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An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients

An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients - A comparison of the changes in asthma control variables by budesonide versus budesonide/formoterol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006290
Enrollment
30
Registered
2011-09-15
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 group Pulmicort (200mcg) Turbuhaler one inhalation, twice daily for 24 weeks Budesonide/formoterol group Symbicort (160/4.5mcg) Turbuhaler one inhalation, twice daily for 24 weeks

Sponsors

Third Department of Internal Medicine, Wakayama Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Adult outpatient with mild persistent and moderate asthma 2)Patient with inhaled steroid naive 3)Nonsmoking patient 4)Patients who has provided written consent prior to enrollment

Exclusion criteria

Exclusion criteria: 1)Patients with a history of hypersensitivity (including contact dermatitis) to any ingredient contained in the budesonide/formoterol combination 2)Patients with infectious with no available effective antimicrobial drugs or with deep-seated mycosis 3)Patients with other respiratory illnesses (including lung cancer, tuberculosis, bronchiectasis) 4)Patients with heart failure 5)Patients who contracted a respiratory infection that could influence asthma within the last 4 weeks 6)Patients who ere treated with systemic corticosteroids in the last 4 weeks 7)Patients with RE 8)Patients with other severe diseases 9)Patients who are considered inappropriate by the physician in charge

Design outcomes

Primary

MeasureTime frame
Change from baseline (Week 0) in the airway hyperresponsiveness at Week 2, 4, 8 and 24

Secondary

MeasureTime frame
Change from baseline (Week 0) in the following clinical variables at Week 2, 4, 8 and 24 1) ACQ 2) Respiratory function 3) Exhaled nitric oxide

Countries

Japan

Contacts

Public ContactKazuto Matsunaga

Wakayama Medical University, School of Medicine Third Department of Internal Medicine

kazmatsu@wakayama-med.ac.jp

Outcome results

None listed

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