N Milman1, N Graudal, G Grode, E Munch. 1. Department of Pulmonary Medicine, Gentofte Hospital, University of Copenhagen, Denmark.
Abstract
OBJECTIVE: To evaluate whether inhaled steroids in high doses might be of therapeutic value in pulmonary sarcoidosis. DESIGN: Randomized, double blind and placebo controlled parallel study. SETTING: The out-patient clinic of the Department of Pulmonary Medicine, Gentofte Hospital, Copenhagen, Denmark. SUBJECTS:Twenty-one untreated patients (17 males, 4 females, median age 33 years, range 21-65) and eight patients treated withsystemic prednisolone. All patients had biopsy proven pulmonary sarcoidosis radiological stage I-III. INTERVENTIONS: Treatment with either inhaled budesonide 1.2 mg day-1-2.0 mg day-1 (n = 9) or placebo (n = 12) for 12 months. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSION:Inhaled budesonide in doses of 1.2-2.0 mg day-1 had no recognizable therapeutic effect on pulmonary sarcoidosis.
RCT Entities:
OBJECTIVE: To evaluate whether inhaled steroids in high doses might be of therapeutic value in pulmonary sarcoidosis. DESIGN: Randomized, double blind and placebo controlled parallel study. SETTING: The out-patient clinic of the Department of Pulmonary Medicine, Gentofte Hospital, Copenhagen, Denmark. SUBJECTS: 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. INTERVENTIONS: Treatment with either inhaled budesonide 1.2 mg day-1-2.0 mg day-1 (n = 9) or placebo (n = 12) for 12 months. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSION: Inhaled budesonide in doses of 1.2-2.0 mg day-1 had no recognizable therapeutic effect on pulmonary sarcoidosis.
Authors: Margaret M Mroz; John H Ferguson; Anna V Faino; Annyce Mayer; Matthew Strand; Lisa A Maier Journal: Respir Med Date: 2018-02-05 Impact factor: 3.415
Authors: Muhunthan Thillai; William Chang; Nazia Chaudhuri; Ian Forrest; Ling-Pei Ho; Sarah Lines; Toby M Maher; Lisa G Spencer; Monica Spiteri; Robina Coker Journal: BMJ Open Respir Res Date: 2019-02-18