M. Ip et al., NEDOCROMIL SODIUM IN THE MANAGEMENT OF CHRONIC BRONCHIAL INFECTION, Journal of clinical pharmacy and therapeutics, 18(5), 1993, pp. 337-341
A double-blind parallel group comparative pilot study was carried out
in patients with bronchiectasis to evaluate the anti-inflammatory effe
ct of nedocromil sodium in chronic bronchial infection. Patients were
randomized to either a nedocromil sodium metered dose inhaler, 4 mg, f
our times daily, or placebo for 12 weeks. Clinical symptoms, lung func
tion tests and sputum characteristics of volume, purulence, leucocyte
count, neutrophil chemotactic activity and elastolytic activity were e
valuated at baseline, after 4, 8 and 12 weeks of the trial. Patients w
ere withdrawn when they had acute infective exacerbation. There were 1
3 evaluable patients and results were statistically analysed at 8 week
s due to the limited number of patients remaining in the study at 12 w
eeks. There was no significant change in any of the parameters in eith
er active or placebo group. Hence, nedocromil sodium has not been foun
d to contribute to the management of stable bronchiectasis in this stu
dy and larger studies are required to identify more modest effects.