Status:
UNKNOWN
Randomized Controlled Trial of Hydroxychloroquine Combined With Low-dose Corticosteroid in Pulmonary Sarcoidosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pulmonary Sarcoidosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
"The reference treatment for pulmonary sarcoidosis is prolonged systemic corticosteroid therapy, which improves dyspnea, fatigue and respiratory function. However, corticosteroid therapy doesn't impro...
Detailed Description
"Sarcoidosis is a systemic granulomatosis of unknown etiology with almost systematic pulmonary involvement. The reference treatment for pulmonary sarcoidosis is prolonged systemic corticosteroid thera...
Eligibility Criteria
Inclusion
- Age between 18-80 years old
- Pulmonary sarcoidosis meeting the diagnostic criteria form ATS 2020 AJRCCM diagnostic criteria.
- Patient with radiographic stage II (mediastinal-hilar bilateral lymphadenopathy and parenchymal involvement) or III (involvement pulmonary parenchymatous) and FVC\<80% and respiratory symptom(s) among the following: cough, dyspnea, chest pain).
- Effective contraception for women of childbearing ages
- Informed consent signed.
- Affiliation to the social security system
Exclusion
- Severe impairment requiring an immediate and urgent result and/or high doses of corticosteroids (neurological, cardiac, ophthalmic (severe uveitis with ocular sequala), laryngeal, nasosinusal, renal, severe hypercalcemia)
- Cardiomyopathy with heart failure
- Presence of other conditions that may influence respiratory function: COPD, Asthma, Obesity (BMI\>30) pulmonary fibrosis disease, pulmonary neoplasia;
- Contraindication to hydroxychloroquinehypersensitivity to active substances or to excipients, retinopathy or severe cataract, or unilateral blindness, QTc prolongation, exposure to known treatments to prolong QT)
- Tamoxifen use
- Renal insufficiency with clearance \<60ml/min
- History of retinopathy or maculopathy
- Contraindication to corticosteroid therapy (hypersensitivity of active substancies, infections and progressive virosis, glaucoma, psychotic state not controlled by treatment, live vaccine, uncontrolled diabetes mellitus and hypertension)
- Intermittent porphyria (risk of acute porphyria crisis)
- Glucose-6-Phosphate Dehydrogenase deficiency
- Seropositivity to HIV, HBV, HCV
- Systemic corticosteroid therapy or immunosuppressive therapy for at least 7 days in the previous year;
- History of treatment with hydroxychloroquine for sarcoidosis;
- Current pregnancy,
- Breastfeeding,
- Patient unable to answer questionnaires despite the presence of a caregiver.
- Patient under trustee
- Patient under legal protection
- Participation in another therapeutic interventional trial within 6 months of inclusion
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05247554
Start Date
March 1 2022
End Date
March 1 2024
Last Update
February 21 2022
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