Open label multicenter study: Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients.

Open label multicenter study: Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients. - Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005895

Enrollment

Registered

2011-09-10

Start date

2011-09-01

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 combination dry powder inhalation 4inh/day for 8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Asthmatic Patients using Fluticasone / salmeterol 250/50 2inh/day continually at least recent 2 months.

Exclusion criteria

Exclusion criteria: 1)Patients who used exclusion drugs within previous 4 weeks. 2) Patients who used beta-blockers within previous 4 weeks. 3)Current smoker, smoked within previous 6 months or had smoked more than 10 pack-years in the past. 4)Tachyarrhythmia 5)Patients who are considered inappropriate by physicians in charge.

Design outcomes

Primary

Measure	Time frame
Improvement of ACQ(asthma control questionnaire) score for 8 weeks using budesonide / formoterol combination	—

Secondary

Measure	Time frame
Change of various indicators as follows: 1)Fraction of exhaled Nitric Oxide 2)Asthma relevant QOL (miniAQLQ score) 3)24h Holter ECG (PVC; Premature Ventricular Contraction / heart rate) 4)Blood pressure (SBP / DBP)	—

Countries

Japan

Contacts

Public ContactToru Kadowaki

National Hospital Organization Matsue Medical Center Depertment of Pulmonary Medicine

toruyan@matsue.hosp.go.jp0852-21-6131

Outcome results

None listed

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