Asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent was signed; 2. Outpatients aged 18-70 yrs with a diagnosis of asthma (as defined by the GIAN); 3. The onset time of asthma is more than 6 months; 4. Patients had used midle to high dose ICS (Day total dose equivalent to 400ug of budesonide or its equivalent glucocorticoid) for at least 1 month before study entry; 5. Patients were enrolled if they had a pre-terbutaline forced expiratory volume in one second (FEV1) 40–80% of predicted; 6. patients had to have used as-needed medication on=4 of the last 7 days of run-in; 7. At least one severe exacerbation >2 weeks but=12 months before study entry; 8. To complete this study and all tests; 9. Have the ability to read, understand and write related materials.
Exclusion criteria
Exclusion criteria: 1. Based on clinical interviews, physical exams or screening results, participants are not eligible to participate in the study if the investigating physician believes that the participant is at risk for the study or that the results of the study are affected; 2. Smokers (current smokers who smoked in the past 12 months, regardless of package-years) or Previous smokers (no smoking for at least 12 months, a history of smoking> 5 packs / year); 3. History of drug abuse or Drug addicts; 4. Women who were pregnant or lactating or up to 6 weeks postpartum or who had stopped breastfeeding for 6 weeks. If a female participant is found to have a pregnancy at the time of an examination, the test data is excluded from the analysis; 5. The subject was involved in a study of a novel drug or any other investigational drug and was involved in a study that included invasive procedures within 3 months of the first dose or within 3 months. Participants in other studies were eligible for inclusion in the study or were required to obtain the consent of the Steering Committee; 6. The investigators concluded that subjects had a risk of not following the procedure; 7. Subjects had a recent history of mental illness leading to incapacity; 8. Subjects had upper or lower respiratory tract infections within 2 weeks (assessment should be delayed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvements in forced expiratory volume in one second; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to first severe exacerbation;ACT test;The average number of self-reported as-needed medication use; | — |
Countries
China
Contacts
Bei Jing hospital