No effect of high-dose inhaled steroids in pulmonary sarcoidosis: a double-blind, placebo-controlled study

J Intern Med. 1994 Sep;236(3):285-90. doi: 10.1111/j.1365-2796.1994.tb00798.x.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Administration, Topical
  • Adult
  • Aerosols
  • Analysis of Variance
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / therapeutic use*
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / therapeutic use*
  • Budesonide
  • Double-Blind Method
  • Female
  • Glucocorticoids
  • Humans
  • Male
  • Middle Aged
  • Pregnenediones / administration & dosage
  • Pregnenediones / therapeutic use*
  • Radiography
  • Respiratory Function Tests
  • Sarcoidosis, Pulmonary / diagnostic imaging
  • Sarcoidosis, Pulmonary / drug therapy*
  • Sarcoidosis, Pulmonary / physiopathology
  • Treatment Failure


  • Aerosols
  • Anti-Inflammatory Agents
  • Bronchodilator Agents
  • Glucocorticoids
  • Pregnenediones
  • Budesonide