Bronchiectasis
Conditions
Interventions
Placebo group:Eucalyptus Enteric-coated Capsules Placebo Guidelines recommend airway clearance therapy
Experimental group:Eucalyptus enteric-coated capsules Guidelines recommend airway clearance therapy
Sponsors
Huadong Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years (including cut-off value) at the time of informed consent, gender is not limited; 2. For the diagnosis of bronchiectasis, refer to the 2017 European Respiratory Society Guidelines for the Management of Adult Bronchiectasis[1] and the 2021 Chinese Expert Consensus on the Diagnosis and Treatment of Bronchiectasis in Adults. Patients with bronchiectasis and clinical diagnosis of bronchiectasis (CT) findings; 3. Combined with mucus hypersecretion: accompanied by sputum viscous symptoms (sputum trait score 2-3 points, see Appendix 1 for details); The sputum trait score is defined as 0 points (pure, clear, non-viscous sputum), 1 point (a little purulent clear sputum), 2 points (purulent viscous sputum [purulent ). =2/3]); 4. The patient was in a stable phase (there was no significant change in the respiratory symptoms during the day and at night for 4 consecutive weeks, and there was no acute exacerbation of the dilation for 4 consecutive weeks); 5. At least one acute exacerbation of the expansion within 1 year (see Appendix 2 for the definition and management of the acute exacerbation). An acute exacerbation of bronchia is defined as: (1) According to the 2019 BTS Expansion Guidelines[30] definition: 3 or more of the 6 symptoms (cough, change in sputum volume, purulent sputum, dyspnea or exercise tolerance, fatigue or malaise, hemoptysis) have worsened as assessed by the clinician for more than 48 hours, and the clinician considers it to be a condition that needs to be treated; (2) In clinical practice, some patients have been treated with antibiotics despite not meeting the definition of the 2019 BTS Dilation Guidelines after comprehensive clinical evaluation, so the acute exacerbation of the proponent is also defined as a condition that the clinician believes needs to be treated with acute exacerbation, and according to the judgment of the investigator, the subject is willing and able to adjust the current treatment according to the requirements of the protocol; 6. Patients have good compliance: subjects must be willing to complete all visit assessments at the study center as required by the trial protocol; 7. Subjects can understand the purpose and risks of the study, are willing to participate in the study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who may be allergic to the trial drug (eucalyptus enteric-coated capsules) as judged by the investigator; 2. Concomitant respiratory diseases such as bronchial asthma, a-1-antitrypsin deficiency, active tuberculosis, lung cancer, sarcoidosis, interstitial lung disease, primary pulmonary hypertension, uncontrolled sleep apnea, etc.; 3. Moderate or major hemoptysis complicated by bronchiectasis 6 months before screening (hemoptysis greater than 500 mL (or more than 100mL for one hemoptysis) within 24 hours is massive hemoptysis, and 100~500 mL is moderate hemoptysis); 4. Patients who have undergone lung surgery within 6 months prior to screening; 5. Subjects with lower respiratory tract infection requiring antibiotic treatment within 4 weeks prior to screening; 6. Upper respiratory tract infection has not recovered or has been recovered for less than 14 days before screening; 7. Patients with digestive diseases (such as peptic ulcers) that may affect the oral absorption of drugs; 8. Patients with severe systemic diseases that are unstable or likely to progress, and are judged by the investigator to be unsuitable for participating in this clinical trial; 9. Females who are pregnant or breastfeeding or who plan to become pregnant during the study, or females of childbearing potential who are not using an effective method of contraception; 10. Those who have participated in other clinical trials within 3 months prior to screening, or who are currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total diary card symptom score;The incidence of acute exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| ICER for QoL-B-RSS;Physical examination;Time to first bronchiectasis acute exacerbation over the treatment period;Sputum culture positivity rates;Quality of Life - Breast - Revised Sexual Subscale Score;24-hour sputum volume;ICER for HADS;Incremental cost-effectiveness Ratio (ICER) of bronchiectasis acute exacerbation;Leicester Cough Questionnaire;Cost-effectiveness ratio (CER) of bronchiectasis acute exacerbation;CER for HADS;AE/SAE;Lung function, including forced expiratory volume in the first second (FEV1), FEV1 predicted (FEV1%), and forced vital capacity (FVC);Laboratory tests;Direct health care cost;Hospital Anxiety and Depression Scale;Modified medical research council;CER quality of life;Vital signs;Sputum purulence score;12-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactXu Jinfu
Huadong Hospital Affiliated to Fudan University
Outcome results
None listed