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:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT06825169
Eligibility Criteria:
Inclusion Criteria:
* Age\>18 years old (including threshold), gender not limited;
* Meets the diagnosis of interstitial lung disease;
* Screening for interstitial lung disease diagnosed by pulmonary imaging within the first 6 months;
* For patients undergoing glucocorticoid therapy at the time of screening: the background treatment remained stable during the study period;
* If the patient is undergoing anti-fibrotic therapy (pirfenidone or nintedanib) at the time of screening, they must have received a stable dose for at least 4 weeks at the time of screening and plan to continue receiving this background therapy steadily after entering this study;
* Patients of childbearing age (male and female) must agree to take effective non pharmacological contraceptive measures during the trial period and within 6 months after the last use of medication:
* Voluntarily sign an informed consent form and be able to cooperate in completing research related procedures and checks.
Exclusion Criteria:
* Individuals with a history of severe allergies or allergies to the main active ingredients or excipients of the investigational drug;
* Individuals who have been hospitalized for three or more times due to acute exacerbation of ILD or other respiratory diseases within the previous year prior to screening;
* Individuals with a history of mechanical ventilation (invasive or non-invasive) within the past month prior to screening, or those currently requiring oxygen therapy (oxygen therapy duration\>15 hours/day);
* Individuals who have contracted infectious pneumonia or require intravenous anti-infective treatment within the previous month; Previous history of tuberculosis
* Patients with other serious respiratory diseases, such as asthma, those with airway obstruction (FEV1/FVC\<0.7 before using bronchodilators), and those with other clinically significant abnormalities in the lungs;
* Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone\>240 mg/day) or irregularly use systemic corticosteroids;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06825169
Study Brief:
Protocol Section:
NCT06825169