mediastino-pulmonary sarcoidosis MedDRA version: 20.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: PLAQUENIL
Product Name: Hydroxychloroquine
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxychloroquine
CAS Number: 118-42-3
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients =18 years and =80 years • Mediastino-pulmonary sarcoidosis meeting diagnostic criteria (ATS 2020 AJRCCM) (13). • Patients with radiographic stage II / III and FVC =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Other severe impairment of sarcoidosis requiring an immediate and urgent result and / or high doses of corticosteroids (neurological, cardiac, ophthalmic impairment (eg severe uveitis with ocular sequelae), laryngeal, nasosinus, renal, severe hypercalcemia). • Other conditions that may influence respiratory function: Chronic Obstructive Pulmonary Disease, asthma, obesity (BMI> 30), pulmonary fibrosing disease, pulmonary neoplasia. • Contraindication to hydroxychloroquine (hypersensitivity to the active substances or to one of the excipients, severe retinopathy or cataracts, or unilateral blindness, prolongation of QTc, taking of treatments known to prolong QT • Contraindication to corticosteroid therapy (hypersensitivity to the active substances or to one of the excipients, infections and active virosis, glaucoma, psychotic states not controlled by treatment, live vaccines, diabetes mellitus and uncontrolled arterial hypertension). • Seropositivity for HIV, HCV or HBV. • Patient who received systemic corticosteroid therapy or immunosuppressive therapy for at least 7 days in the previous year. • History of treatment with hydroxychloroquine for sarcoidosis. • Pregnant women. • Nursing women. • Patient under guardianship or curatorship. • Participation in an interventional therapeutic trial within 6 months before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the non-inferiority of the combination of hydroxychloroquine and low dose corticosteroids versus medium dose corticosteroid therapy in improving respiratory function at 6 months.;Secondary Objective: Demonstrate the superiority of the combination hydroxychloroquine and low dose corticosteroids versus medium dose corticosteroid therapy at 3, 6 months and 1 year on: • General quality of life • Respiratory quality of life • Fatigue • Adverse effects of treatment • Compliance with treatments Demonstrate the non-inferiority of the combination of hydroxychloroquine and low dose corticosteroids versus medium dose corticosteroid therapy at 3, 6 months and 1 year on: • Respiratory function using additional tools • Functional respiratory signs • The activity and flare-ups of thoracic and extra-thoracic sarcoidosis. ;Primary end point(s): Difference in forced vital capacity (FVC) expressed as a percentage of the theoretical between inclusion and the 6th month.;Timepoint(s) of evaluation of this end point: 6th month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • General quality of life: quality of life questionnaire Short Form 36 item (SF-36). • Respiratory quality of life: Respiratory questionnaire from Saint Georges Hospital (SGRQ). • Fatigue: Score Fatigue assessment scale (FAS) in sarcoidosis. • Adverse effects of treatment : Hydroxychloroquine: digestive disorders (nausea, vomiting), allergic and skin disorders, ocular effects. Corticosteroid therapy: measurement of weight, blood pressure, collection of the presence of cushingoid facies, infectious episodes. Assessment of sleep disorders by the Pittsburg Sleep Quality Index (PSQI) and anxiety disorders by the Hospital Anxiety and Depression Scale (HADS). Search for diabetes mellitus (fasting blood sugar, HbA1c); dyslipidemia (complete lipid profile: total cholesterol, TG, HDLc, LDLc); nutritional assessment. • Treatment compliance: questionnaire GIRERD. • Respiratory function: Measurement of FVC, of ??the maximum expired volume in 1 second (FEV1); Pulmonary Diffusion of Carbon Monoxide (DLCO); oxygen saturation; 6 minute walk test (TM6 ’). • Functional respiratory signs: Assessment of dyspnea by scores and scales: mMRC, Baseline and transition dyspnea Index (BDI-TDI), Dyspnea-12); Cough Assessment by Cough And Sputum Assessment-Questionnaire (casa-Q). • The activity and flare-ups of thoracic and extra-thoracic sarcoidosis: Evaluation of organ damage by clinical investigation, based on the tool of the Wasog sarcoidosis organ assessment instrument adapted by Bickett et al. as a score (9.10), Response to treatment: Disappearance / onset / worsening (flare) / improvement / stability of various organ damage by the extraPulmonary physician Organ Severity Tool (ePOST) (11) Sarcoidosis-Disease Activity Index (S-DAI) (12), Use during the study of immunosuppressive therapy or increased corticosteroid therapy, Biological activity assessed by serum angiotensin converting enzyme (ACE) assay (x N and IU / l), serum calcium, concentration of lympho | — |
Countries
France
Contacts
Public ContactDRCI - Hôpital Saint-Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Outcome results
None listed