Bronchiectasis
Conditions
Interventions
SAOLP group:The subjects in spleen peptide group were given 4mg of lyophilized powder orally before going to bed every night for 3 months.
Placebo group:The subjects were given 4mg of placebo orally before going to bed every night for 3 months.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible to be enrolled in the study. 1. The legal agent signs the name and date of the written informed consent approved by the Institutional Review Board (IRB)/ Independent Ethics Committee (IEC); 2. The legal agent is reliable and can comply with the research protocol. The study visit or drug treatment is decided according to the researchers' judgment, and the observation cycle can be completed with the treatment; 3. The subjects had a history of bronchiectasis, acute exacerbations =1 times, chronic cough, purulent sputum coughing, wheezing and other symptoms within 1 year before enrollment; 4. Adult patients with male or female subjects (> 18) with bronchiectasis diagnosed by high-resolution computed tomography (HRCT) and at least one acute episode in the past 1 year; 5. The subjects have no other chronic airway diseases, chronic heart failure, tumors or other life-threatening diseases; 6. The subject's blood gas analysis showed no signs of respiratory failure.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will not be enrolled in this study. 1. Subjects were previously enrolled in the study or were previously treated with the drug in another study that included the drug in the study; 2. Subject < 18 years old; Pregnant women; 3. The subject has a history of chronic alcohol or drug abuse within the past 6 months; 4. In the investigator's judgment, the subject has any prior history or history of mental illness that would preclude him from participating in the study; 5. The subject is known to be allergic to any component of the study drug or control drug in the study protocol; 6. The subjects have used immune stimulants or immune compound drugs in the last 3 months; 7. The subjects were enrolled at the stage of acute exacerbation and could not cooperate to complete lung function examination; 8. The subjects had tumor, severe cardiovascular disease, liver/renal insufficiency, active tuberculosis, immune-related disease, allergic bronchopulmonary aspergillosis, and bronchiectasis associated with pulmonary fibrosis in the last 3 months; 9. The subjects with severe chronic respiratory failure need long-term non-invasive mechanical ventilation treatment; Patients with severe pulmonary heart disease; Complicated with serious diseases of other organs, such as severe coronary heart disease, uncontrolled or poorly controlled hypertension and diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with acute exacerbations; | — |
Secondary
| Measure | Time frame |
|---|---|
| symptom;Sputum smear and culture;mMRC score;FACED score;Percentage of CD8+ cells;ratio of CD4+/CD8+; | — |
Countries
China
Contacts
Public ContactSong Yuanlin
Zhongshan Hospital, Fudan University
Outcome results
None listed