2026-525336-41-00招募中2 期
TIPS : Immunomodulatory Treatment of Interstitial Lung Disease Associated with Surfactant related Gene Mutations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Difference in forced vital capacity decline between the 2 groups at one year
研究概览
简要总结
Evaluate the efficacy of triple immunomodulatory therapy (prednisone, azithromycin and hydroxychloroquine) for 12 months in patients with ILD associated with a variant of a surfactant-related gene.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and <80 years
- •Carrier of a variant classified as pathogenic or probably pathogenic or considered as eligible by the genetic multidisciplinary discussion in SFTPA1, SFTPA2, SFTPC, NKX2-1, SFTPB or two variants classified as pathogenic or probably pathogenic or considered as eligible by the genetic multidisciplinary discussion in ABCA3 or SFTPB
- •ILD whatever the pattern corresponding to a volume > 10% of the total lung on a CT scan of less than 2 years
排除标准
- •Contraindication to azithromycin and hydroxychloroquine and prednisone
- •Pregnancy and breastfeeding
- •Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)
- •Subject deprived of liberty or subject under legal protection measure
- •No affiliation to any health insurance system
研究组 & 干预措施
AZITHROMYCIN
Test
干预措施: AZITHROMYCIN (Drug)
PREDNISOLONE
Test
干预措施: PREDNISOLONE (Drug)
PREDNISONE
Test
干预措施: PREDNISONE (Drug)
HYDROXYCHLOROQUINE
Test
干预措施: HYDROXYCHLOROQUINE (Drug)
结局指标
主要结局
Difference in forced vital capacity decline between the 2 groups at one year
Difference in forced vital capacity decline between the 2 groups at one year
次要结局
- Clinical and biological tolerance (occurrence of an adverse effect during treatment), ECG (at 3, 6, 9, 12 months after randomization) (only HCQ or AZI patients) and ophthalmological (at one year after randomization)
- Thoracic CT scan and PFT at 6 months and one year after randomization
- Quality of life questionnaire (EORTC QLQ-C30, v3.0) at 3 months, 6 months, 9 months and one year after randomization,
- Collection of vital status, lung transplantation, hospitalization for pulmonary and non-pulmonary causes and episodes of exacerbation at each visit until the end of follow-up 12 months after randomization
研究者
Coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (4)
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