Study objective: To evaluate the 5-year prognosis ofpatients with stage I and stage II newly detected (< 3 months)pulmonary sarcoidosis treated immediately after diagnosis withprednisolone for 3 months followed by inhaled budesonide for 15months.
Design: Randomized, double-blind,placebo-controlled, parallel-group study for 18 months. Thereafter,open follow-up without treatment.
Setting: Twentypulmonary medicine departments in Finland.
Patients:One hundred eighty-nine adult patients, most of them with normal lungfunction, were randomized to treatment. One hundred forty-nine patientswere followed up for 5 years: 79 patients with initial stage I diseaseand 70 patients with stage II disease.
Treatment: Oralprednisolone for 3 months followed by inhaled budesonide for 15 months(800 μg bid), or placebo tablets followed by placebo inhaler therapy.Thereafter, treatment only on an individual basis in the case ofclinical deterioration.
Measurements: Yearly follow-upvisits with chest radiographs, lung function tests (FEV1,FVC), diffusion capacity of the lung for carbon monoxide(Dlco), serum angiotensin-converting enzyme (SACE), andserum and urinary calcium measurements.
Results: Noinitial differences were observed in chest radiographic findingsbetween the active-treatment and placebo-treatment groups, either inpatients with initial stage I or stage II(-III) disease. However, afterthe 5-year follow-up, 18 steroid-treated patients (26%) and 30placebo-treated patients (38%) still had remaining chest radiographicchanges. Placebo-treated patients more frequently required treatmentwith corticosteroids during the 5-year follow-up (p < 0.05).Steroid-treated patients with initial stage II(-III) disease improvedmore in FVC and Dlco (p < 0.05). No differences inreported adverse events or in SACE, serum calcium, or urinary calciumvalues were seen.
Conclusion: Immediate treatment ofpulmonary stage II(-III) sarcoidosis—but not stage I disease—improvedthe 5-year prognosis with regard to lung functionvariables.