A pilot study of zafirlukast as an anti-inflammatory agent in the treatment of adults with cystic fibrosis.
BACKGROUND
Persistent endobronchial inflammation is in part responsible for the attrition of lung function seen in cystic fibrosis. Leukotrienes act as pro-inflammatory mediators. The aim of this study was to assess the efficacy of the leukotriene receptor antagonist zafirlukast as a potential anti-inflammatory agent in the treatment of adult patients with cystic fibrosis.


METHODS
Clinically stable patients were enrolled in the study if they had no history or clinical evidence of asthma, bronchial hyper-reactivity, or aspergillosis. They were randomised to receive zafirlukast 20 mg twice daily with all routine treatment for four months or routine treatment alone in an open cross-over design. Primary endpoints were changes in respiratory function tests and a modified NIH clinical score.


RESULTS
Thirty patients were enrolled and 25 completed. There was a significant improvement in the modified NIH clinical score but no significant increase in respiratory function with zafirlukast.


CONCLUSIONS
Patients receiving a leukotriene receptor antagonist in addition to routine treatments showed significant improvement in a clinical score which is a composite of clinical wellbeing, chest radiograph appearance, and physical examination. Respiratory function showed a non-significant trend towards improvement with treatment. Zafirlukast may benefit patients with CF. An adequately powered study is justified on the basis of these results.
Regional Adult CF Unit, Seacroft Hospital, York Road, Leeds, UK.
S P
SP
Conway
C
C
Etherington
D G
DG
Peckham
A
A
Whitehead
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003550:Cystic Fibrosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007211:Indoles; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D008297:Male; D048448:Phenylcarbamates; D010865:Pilot Projects; D013449:Sulfonamides; D014105:Tosyl Compounds / Q000627:therapeutic use*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D007211:Indoles; D020024:Leukotriene Antagonists; D048448:Phenylcarbamates; D013449:Sulfonamides; D014105:Tosyl Compounds; C062735:zafirlukast