To investigate the effects of budesonide/formoterol on acute anti-inflammation and lung function improvement in patients with asthma
Conditions
Interventions
budesonide/formoterol (160/4.5 ug/inhalation) 4 inhalations
budesonide/formoterol (160/4.5 ug/inhalation) 2 inhalations
turbutaline (0.5 mg/inhlation) 2 inhalations
Sponsors
Taipei Veterans General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients are 20-70 years old of either gender; 2.Patients are diagnosed as having asthma according to GINA guideline; 3.Baseline exhaled nitric oxide (eNO) ³ 40 ppb in symptomatic asthma patient; 4.Nonsmoker or current smoker with less than 10 pack/year consumption; 5.Patients are willing and able to comply with study procedures and sign informed consent
Exclusion criteria
Exclusion criteria: 1.Patients take the following medications within 3 months prior to the study enrollment: •oral or inhaled glucocorticosteroid; •anti-inflammatory treatment; 2.Patients are hypersensitive to budesonide, formoterol, terbutaline or inhaled lactose; 3.Documented evidence of any respiratory infection within 4 weeks prior to enrolment; 4.Females who are lactating or pregnant; 5.Documented evidence of malignancy; 6.Participation in any other clinical trial or using any other investigational drug within 30 days of entry to this protocol; 7.Documented evidence of significant renal function impairment, severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV), or any finding through physical examination or medical history giving reasonable suspicion of a disease or condition that might render the subject at high risk from treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of exhaled nitric oxide value, cell counts of eosinophils and inflammatory medicatiors in induced sputum from baseline (time zero) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of exhaled nitric acid, FEV1, 5-item asthma control questionnaires status from baseline to end of study (24 weeks) | — |
Countries
Asia(except Japan)
Contacts
Public ContactKang-Cheng Su
Taipei Veterans General Hospital Depart of Chest Medicine
Outcome results
None listed