Connective Tissue Disease- Interstitial lung Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with connective tissue diseases that meet the latest international diagnostic classification standards for corresponding diseases; 2. According to the clinical manifestations, high-resolution CT features of the chest, and the results of pulmonary function tests, the diagnosis of interstitial lung disease was confirmed; 3. Age>=18 years old; 4. Voluntarily participate in this trial, have good compliance, and have the ability to understand and sign informed consent before the study.
Exclusion criteria
Exclusion criteria: 1. Patients with known infection with human immunodeficiency virus (HIV) at the time of screening, history of lymphoproliferative disorders or malignant tumors of any organ system within the past 5 years, and history of solid organ transplantation; 2. Females who are pregnant, breastfeeding, or planning to become pregnant during the trial; 3. Those who have undergone plasmapheresis within 3 months; 4. Patients with a known history of allergy to pirfenidone and nintedanib or serious adverse reactions; or patients with known allergies to peanuts, soy, or other excipients; 5. Those who take fluvoxamine at the same time (combined with pirfenidone, it can lead to obvious drug interactions, and its clearance rate can be significantly reduced).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of lung function ( absolute decrease of FVC in predicted value = 10 % or death );Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events and serious adverse events;Lung CT changes; | — |
Countries
China
Contacts
Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology