Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma

Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma - Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006572

Enrollment

Registered

2011-10-18

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

Patients with bronchial asthma aged 20 years and older (males and females, outpatients and inpatients) being treated with an ICS (at a dose equivalent to FP 200-1000 mcg/day) and salmeterol 100 mcg/day in combination (either as two separate products or one combined product) for 3 months or longer with poor or inadequate control

Interventions

budesonide/formoterol 160/4.5 mcg,2-4inhalations,twice a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Aged>=20years old 2)Patients who has diagnosed as bronchial asthma 3)Patients who has provided written consent prior to enrollment

Exclusion criteria

Exclusion criteria: 1)Patients with infections with no available effective antimicrobial drugs or with deep mycosis. 2)Patients with a history of hypersensitivity(including contact dermatitis)to any ingredient contained in budesonide/formoterol. 3)Patients with tuberculous disease 4)5)Case with the following complications -Severe liver disease -Severe renal disease 6)Planning-to-be-pregnant,pregnant or lactating patients 7)Patients who are inappropriate considered by physician.

Design outcomes

Primary

Measure	Time frame
Change of various indicators 1)Fraction of exhaled Nitric Oxide 2)Mostgraph 3)Airway resistance of interrupter method	—

Secondary

Measure	Time frame
Respiratory Function(FEV1) Improvement of ACQ(asthma control questionnaire)score Frequency of use of short-acting inhaled be-ta2 agonist(SABA) Number of adverse event	—

Countries

Japan

Contacts

Public ContactYosuke Tanaka

Chiba-Hokusoh Hospital, Nippon Medical School Department of Respiratory Medicine

yosuke-t@nms.ac.jp0476991961

Outcome results

None listed

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