pulmicort and Sarcoidosis--Pulmonary

To evaluate the 5-year prognosis of patients with stage I and stage II newly detected (< 3 months) pulmonary sarcoidosis treated immediately after diagnosis with prednisolone for 3 months followed by inhaled budesonide for 15 months.. Randomized, double-blind, placebo-controlled, parallel-group study for 18 months. Thereafter, open follow-up without treatment.. Twenty pulmonary medicine departments in Finland.. One hundred eighty-nine adult patients, most of them with normal lung function, were randomized to treatment. One hundred forty-nine patients were followed up for 5 years: 79 patients with initial stage I disease and 70 patients with stage II disease.. Oral prednisolone for 3 months followed by inhaled budesonide for 15 months (800 microg bid), or placebo tablets followed by placebo inhaler therapy. Thereafter, treatment only on an individual basis in the case of clinical deterioration.. Yearly follow-up visits with chest radiographs, lung function tests (FEV(1), FVC), diffusion capacity of the lung for carbon monoxide (DLCO), serum angiotensin-converting enzyme (SACE), and serum and urinary calcium measurements.. No initial differences were observed in chest radiographic findings between the active-treatment and placebo-treatment groups, either in patients with initial stage I or stage II(-III) disease. However, after the 5-year follow-up, 18 steroid-treated patients (26%) and 30 placebo-treated patients (38%) still had remaining chest radiographic changes. Placebo-treated patients more frequently required treatment with corticosteroids during the 5-year follow-up (p < 0.05). Steroid-treated patients with initial stage II(-III) disease improved more in FVC and DLCO (p < 0.05). No differences in reported adverse events or in SACE, serum calcium, or urinary calcium values were seen.. Immediate treatment of pulmonary stage II(-III) sarcoidosis-but not stage I disease-improved the 5-year prognosis with regard to lung function variables.

Topics: Administration, Inhalation; Administration, Oral; Adult; Budesonide; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prednisolone; Respiratory Function Tests; Sarcoidosis, Pulmonary; Treatment Outcome

To evaluate the efficacy of oral prednisolone, followed by inhaled budesonide, in patients with newly diagnosed (<3 months) stage I and stage II pulmonary sarcoidosis.. Double-blind, placebo-controlled, parallel-group, multicenter study.. Twenty pulmonary medicine departments in Finland.. One hundred eighty-nine adult patients were randomized to treatment. Patients with erythema nodosum or stage IV sarcoidosis (pulmonary fibrosis), and patients requiring immediate treatment with oral corticosteroids for extrapulmonary lesions or chronic illnesses were excluded.. The patients received either oral prednisolone for 3 months (20 mg/d for 8 weeks, 15 mg/d for 2 weeks, and 10 mg/d for 2 weeks) followed by inhaled budesonide (Pulmicort Turbuhaler; Astra Draco; Lund, Sweden) for 15 months at 800 microg bid, or placebo tablets followed by placebo inhaler therapy.. Chest radiographs, lung volumes (FVC), diffusing capacity of the lung for carbon monoxide (D(LCO)), serum angiotensin-converting enzyme (SACE), and beta2-microglobulin at 3-month intervals.. After 3 months of treatment, radiographic improvements were seen in the active-treatment group when compared to the placebo-treatment group. At 6 months, the difference was still statistically significant. Later, no differences were found. In patients with initial stage I lesions, neither the FVC nor the D(LCO) (the percent predicted mean values) changed during the study, as they were normal from the beginning. In patients with initial stage II disease, the difference in the FVC mean values between the groups also remained unchanged throughout the study. In stage II patients treated for 18 months, but not earlier, the difference in D(LCO) became statistically significant; the largest differences were seen in patients with initial FVC values <80% of predicted and D(LCO) values <75% of predicted. The decrease in SACE in the active-treated stage II patients was significantly larger than in the placebo-treated patients. No difference was observed in adverse events between the active-treated patients and the placebo-treated patients.. Treatment is not required for patients with stage I disease. An initial treatment with prednisolone followed by long-term inhalation of budesonide is more effective than placebo in patients with stage II disease. Sequential oral and inhaled corticosteroid therapy may be an alternative treatment regimen for stage II sarcoidosis patients, rather than long-term oral corticosteroid therapy alone.

Topics: Administration, Inhalation; Administration, Oral; Adult; Anti-Inflammatory Agents; Budesonide; Double-Blind Method; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Prednisolone; Sarcoidosis, Pulmonary; Treatment Outcome

Topics: Administration, Inhalation; Aerosols; Bronchodilator Agents; Budesonide; Drug Administration Schedule; Female; Humans; Male; Pregnenediones; Sarcoidosis, Pulmonary; Time Factors

In a double-blind, placebo-controlled study, we assessed the efficacy of inhaled budesonide on the course of newly diagnosed pulmonary sarcoidosis and whether budesonide treatment could postpone oral corticosteroid treatment. We evaluated: 1) symptoms; 2) chest radiography; 3) angiotensin-converting enzyme (ACE) in serum; and 4) lung function. Patients with histologically confirmed pulmonary sarcoidosis with chest radiographic stages I, II or III, and with an abnormal lung function (inspiratory vital capacity (IVC) < 79% of predicted or transfer factor of the lungs for carbon monoxide (TL,CO) < 77% pred) were included. Patients with radiographic stage II or III but with normal lung function were included when more than 20% of the total cell population in bronchoalveolar lavage fluid (BALF) was lymphocytes. Forty seven patients received placebo or budesonide (1.2 mg) once daily via a Nebuhaler for 6 months, followed by 6 months without treatment. Based on predetermined criteria, 11 patients were excluded during the blind treatment period as they needed oral prednisone: seven (28%) patients in the placebo group (n = 25) and four (18%) patients in the budesonide group (n = 22). Patient's Global Clinical Impression (GCI) score showed a significant difference in favour of budesonide. IVC showed a significant difference of 7.9% predicted between the two groups during the active treatment period. This difference persisted during follow-up, when the difference was 9.4% pred. TL,CO remained nearly unchanged over time, with no difference between the groups. Improvements in chest radiographic appearance and changes in serum ACE were similar for the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Inhalation; Administration, Oral; Adult; Aerosols; Bronchoalveolar Lavage Fluid; Bronchodilator Agents; Budesonide; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Lung; Male; Peptidyl-Dipeptidase A; Prednisone; Pregnenediones; Radiography; Respiratory Function Tests; Sarcoidosis, Pulmonary; Time Factors; Treatment Outcome

Forty-seven patients with pulmonary sarcoidosis stage II-III, fulfilling clinical indications for starting treatment with corticosteroids, received oral methylprednisolone for 8 weeks in gradually decreasing doses (starting dose 48 mg per day). From week 5 onwards, they also received inhaled budesonide, 1.6 mg daily. Treatment was continued for 18 months and all patients have been followed for at least 3 years. At 18 months treatment could be discontinued in 38 patients, who had used individually adjusted doses of budesonide depending on the clinical response (reduced doses in 14, initial dose in 16, and increased doses in 8 patients). Budesonide treatment alone was satisfactory in 31 of these 38 cases. An additional seven patients could stop treatment after receiving supplementary courses of oral steroids for 3-12 months. Treatment is ongoing in 9 patients in which 6 have extrapulmonary manifestations requiring oral steroids. The chest radiograph became normal in 22 patients and improved in 14. Significant improvements were noted in FVC and DLco in relation to predicted normal values. Serum ACE, lysozyme and beta 2-microglobulin values decreased significantly. Transient cough was seen in 5 and hoarseness in 3 patients. No systemic side-effects were noted; one patient taking 2.4 mg budesonide daily had a plasma cortisol value below the normal range. Inhaled budesonide seems to offer an effective and safe alternative to oral steroids for long-term maintenance treatment of patients with pulmonary sarcoidosis.

Topics: Administration, Inhalation; Administration, Oral; Administration, Topical; Aerosols; Anti-Inflammatory Agents; Budesonide; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Pregnenediones; Sarcoidosis, Pulmonary; Time Factors

To evaluate whether inhaled steroids in high doses might be of therapeutic value in pulmonary sarcoidosis.. Randomized, double blind and placebo controlled parallel study.. The out-patient clinic of the Department of Pulmonary Medicine, Gentofte Hospital, Copenhagen, Denmark.. Twenty-one untreated patients (17 males, 4 females, median age 33 years, range 21-65) and eight patients treated with systemic prednisolone. All patients had biopsy proven pulmonary sarcoidosis radiological stage I-III.. Treatment with either inhaled budesonide 1.2 mg day-1-2.0 mg day-1 (n = 9) or placebo (n = 12) for 12 months.. Clinical (cough, chest pain, dyspnoea) and paraclinical variables (chest X-ray, gallium scintigraphy, pulmonary function tests, and biochemical markers of disease activity: blood leukocytes, lymphocytes, serum (S-) angiotensin converting enzyme (ACE), S-1,25-OH-cholecalciferol, plasma (P-) calcium, P-immunoglobulins) were recorded before treatment, every three months during treatment, and 6 months after treatment had been discontinued.. There were no significant differences between the recorded variables in the budesonide and placebo groups. In general, a regression of disease activity was observed in both groups. Two patients in the treatment group, treated with 2.0 mg budesonide/day, and two in the placebo group had progression in disease and were put on systemic steroids.. Inhaled budesonide in doses of 1.2-2.0 mg day-1 had no recognizable therapeutic effect on pulmonary sarcoidosis.

Topics: Administration, Inhalation; Administration, Topical; Adult; Aerosols; Analysis of Variance; Anti-Inflammatory Agents; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Radiography; Respiratory Function Tests; Sarcoidosis, Pulmonary; Treatment Failure

The aim of this investigation was to compare inhaled budesonide with oral prednisone in maintenance treatment of pulmonary sarcoidosis. A double-blind controlled study was performed in 40 patients with stage II or III pulmonary sarcoidosis. After initial systemic 6 weeks treatment with prednisone (40 reduced to 20 mg daily) patients were allocated either to the systematically (S) or topically (T) treated group. S patients continued with 10 mg prednisone daily, T patients were given inhaled budesonide 1.6 mg daily. The progress of treatment was assessed by serial radiography, spirometry, serum Angiotensin Converting Enzyme (ACE) activity and plasma cortisol levels. All patients completed the 12 months treatment. Using the numerical score to assess changes on the chest radiograms S patients improved by 1.7 +/- 0.66 points; T patients improved by 1.15 +/- 0.81 points. Spirometric changes were not statistically significant. Serum ACE fell from 107 +/- 51 U/L in the S group and 92 +/- 40 U/L in the T group to 46 +/- 11 U/L and 38 +/- 21 U/L respectively during the initial phase of treatment. In the maintenance phase ACE levels remained lower than the initial ones in both groups. Morning plasma cortisol levels studied in 10 patients (5 in each group) decreased significantly during the initial phase. Thereafter cortisol levels remained low in the S patients returning to the lower limit of normal values in the T patients. We conclude that inhaled budesonide may be a safe and effective alternative to oral steroids in the maintenance treatment of pulmonary sarcoidosis especially in the early stage of the disease.

Topics: Administration, Inhalation; Administration, Oral; Administration, Topical; Adult; Anti-Inflammatory Agents; Budesonide; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Middle Aged; Peptidyl-Dipeptidase A; Prednisone; Pregnenediones; Sarcoidosis, Pulmonary; Vital Capacity

Topics: Administration, Inhalation; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Prednisolone; Pregnenediones; Sarcoidosis, Pulmonary

We present a pulmonary sarcoidosis patient with specific elevation of serum Krebs von den lungen-6 (KL-6) levels, who was successfully treated with inhaled corticosteroids. Pulmonary sarcoidosis was initially identified as a chest radiograph abnormality during a routine medical examination, and subsequently confirmed by a high serum level of soluble interleukin 2 receptor. The patient was started on high-dose inhaled budesonide because of high serum levels of angiotensin-converting enzyme (ACE) and KL-6. Following treatment, radiographic findings improved, ACE levels normalized, and serum KL-6 levels markedly decreased. No recurrence was detected at 100 months with a budesonide dosage of 800 μg/day. This case demonstrates the efficacy of highdose inhaled corticosteroids for the initial treatment of pulmonary sarcoidosis.

Topics: Budesonide; Glucocorticoids; Humans; Mucin-1; Peptidyl-Dipeptidase A; Sarcoidosis, Pulmonary

Topics: Aerosols; Bronchodilator Agents; Budesonide; Glucocorticoids; Humans; Pregnenediones; Sarcoidosis, Pulmonary