TIPS : Immunomodulatory Treatment of Interstitial Lung Disease Associated with Surfactant related Gene Mutations

Conditions

Interstitial Lung Disease

Brief summary

Difference in forced vital capacity decline between the 2 groups at one year

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGPREDNISOLONE

DRUGPREDNISONE

DRUGAZITHROMYCIN

DRUGHYDROXYCHLOROQUINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference in forced vital capacity decline between the 2 groups at one year	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed