Randomised controlled trial of inhaled corticosteroids (fluticasone propionate) in cystic fibrosis

Arch Dis Child. 1997 Aug;77(2):124-30. doi: 10.1136/adc.77.2.124.


Background: Controlling lung inflammation may be the key to improving morbidity and mortality in cystic fibrosis.

Objective: To assess the effects of inhaled corticosteroids on lung inflammation in cystic fibrosis.

Design: Double blind placebo controlled randomised sequence crossover trial. Fluticasone propionate (400 micrograms/day) was given as a dry powder inhaler for six weeks with a four week washout period before crossover.

Outcome measures: Sputum inflammatory markers (interleukin-8, tumour necrosis factor-alpha (TNF-alpha) and neutrophil elastase-both free and bound to alpha 1-antiprotease), sputum interleukin-10, lung function, and symptomatology.

Subjects: Twenty three children from a regional cystic fibrosis centre were enrolled into the study, with mean age 10.3 years (range 7 to 17 years) and mean baseline forced expiratory volume in one second (FEV1) of 64% (range 21% to 102%) predicted for sex and height. One patient was excluded for non-compliance to the study protocol.

Results: No significant benefit was shown for the use of fluticasone propionate in any of the outcomes. For sputum interleukin-8 there was an estimated true treatment median difference of 142 pg/ml (95% confidence interval (CI) 8 to 2866 pg/ml) in favour of placebo; while for maximal expiratory flow at 25% (MEF25%) remaining forced vital capacity predicted for sex and height there was a 15 percentage points (pp) (95% CI 4 to 26 pp) mean treatment difference in favour of placebo. Sputum interleukin-10 was undetected in any samples and unaffected by fluticasone propionate. Neither atopic status, baseline FEV1, nor concomitant DNase therapy had any effect on response to treatment.

Conclusions: Lack of benefit from fluticasone propionate was most likely due to failure of the drug to penetrate the viscid mucus lining the airways. It is suggested a large multicentre trial with higher doses given for a longer time by a different delivery system is required to assess efficacy.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Androstadienes / administration & dosage*
  • Androstadienes / therapeutic use
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / therapeutic use
  • Biomarkers / analysis*
  • Child
  • Cross-Over Studies
  • Cystic Fibrosis / drug therapy*
  • Cystic Fibrosis / immunology
  • Double-Blind Method
  • Female
  • Fluticasone
  • Humans
  • Inflammation
  • Interleukin-10 / metabolism
  • Interleukin-8 / metabolism
  • Leukocyte Elastase / metabolism
  • Lung / drug effects*
  • Male
  • Neutrophils / enzymology
  • Sputum / chemistry
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / metabolism


  • Androstadienes
  • Anti-Inflammatory Agents
  • Biomarkers
  • Interleukin-8
  • Tumor Necrosis Factor-alpha
  • Interleukin-10
  • Fluticasone
  • Leukocyte Elastase