Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT03643302
Eligibility Criteria:
Inclusion Criteria:
* Willing to join in and sign the informed consent form;
* The diagnosis of bronchiectasis need reference to the definition of "European Respiratory Society guidelines for the management of adult bronchiectasis." published by the european respiratory journal in 2017, defined by the presence of both permanent bronchial dilatation on computed tomography (CT) scanning and the clinical syndrome of cough, sputum production and/or recurrent respiratory infections;
* Pulmonary exacerbation in patients with bronchiectasis was required to meet three or more of the following key symptoms for at least 48h: Cough; Sputum volume and/or consistency; Sputum purulence; Breathlessness and/or exercise tolerance; Fatigue and/or malaise; Haemoptysis, and a clinician determines that a change in bronchiectasis treatment is required;
* According to the researchers, the subjects were willing and able to follow the protocol and were able to tolerate bronchoscopy;
* Patients with good compliance: the subject must be willing to follow the test plan requirements in the research center to complete all the assessment of the visit.
Exclusion Criteria:
* Pregnant or lactating women;
* Hypogammaglobulinemia or other autoimmune diseases;
* Clinical diagnosis of ABPA;
* Non tuberculosis mycobacteria positive 2 years before;
* Allergies or allergic to a variety of drugs;
* Poor compliance or can not cooperate judged by doctors;
* Participated in other clinical trials for nearly three months;
* The researchers considered that the subject had other circumstances that were unfit to attend;
* Suffering from a significant disease or condition outside of bronchiectasis, as judged by the researchers, may lead to subjects at risk due to participate in the study,or the disease that have an impact on the research result and the ability of subjects to participate in this study;
* Bronchoscopy contraindication;
* Patients with heart, liver and kidney, nervous system, endocrine and other systemic diseases, may not be able to adhere to the completion of the study, or will affect the research process;
* Patients who refused to sign informed consent after targeted explanation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03643302
Study Brief:
Protocol Section:
NCT03643302