Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.

Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma. - Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006553

Enrollment

Registered

2011-10-17

Start date

2011-10-01

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

Bronchial asthma

Interventions

Budesonide/Formoterol 160/4.5mcg, two inhalations, twice a day, 8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with bronchial asthma according to Asthma Prevention and Management Guideline in Japan 2.Age of 20 years and over, Male and Female and outpatients 3.Patients who have received intermediate-dose ICS for at least 4 weeks before enrollment 4."Partly controlled" as defined according to ASthma Prevention and Management Guideline in Japan 5.Patients signed written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients who have past history of hypersensitivity(including contact dermatitis)to budesonide, formoterol, or any component of the combination 2.Patients with infectious disease and/ or deep mycosis that have no effective antimicrobial agent 3.Patients with tuberculous disease 4.Patients infected with respiratory tract infectious disease, which may affect asthma, within 2 weeks before the enrollment 5.Patients with FEV1<=50% predicted 6.Patients using beta blocker including eye drops 7.Patients who have taken systemic steroid within 30 days before the enrollment 8.Patients with clinically severe complication 9.Planning-to-be-pregnant, pregnant or lactating patients 10.Any other conditions which in the judgement of the investigator would make the patient inappropriate for study participation

Design outcomes

Primary

Measure	Time frame
Change in peripheral blood eosinophils	—

Countries

Japan

Contacts

Public ContactAkihito Hayashi

Hirosaki University Hspital Cardiology Respiratory Medicine and Nephrology

Outcome results

None listed

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