bronchial asthma
Conditions
Interventions
Thymosin a1 adjuvant therapy group:Basic treatment, and 6mg thymosin a1 subcutaneous injection 2 times a week and the course of treatment is 3 months (12 weeks)
Sponsors
Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed with bronchial asthma by GINA 2016 guideline; 2. Participants must sign the written informed consent and agree to participate in the study; 3. men or women, female participants must be menopausal or use effective methods for contraception; 4. Aged more than 18 years and less than 80 years; 5. Patients who are diagnosed with bronchial asthma first time or have a history of bronchial asthma; 6. During screening visit, symptoms of asthma are partly under control or completely not under control; 7. Restlt of reversibility of pulmonary function test: after inhaling bronchodilators, FEV1 is improved more than 12% and its absolute value is greater than 200ml.
Exclusion criteria
Exclusion criteria: 1. Pregnancy: a woman who has been pregnant or is in lactation; 2. Patients who diagnosed with chronic obstructive pulmonary disease; 3. Patients are currently being treated with beta blockers; 4. Smoking patients with a history of more than 10 packs/year; 5. Patients with acute attack of asthma during screening visit; 6. Patients who have other respiratory diseases: active pulmonary tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension and interstitial lung disease; 7. Patients who have end-stage chronic kidney disease; 8. The severe heart failure patients (New York Heart Association class IV); 9. Restlt of pulmonary function test: after inhaling bronchodilators, expected value of FEV1 is less than 60%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACQ-5 score;FEV1/expected value;AQLQ-S score;times of unscheduled visits to hospital; | — |
Secondary
| Measure | Time frame |
|---|---|
| the number of Th1 cells in peripheral blood,;serum IL-2;serum IFN-?;Peripheral blood PBMC transcription factor T-bet;The number of Th2 cells in peripheral blood;serum IL-4;serum IL-5;serum IL-13;Peripheral blood PBMC transcription factor GATA-3;The number of Treg cells in peripheral blood;serum TGF-ß;serum IL-35;Peripheral blood PBMC transcription factor FoxP3;The number of Th17 cells in peripheral blood;serum IL-17;serum IL-22;Peripheral blood PBMC transcription factor ROR?t; | — |
Countries
China
Contacts
Public ContactHao Tang
Changzheng Hospital
Outcome results
None listed