Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol (160/4.5 mcg) fixed dosing (4 inhalations daily) and adjustable maintenance dosing (2 to 8 inhalations daily) in poorly controlled adult asthma patients

Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol (160/4.5 mcg) fixed dosing (4 inhalations daily) and adjustable maintenance dosing (2 to 8 inhalations daily) in poorly controlled adult asthma patients - Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol fixed dosing and adjustable maintenance dosing in poorly controlled adult asthma patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006056

Enrollment

Registered

2011-08-01

Start date

2011-08-01

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

Bronchial asthma

Interventions

Treatment with budesonide/formoterol (160/4.5 mcg) for 12 weeks, one to four inhalations, twice daily, dose is adjusted every 2 weeks if necessary Treatment with budesonide/formoterol (160/4.5 mcg) fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with FEV1>= 60% predicted - Patients who have received ICS for at least 4 weeks before enrollment - Patients with average ACQ score >= 0.75

Exclusion criteria

Exclusion criteria: - Patients who have past history of hypersensitivity (including contact dermatitis) to budesonide, formoterol, or any component of the combination - Patients with infectious disease and/or deep mycosis that have no effective antimicrobial agent - Patients with tuberculous disease - Patients infected with influenza virus and/or lower respiratory tract infectious disease, which may affect asthma, within 2 weeks before the enrollment - Patients using beta blocker including eye drops - Patients who have taken systemic steroid within 2 week before the enrollment - Patients with moderate to severe COPD classified with Global Initiative for Chronic Obstructive Lung Disease (moderate COPD: FEV1/FVC < 0.70, 50%<= FEV1<80% predicted) - Current smoker - Patients with clinically severe complication - Planning-to-be-pregnant, pregnant or lactating patients

Design outcomes

Primary

Measure	Time frame
Change of the Asthma Control Questionnaire score	—

Secondary

Measure	Time frame
- Respiratory function (FEV1) - Total dose of budesonide/formoterol - Mini Asthma Quality of Life Questionnaire score - Number of adverse event	—

Countries

Japan

Contacts

Public ContactYukio Nagasaka

Sakai Hospital, Kinki University School of Medicine General Internal Medicine

nagasaka@sakai.med.kindai.ac.jp072-299-1120

Outcome results

None listed

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