TERESA study (TERESA study)

Phase 4

• Conditions: uncontrolled severe asthma

• Registration Number: JPRN-jRCTs071230026
• Lead Sponsor: Okamoto Isamu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1.Patients diagnosed with severe asthma by a respiratory physician and receiving middle- or high-dose inhaled glucocorticoids plus additional controller medication. (Patients treated with or without a history of biologics use, however, as long as possible more than 4 months elapsed between the last dose of the previous biological agent and the start of protocol treatment.)
2.Patients treated with systemic corticosteroids as maintenance therapy for asthma at a PSL equivalent of 5 mg/day or less.
3.Patients aged 20 years or older at the time of obtaining consent.
4.Patients with uncontrolled asthma who fulfill one of the following conditions.
i) History of at least one asthma exacerbation within 6 months before the date of obtaining consent
ii) 1.5< Asthma Control Questionnaire-6 (ACQ-6) score <=3.5 within 2 months before the date of consent
iii) 60% predicted <= FEV1 <80% predicted within 2 months before the date of obtaining consent
5.Patients who are able to provide informed written consent prior to enrolment in the study.

Exclusion Criteria

1. Patients diagnosed with any clinically significant pulmonary diseases other than asthma (e.g., chronic obstructive pulmonary disease) or pulmonary or systemic diseases due to increased peripheral blood eosinophil counts (e.g., chronic eosinophilic pneumonia, allergic bronchopulmonary mycosis, eosinophilic granulomatosis with polyangiitis).
2. Patients diagnosed with a parasitic infection within 6 months before obtaining consent who were not treated with standard treatment or who did not respond to treatment.
3. Patients with comorbidities requiring systemic corticosteroids or immunosuppressive treatment.
4. Patients with a history of anaphylaxis or immune complex disease (type III hypersensitivity reaction) following treatment with biological agents.
5. Female patients who are pregnant or may become pregnant. Female patients who are lactating.
6. Patients deemed by the responsible physician to be unsuitable for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified