QUIDOSE. Randomized controlled trial testing the efficacy of hydroxychloroquine combined with low dose corticosteroid therapy in pulmonary sarcoidosis.

Sarcoidosis

The difference in forced vital capacity (FVC) percentage of predicted value between baseline and 6 months

General Quality of Life: Short Form 36 item (SF-36) questionnaire, Respiratory Quality of Life: St George's Respiratory Questionnaire (SGRQ), Fatigue: Score Fatigue assessment scale (FAS), Hydroxychloroquine Treatment Side Effects: digestive issues (nausea, vomiting), allergic and skin disorders, ocular effects, Corticosteroid Treatment Side Effects : weight, blood pressure, Cushingoid facies, infection episodes, sleep disorders (Pittsburgh Sleep Quality Index - PSQI), anxiety disorders (Hospital Anxiety and Depression Scale - HADS), fasting blood glucose, HbA1c, lipid profile (total cholesterol, TG, HDL-C, LDL-C), nutritional assessment when done as part of care, Treatment Adherence: GIRERD self-questionnaire, Respiratory Function: Measure of FVC, Forced Expiratory Volume in 1 second (FEV1), Carbon Monoxide Diffusing Capacity (DLCO), oxygen saturation, 6-minute walk test (6MWT). The 3-month follow-up will be aimed at assessing the patient's early respiratory progress, as is done in routine practice, Respiratory Symptoms: Dyspnea scores and scales: mMRC, Baseline and Transition Dyspnea Index (BDI-TDI), Dyspnea-12; Cough and Sputum Assessment Questionnaire (CASA-Q), Activity and flares of thoracic and extrathoracic sarcoidosis : Organ involvement assessed clinically using the Wasog sarcoidosis organ assessment instrument adapted by Bickett et al. (Score form), Response to treatment : disappearance/appearance/worsening/improvement/stability of organ involvement using the extra-Pulmonary physician Organ Severity Tool (ePOST)(11), Sarcoidosis-Disease Activity Index (S-DAI)(12), Use of immunosuppressants or increased corticosteroid dose during the study, Biological activity assessed by serum angiotensin-converting enzyme (ACE) levels, calcium, lymphocyte count in complete blood count

No related papers found yet.

France