-centered methodology.

  During the initial interwiew

Study Arms (1)

Simple group

Other: Initial assesment interwiew; Other: Intake Interview with the Patient

Interventions

Initial assesment interwiew OTHER

A semi-structured interview lasting about one hour, conducted in an environment designed to put the patient at ease. First, an exploration of the changes that occurred in the patient's life prior to immunotherapy across all aspects of daily life-including social, professional, family, and marital life. Second, an exploration of current difficulties related to the illness while on immunotherapy, and the coping strategies the patient has implemented in various areas of life.

Simple group

Intake Interview with the Patient OTHER

After two professionals have reviewed the initial double-blind interview, the purpose of this second interview is to confirm with the patient that they have a clear understanding of his or her situation and needs.

Simple group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe asthma who have been on biologic therapy for at least 6 months and are being treated at the Angers University Hospital's Pulmonology Department

You may qualify if:

• Adult patients.
• Patients with severe asthma who have been receiving targeted therapy (with omalizumab, benralizumab, mepolizumab, dupilumab, or tezepelumab) for at least 6 months, with no upper limit on the duration of treatment.
• Able to understand the informed consent form and willing to consent to participate in a recorded semi-structured interview, as well as to the anonymized processing of their data.

You may not qualify if:

• Any person
• Who refuses to participate in the research.
• Who is unable to travel to participate in an in-person interview.
• Who is under legal guardianship or conservatorship.
• Who does not speak French.
• Who has asthma associated with a systemic disease (GEPA, ABPA, etc.).

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Anne PINEAU

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne PINEAU

CONTACT

241353637; anne.pineau@chu-angers.fr

Anne PINEAU

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): January 4, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09