Randomized Controlled Trial of Hydroxychloroquine Combined With Low-dose Corticosteroid in Pulmonary Sarcoidosis

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

"The reference treatment for pulmonary sarcoidosis is prolonged systemic corticosteroid therapy, which improves dyspnea, fatigue and respiratory function. However, corticosteroid therapy doesn't improve quality of life, possibly due to its adverse effects. Furthermore, in an international survey study, the first priority in treatment outcome for sarcoidosis patient was quality of life.

Hydroxychloroquine an antimalarial drug, has been shown to be effective in cutaneous and pulmonary forms of sarcoidosis but in studies with imperfect methodology. Our hypothesis is that hydroxychloroquine associated with low-dose corticosteroids improves lung function as much as ""conventional"" medium-dose corticosteroid therapy but with fewer side effects and a better quality of life in pulmonary sarcoidosis. "

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Hydroxychloroquine; Prednisone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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