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Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate /vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma in 4-week treatment;Open-label, randomized, parallel-group comparative study

Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate /vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma in 4-week treatment;Open-label, randomized, parallel-group comparative study - Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate /vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017042
Enrollment
30
Registered
2015-04-04
Start date
2014-06-01
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

Budesonide160 mcg/Formoterol4.5 mcg once 2 inhalation,twice daily Fluticasone furoate100 mcg /vilanterol2 mcg once 1 inhalation,once daily

Sponsors

Hiroshima Allergy and Respiratory Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient who completely fills the following criteria 1)Man or woman who is 20 years old or older at the time getting informed consent 2)Patient who is diagnosed with asthma 3)Patient who had been administered inhaled corticosteroids of medium dose at 12 weeks over the past 4)Patient who has Value of FeNO more than 35 ppb Inhaled steroids of medium dose, Budesonide(BUD)400-800 mcg/day, or, beclomethasone(BDP-HFA), fluticasone (FP-DPI,HFA), ciclesonide(CIC-HFA), mometasone(MF-DPI)is defined as a 200-400 mcg/day

Exclusion criteria

Exclusion criteria: The patient with the following exclusion criteria is not enrolled 1)Patient with the drug allergy 2)Infection in the absence of effective antimicrobial agents, patients with deep mycosis 3)Patient with tuberculous disease, or respiratory infection 4)Patient with abnormal chest X-ray image 5)Patient with respiratory disease and other respiratory infections in 8 weeks before inclusion 6)Patient is using the beta-blockers, including eye drops or patients with systemic corticosteroids to less than 30 days 7)Patient with serious complications 8)Smoking history of 10 pack years or more and with less than 6 months or by non smoking 9)Patient with pregnancy, or who hope for a pregnancy 10)Patient was deemed inappropriate research attending physician is incorporated into this study

Design outcomes

Primary

MeasureTime frame
The comparison of amount of change in FeNO with NIOXmino between baseline and after 4 weeks treatment

Secondary

MeasureTime frame
The comparison of the effect in the following background factors after 4week treatment; ACQ score Airway resistance with IOS FEV1.0 Frequency of SABA use

Countries

Japan

Contacts

Public ContactSoichiro Hozawa

Hiroshima Allergy and Respiratory Clinic Department of Respiratory medicine

hozawa@vesta.ocn.ne.jp082-568-1167

Outcome results

None listed

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