A randomized, double-blind trial of the effect of treatment with formoterol on clinical and inflammatory parameters of asthma in children.

Abstract

BACKGROUND:

In addition to their bronchodilating effect, long-acting inhaled beta-agonists have recently been shown to have some anti-inflammatory properties.

OBJECTIVE:

The purpose of this study was to evaluate the effect of formoterol on inflammatory mediators in children.

METHODS:

In this double-blind, randomized, placebo-controlled trial, 34 children, aged 6 to 18 years, with moderate atopic asthma, were randomly allocated to receive formoterol or matching placebo for 4 weeks. The primary endpoint of this study was to determine changes in serum levels of inflammatory markers after treatment with formoterol; secondary endpoints included clinical efficacy and bronchial hyperreactivity. The following parameters were measured: symptom score, forced expiratory volume in 1 second (FEV1), provocative concentration of histamine causing a 20% fall in FEV1 (PC20) for histamine and peripheral blood eosinophil count, serum levels of eosinophil cationic protein (ECP), soluble receptor of interleukin-2 (sIL-2R), level of interleukin-4 (IL-4), level of soluble intercellular adhesion molecule-1 (ICAM-1), and immunoglobulin E (IgE) level before and after treatment.

RESULTS:

Compared with placebo, treatment with formoterol significantly improved lung function. The mean value of FEV1 changed from 74% of predicted value before treatment to 80% of predicted value after treatment (P < 0.001). The mean concentration of eosinophil blood count before and after treatment was 379 and 310 cells/mm3 (P = 0.035); ECP was 93 and 83 mcg/L; and serum IL-4 was 0.13 and 0.11 pg/mL (P = 0.001). There was no significant difference between formoterol and placebo recipients in PC20H, and serum concentration of sIL-2R, sICAM-1, or IgE after treatment. The group that received formoterol showed improvement in pulmonary function as measured by FEV1 (P < 0.001), and PC20H (P = 0.04) after 4 weeks of treatment. These patients also showed improvement of clinical symptoms (P < 0.001). Serum marker measurements in the formoterol group showed decreased concentrations of eosinophil blood count, ECP, and IL-4, but there was no difference in before and after measurements of sIL-2R, sICAM-1, and IgE.

CONCLUSIONS:

These results indicate that formoterol has measurable anti-inflammatory properties and can diminish asthma symptoms and bronchial hyperreactivity.

• Authors: Iwona Stelmach, Pawel Gorski, Joanna Jerzynska, Wlodzimierz Stelmach, Pawel Majak, Piotr Kuna
• Journal: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol) Vol. 89 Issue 1 Pg. 67-73 (Jul 2002) ISSN: 1081-1206 [Print] United States
• PMID: 12141723 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Adrenergic beta-Agonists
• Blood Proteins
• Bronchodilator Agents
• Eosinophil Granule Proteins
• Ethanolamines
• Receptors, Interleukin-2
• Interleukin-4
• Ribonucleases
• Formoterol Fumarate

Topics

• Adolescent
• Adrenergic beta-Agonists (therapeutic use)
• Asthma (drug therapy)
• Blood Proteins (analysis)
• Bronchodilator Agents (therapeutic use)
• Child
• Double-Blind Method
• Eosinophil Granule Proteins
• Ethanolamines (therapeutic use)
• Female
• Formoterol Fumarate
• Humans
• Interleukin-4 (blood)
• Male
• Receptors, Interleukin-2 (analysis)
• Ribonucleases