asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Sub Study 1: 1. 18-60 years old; 2. Without ICS treatment or asthma patients use low dose ICS (FP = 500ug/d) did not reach the control 4 weeks ago; 3. FEV1 accounted for the expected value 40-90%, within 3 months of diastolic test positive (inhalation of salbutamol 400 g FEV1 improvement rate was higher than 12%, and the increase is greater than or equal to 200ml) or bronchial provocation test positive; 4. the screening period within 7 days after the diurnal or nocturnal asthma symptoms (wheezing, shortness of breath, chest tightness or cough) over 3 days; 5. patients have the ability to fill in the diary card, AQLQ, ACT score, the proper use of peak flow meter and the study of drug; 6. agreed to participate in the study and signed the informed consent of patients. Sub Study 2: 1. 18-60 years old; 2. consistent with the diagnosis of acute exacerbation of asthma, and the assessment of the severity of severe acute exacerbation of asthma patients belong to; 3. patients have the ability to fill in the diary card, AQLQ, ACT score, the proper use of peak flow meter and the study of drug; 4. agreed to participate in the study and signed the informed consent of patients. Sub Study 3: 1. 18-60 years old; 2. consistent with the diagnosis of asthma; 3. patients have the ability to fill in the diary card, ACT score, the proper use of peak flow meter and asthma diary; 4. agreed to participate in the study and signed the informed consent of patients.
Exclusion criteria
Exclusion criteria: Sub Study 1: 1. have serious heart and lung diseases, COPD, digestive ulcer history; 2. within screening 8 weeks, had respiratory tract infection; 3. within screening 6 weeks, used systemic glucocorticoid; 4. screening period cannot be disabled inhaled anticholinergic drugs, oral and inhaled long-acting beta 2 agon-ists as well as in the treatment period cannot be disabled leukotriene receptor antagonist and anti histamine drug therapy; 5. known or suspected of theophylline, ICS, beta 2 agonists allergy or contraindication; 6. pregnancy, planned pregnancy or lactating women; 7. current or former smokers, smoking history more than 10 pack years; 8. blood routine, urine routine, blood biochemical abnormalities; alanine aminotransferase / aspartate aminotransferase (ALT/AST) exceeds the upper limit of normal 2 times greater than 1.5 times the upper limit of normal serum bilirubin, serum creatinine greater than 1.2 times the upper limit of normal; 9. patients in the 1 months before the screening period in 6 half lives of other clinical research or the research study on the washout period is still in a drug, whichever is longer; 10. clear seasonal, occupational asthma or by explicitly induced factors caused can not be divorced from the inducing factors of patients. Sub study 2: 1. have serious heart and lung diseases, COPD, digestive ulcer history; 2. within screening 6 weeks,used systemic glucocorticoid; 3. known or suspected allergy to theophylline and beta 2 agonists and accessories or contraindication; 4. Pregnancy, pregnant or lactating women; 5. current or former smokers, smoking history more than 10 pack years; 6. blood routine, urine routine, blood biochemical abnormalities; alanine aminotransferase / aspartate aminotransferase (ALT/AST) exceeds the upper limit of normal 2 times greater than 1.5 times the upper limit of normal serum bilirubin, serum creatinine greater than 1.2 times the upper limit of normal; 7. patients in the 1 months before the screening period in 6 half lives of other clinical research or the research study on the washout period is still in a drug, whichever is longer. Sub study 3: No.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Control rate of asthma;Time of remision; | — |
Countries
China