Study design (if review, criteria of inclusion for studies)
open cross-over design.
Participants
30 clinically stable patients were enrolled in the study if they had no history or clinical evidence of asthma, bronchial hyper-reactivity, or aspergillosis. 25 patients completed the study.
Interventions
zafirlukast 20 mg twice daily with all routine treatment for four months or routine treatment
Outcome measures
Primary endpoints were changes in respiratory function tests and a modified NIH clinical score
Main results
There was a significant improvement in the modified NIH clinical score but no significant increase in respiratory function with zafirlukast.
Authors' 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.