Asthma
Conditions
Interventions
Control group:One vial of placebo, intramuscular injection, once a week for 12 weeks as one course of treatment
Experiment group:One vial of M.vaccae, intramuscular injection, once a week for 12 weeks as one course of treatment
Sponsors
Shanghai ChangZheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years, non-limited gender; 2. Patients diagnosed with asthma and reversible airway obstruction, which means FEV1 improvement >=15% or FEV1 increased >=200ml 15 minutes after inhaling beta2 receptor agonist (Ventolin) or bronchial provocation test (+); 3. No systemic medication of anti-inflammatory and anti-allergic drugs including corticosteroid, Ketofifen or Montelukast in one month; 4. Never participated in the other clinical trials in recent 3 months; 5. Urine pregnant test is negative in women of reproductive age 48 hours before therapy who agreed to take contraceptive measure.
Exclusion criteria
Exclusion criteria: 1. Allergic to this drug; 2. Pregnant or breast-feeding women; 3. Oral intake of corticosteroid needed everyday; 4. FEV1 account for predicted value =2mg/dl or >=177umol/l), or severe cardiac, hematological disease; 7. Incorporated in Psychological state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of asthma aggravation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of scores of clinical presentations before and after treatment;Changes of doses of beta2 receptor agonist (Ventolin) before and after treatment;Changes of FEV1 and PEF before and after treatment; | — |
Countries
China
Contacts
Public ContactQingyu Xiu
Outcome results
None listed