Bronchial asthma
Conditions
Interventions
SMART group Budesonide / formoterol 160/4.5 &
micro
g two inhalations bid (morning and evening) + budesonide / formoterol 160/4.5 &
g one inhalation for asthma symptom as a reliever
SFC group Salmeterol / fluticasone 50/250 &
g one inhalation bid + procaterol 20 &
g inhalation for asthma symptom as a reliever
Sponsors
Hiroshima Allergy and Respiratory Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent by the patient - Outpatient, man or woman, 20 years or older - Diagnosis of asthma - Baseline ACQ score > 0.75 - Baseline FeNO > 35 ppb - Prescribed daily use of an Inhaled Corticosteroids (ICS) for more than 12 weeks prior to the enrollment. The doses of ICS had to be 400 - 800 mcg/day of budesonide or corresponding dose of ICS - Two to six occasional use of reliever medicine per week prior to the enrollment - IOS parameters for the small airway (R5-R20) > 0.05 kPa/L/s
Exclusion criteria
Exclusion criteria: - Patients with a history of hypersensitivity (including contact dermatitis) to any ingredient contained in the study drugs - Patients with infections with no available effective antimicrobial drugs or with deep seated mycosis - Patients with tuberculosis - Patients with rhinitis needed to be treated clinically - Respiratory infection, judged by the investigator as an infection affecting the asthma, within 8 weeks prior to enrollment - Use of any beta-blocking agents (including eye-drops) - Treatment with oral, parenteral or rectal steroids within 30 days prior to enrollment - Any significant disease or disorder judged by the investigator - Current or previous with a smoking history,10 pack years or more, or smoking cessation no longer than 6 months prior to enrollment - Pregnancy, breast-feeding or planned pregnancy during the study - Suspected poor capability, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in exhaled nitric oxide concentration from before to after 8 weeks treatment | — |
Countries
Japan
Outcome results
None listed