Pulmonary Sarcoidosis
Conditions
Interventions
Trade Name: PLAQUENIL*25CPR RIV 200MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Hydroxychloroquine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200
Sponsors
UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Sarcoidosis patients, with parenchymal pulmonary involvement at CXR with or without adenopathy, must have at least one of the following lung disease activity signs: physiologic abnormalities on pulmonary function testing and/or respiratory symptoms, and/or exercise-induced abnormalities. Physiologic abnormalities on pulmonary function testing will be defined as a value of less than 80% predicted of the forced vital capacity (FVC), or DLCO-SB, or PaO2 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease-Related Exclusions: Unable to understand protocol and to sign informed consent; Not suitable candidate to comply with the requirements of this study, in the opinion of the investigator; Cardiac and neurological sarcoidosis or any other organ involvement or related condition requiring high dosage GCs treatment; End stage lung disease at HRCT ; Clinical evidence of active infection; Documented exposure to beryllium; Patients with FEV1 changes after salbutamol inhalation >=20% Medical and Laboratory Exclusions: History of advanced liver cirrhosis or abnormal liver function (SGOT and/or SGPT >= 3 x upper limit of normal); History of unstable cardiac disease; Moderate to severe renal insufficiency; Poorly controlled diabetes (defined by HbA1c >=10); Pregnancy or lactation (childbearing age female must be on effective contraceptive treatment an must undergo pregnancy testing before start the treatment); A tuberculin skin test (5 I.U.) more than 5 mm; Psoriasis; Homozygous glucose-6-phosphatase deficiency; Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives; Visual field changes attributable to 4-aminoquinolines Concomitant Therapy Exclusions: Any cytotoxic/immunosuppressive agent including but not limited to GCs at dosages higher than those per protocol, azathioprine, cyclophosphamide, methotrexate, and cyclosporine; Any cytokine modulators (including but not limited to etanercept, infliximab, pentoxifylline, thalidomide); Cimetidine, Digoxin, Phenothiazines, and Methadone (in the hydroxychloroquine arm)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to determine the safety for a combination therapy with hydroxychloroquine plus low dose GCs compared to that for high dose GCs at 3 and 9 months in patients with pulmonary sarcoidosis.;Secondary Objective: The aim of the study is to determine the non-inferiority in the overall success rate for a combination therapy with hydroxychloroquine plus low dose GCs compared to that for high dose GCs at 3 and 9 months in patients with pulmonary sarcoidosis.;Primary end point(s): Bone Mineral Density. Lumbar spine (L1-L4) bone mineral density will be evaluated at the baseline and month 9 by DXA. The same instrument will be used for serial DXA studies. | — |
Countries
Italy
Outcome results
None listed