Severe AsthmaBASICNCT07856407
Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies
An observational study of Severe Asthma, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Initial assesment interwiew and Intake Interview with the Patient
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 4 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Anne PINEAU contact
About this study
Official title: Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies: A Qualitative Study
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
- Being tested
- Initial assesment interwiew, Intake Interview with the Patient
- Keywords
- biologic therapies
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial assesment interwiewOther
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.
Intake Interview with the PatientOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Simple group | Not described Receives: Other: Initial assesment interwiew; Other: Intake Interview with the Patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the initial interwiew
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start4 Jan 2027 (estimated)
- Primary completion4 Jan 2029 (estimated)
- Study completion4 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anne PINEAU, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856407
- Sponsor's protocol ID
- 49RC26_0294
- Acronym
- BASIC
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies: A Qualitative Study
- ClinicalTrials.gov ID
- NCT07856407
- Acronym / sponsor ID
- BASIC / 49RC26_0294
- Conditions
- Severe Asthma
- Keywords
- biologic therapies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 4 Jan 2029 (estimated)
- Study completion
- 4 Jan 2029 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simple group | – | Other: Initial assesment interwiew, Other: Intake Interview with the Patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial assesment interwiewA 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. | Other | Simple group |
| Intake Interview with the PatientAfter 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. | Other | Simple group |
Primary outcome
the presence of changes in the lives of people with severe asthma, which will be identified following the analysis of their circumstances.
Time frame: During the initial interwiew
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne PINEAU contact
Anne PINEAU principal investigator
University Hospital of Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne PINEAU (241353637 ext. +33, anne.pineau@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence of changes in the lives of people with severe asthma, which will be identified following the analysis of their circumstances. (time frame: During the initial interwiew). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.