Double-blind, randomized, placebo-controlled trial of effect of nedocromil sodium on clinical and inflammatory parameters of asthma in children allergic to dust mite.
BACKGROUND
The purpose of this study was to determine the clinical effect of nedocromil sodium and its relationship with serum levels of inflammatory mediators by monitoring lung function and noninvasive markers of airway inflammation, such as eosinophil blood counts; serum ECP, sIL-2R, IL-4 and sICAM; and total IgE. Anti-inflammatory medications cause a reduction in the markers of airway inflammation, decrease the intensity of airway hyperresponsiveness, and improve clinical symptoms of asthma. Among the available choices is nedocromil sodium, which is favored in the treatment of asthmatic children due to its very mild side-effects. It has been previously shown to improve the clinical parameters of asthma, but there are limited data on its effect on inflammatory mediators in the serum of asthmatic children.


METHODS
In this double-blind, randomized, placebo-controlled 8-week trial, 39 children, aged 9-16 years, with moderate atopic asthma were randomly allocated to receive either nedocromil sodium, two puffs twice daily, 0.002 g/puff, or placebo, two puffs twice daily. The primary end points were the clinical parameters of asthma measured by asthma symptom score, FEV1, and PC20H. Other end points included the serum levels of various inflammatory markers - ECP, sIL-2R, IL-4, sICAM, and IgE.


RESULTS
Clinical and inflammatory parameters improved with the use of nedocromil sodium, compared with placebo. Nedocromil significantly decreased serum levels of inflammatory markers, as shown in the following table. No correlation was found between any of the measured parameters.


CONCLUSIONS
Nedocromil sodium provided effective anti-inflammatory treatment for children with moderate atopic asthma.
Stelmach
I
I
M. Curie Hospital, Department of Pediatrics and Allergy, Zgierz, Poland.
Jerzynska
J
J
Brzozowska
A
A
Kuna
P
P
D000293:Adolescent; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D001798:Blood Proteins / Q000187:drug effects / Q000276:immunology; D001985:Bronchial Provocation Tests / Q000379:methods; D002648:Child; D002669:Child Welfare; D016001:Confidence Intervals; D004311:Double-Blind Method; D004391:Dust / Q000009:adverse effects; D047091:Eosinophil Granule Proteins; D004804:Eosinophils / Q000187:drug effects / Q000276:immunology; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D006967:Hypersensitivity / Q000097:blood / Q000188:drug therapy / Q000276:immunology; D007073:Immunoglobulin E / Q000097:blood / Q000187:drug effects / Q000276:immunology; D018799:Intercellular Adhesion Molecule-1 / Q000097:blood / Q000187:drug effects; D015847:Interleukin-4 / Q000097:blood; D007958:Leukocyte Count; D008925:Mites / Q000276:immunology*; D017835:Nedocromil / Q000627:therapeutic use; D011044:Poland; D011237:Predictive Value of Tests; D015375:Receptors, Interleukin-2 / Q000097:blood / Q000187:drug effects; D012260:Ribonucleases; D012882:Skin Tests / Q000379:methods
D000893:Anti-Inflammatory Agents; D015415:Biomarkers; D001798:Blood Proteins; D004391:Dust; D047091:Eosinophil Granule Proteins; D015375:Receptors, Interleukin-2; D017835:Nedocromil; D018799:Intercellular Adhesion Molecule-1; D015847:Interleukin-4; D007073:Immunoglobulin E; D012260:Ribonucleases