mild asthma
Conditions
Interventions
Group A:one inhalation of Pulmicort Turbuhaler 200 ug/inhalation
Group B:Oxis Turbuhaler 4.5 ug/inhalation with symptom-driving
Group C:Symbicort Turbuhaler 160/4.5 ug/inhalation with symptom-driving
Sponsors
1st Affiliated Hospital of SYSU
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: For inclusion in the study run-in period, patients must fulfill all of the following criteria at Visit 1: 1. Provision of informed consent. The signed and dated informed consent must have been obtained before conducting any study-related procedures; 2. Outpatients with a diagnosis of mild asthma; Either sex, >=18 years of age; 3. A history of at lease 3 months asthma according to American Thoracic Society (ATSl987); 4. Before-bronchodilatory FEV1>=50% of normal predicted value; 5. Reversible airway obstruction is FEVl increases >=12% compared with baseline, while to patients >=18 years of age, FEVl>=200ml is required; 6. Before Visit 1, ICS ranges as follows: -200-400 ug budesonide, or equivalent dose, complicating LABA; -400-800 ug budesonide, or equivalent dose, without complicating LABA; 7. At least one episode of AE-asthma must have been observed 3-6 months before inclusion.
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Known or suspected hypersensitivity to study medications or adjuvant; 2. Other severe respiratory disease which influences asthma before visit 1; 3. Use of oral, rectal, parenteral GC (30 Days before inclusion). 4. Use of any beta-blocking agent, including eye-drops; 5. A history of smoking >=10 pack-years (one pack-year = one pack (20 cigarettes) per day for one year or equivalent); 6. Pregnancy, breast-feeding, or planned pregnancy during the study; 7. Any other significant disease or disorder (eg, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, either put the patient at risk because of participating in the study or may influence the results of the study, or the patient's ability to participate in the study; 8. Any clinically significant abnormal finding in biochemical indicators, blood routine, urine routine, ECG, physical examination or vital signs at Visit 1; 9. Suspected poor capability, as judged by the investigator, to follow instructions of the study, eg, because of a history of alcohol or drug abuse; 10. Planned in-patient hospitalisation during the course of the study; 11. Participating in this study (including Astrazeneca researcher) 12. Participating in another clinical study during the course of this study or within 30 days prior to Visit 1; 13. Have relevant asthma therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To the time the first serious asthma exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of mild asthma exacerbations;Pulmonary function:FEV1, PEF;The number of severe asthma exacerbations;To the time the first mild asthma exacerbation; | — |
Countries
China
Contacts
Public ContactCanmao Xie
Outcome results
None listed