Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.

Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma. - Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008530

Enrollment

Registered

2012-07-26

Start date

2012-07-26

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

Symbicot(R) 2puff, bid Adair(R) 250 1puff,bid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients matched below. 1. Patients with bronchial asthma. 2. Age >=65 3. Informed consent sheet have already been acquired. 4. %FEV1.0 <= 80% on pulmonary function test. 5. Patient with any asthmatic symptom, needed to strengthen the therapy, if the patient have already been treated only with inhaled corticosteroid. 6. Patient with any asthmatic symptom, needed to strengthen the therapy, if the patient have already been treated with low-dose ICS/LABA compound (Symbicot(R) 2 times/day, Adair(R) 100 2 times/day). 7. Outpatient

Exclusion criteria

Exclusion criteria: 1. Contraindication to budesonide/formoterol or fluticasone /salmeterol compound. 2. High-dose ICS/LABA have already been prescribed (Symbicot(R) inhalation>=6 times/day or Adair(R) 500 inhalation). 3. Respiratory infection in last 4 weeks before enrollment. 4. Beta2 agonist in any form. 5. Systemic corticosteroid therapy in last 30 days before enrollment. 6. Any serious comorbidity. 7. Being or willing to be pregnant 8. Investigator judged as inappropriate for this study.

Design outcomes

Primary

Measure	Time frame
Difference of %FEV1.0 before and after the therapy for eight weeks.	—

Secondary

Measure	Time frame
Difference in Inspiratory flow and ACQ (Asthma Control Questionnaire) before and after the therapy for eight weeks.	—

Countries

Japan

Contacts

Public ContactHiroshi Yamamoto

Tokyo Metroporitan Geriatric Hospital Department of Respiratory Medicine

hyamamot-tky@umin.ac.jp03-3964-1141

Outcome results

None listed

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