Real-world EvaluatIon of Mepolizumab in severe Asthma achievinG on treatment clinIcal remissioN, a prospEctive study.

JRCT ID: jRCT1031230710

Registered date:15/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 15/05/2024
• Target sample size: 336
• Countries of recruitment: USA,Japan,Belgium,Japan,Canada,Japan,Spain,Japan,Italy,Japan,Poland,Japan,Germany,Japan
• Study type: Observational
• Intervention(s): This studyy is an international multi-center and applicable for the Low-Interventional Study based on EU regulation, so the title of the research topic will be described as "intervention research." However, in Japan, spirometry lung function testing, which is stated as an intervention in this study, is routinely performed in the regular practice. Because the in tervention is part of medical practice in Japan, it is considered equivalent to "non-interventional study".

Outcome(s)

• Primary Outcome: Describe the proportion of patients that achieved clinical remission at 12 months, in the principal stratum of patients adherent to NUCALA

Secondary Outcome

1. Summarize the rate of clinically significant asthma exacerbations in patients over the follow-up period, in the principal stratum of patient adherent to NUCALA
2. Describe the proportion of patients that achieved OCS sparing and 3 component clinical remission at 12 months, in the
principal stratum of patient adherent to NUCALA
3. Evaluate the change from baseline in HRQoL, in the principal stratum of patient adherent to NUCALA

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Adults aged 18 years or over
2. Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label.
3. No NUCALA use in the 6 months prior to enrollment (unless as stated in inclusion criteria 2)
4. Participants with >=60% predicted FEV1 and =<4 exacerbations per year, as confirmed by the physician
5. Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria)
6. Written informed consent
5. Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria)
6. Written informed consent

Exclude criteria

1. Investigator concerns about participant willingness to adhere to biologic treatment for any reason
2. Participants currently on mOCS or intramuscular corticosteroids
3. Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment
4. Participating in an interventional study with a treatment intervention
5. Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis)
6. Current smokers

Related Information

• Primary Sponsor: Howarth Peter
• Source(s) of Monetary Support: GlaxoSmithKline Research &amp; Development Limited,GlaxoSmithKline Research &amp; Development Limited