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Stepping Down LAMA from Triple Therapy in Adult Asthma Patients

Stepping Down LAMA from Triple Therapy in Adult Asthma Patients - Stepping Down LAMA from Triple Therapy in Adult Asthma Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058333
Enrollment
60
Registered
2025-07-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult asthma

Interventions

withdrawing LAMA from ICS/LABA/LAMA therapy

Sponsors

Yamanashi Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients attending the outpatient internal medicine clinic of Yamanashi Red Cross Hospital between August 1, 2025, and July 31, 2026, will be screened. Eligible patients are those aged 18 years or older who have been diagnosed with asthma according to the 2024 Asthma Prevention and Management Guidelines, and who meet all of the following criteria within 28 days prior to Visit 1, with the ability to provide written informed consent: 1 Have been receiving ICS/LABA/LAMA therapy for at least 6 months 2 Have an Asthma Control Test (ACT) score >2 3 Have had no asthma exacerbation in the past year (regardless of severity), defined as any of the following: treatment with oral or systemic corticosteroids, emergency department visits, or hospitalization 4 Have had no use of oral corticosteroids as maintenance therapy within the past year

Exclusion criteria

Exclusion criteria: 1 asthma COPD overlap diagnosed according to the Guidelines for the Diagnosis and Treatment of Asthma COPD Overlap 2nd edition 2 Cough variant asthma 3 Unable to provide written informed consent

Design outcomes

Primary

MeasureTime frame
rate of asthma exacerbations

Secondary

MeasureTime frame
Median time to asthma exacerbation Change from baseline in FEV1 and FEV1 predicted Change from baseline in ACT score Change from baseline in FeNO Change from baseline in blood eosinophil count Univariate analysis of baseline characteristics between patients with and without asthma exacerbation Univariate analysis of the association between asthma exacerbation and checklist items related to airway hyperresponsiveness

Countries

Japan

Contacts

Public ContactYosuke Fukuda

Yamanshi Red Cross Hospital Department of Medicine, Division of Respiratory Medicine

yosukefukuda.showa@gmail.com+81-555-72-2222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026