PMID- 12141723
OWN - NLM
STAT- MEDLINE
DCOM- 20020813
LR  - 20151119
IS  - 1081-1206 (Print)
IS  - 1081-1206 (Linking)
VI  - 89
IP  - 1
DP  - 2002 Jul
TI  - A randomized, double-blind trial of the effect of treatment with formoterol on 
      clinical and inflammatory parameters of asthma in children.
PG  - 67-73
AB  - 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.
FAU - Stelmach, Iwona
AU  - Stelmach I
AD  - Department of Pediatrics and Allergy, M Curie Hospital, Zgierz, Poland. 
      interna@wss.zgierz.pl
FAU - Gorski, Pawel
AU  - Gorski P
FAU - Jerzynska, Joanna
AU  - Jerzynska J
FAU - Stelmach, Wlodzimierz
AU  - Stelmach W
FAU - Majak, Pawel
AU  - Majak P
FAU - Kuna, Piotr
AU  - Kuna P
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 0 (Adrenergic beta-Agonists)
RN  - 0 (Blood Proteins)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Eosinophil Granule Proteins)
RN  - 0 (Ethanolamines)
RN  - 0 (Receptors, Interleukin-2)
RN  - 207137-56-2 (Interleukin-4)
RN  - EC 3.1.- (Ribonucleases)
RN  - W34SHF8J2K (Formoterol Fumarate)
SB  - IM
MH  - Adolescent
MH  - Adrenergic beta-Agonists/*therapeutic use
MH  - Asthma/*drug therapy
MH  - Blood Proteins/analysis
MH  - Bronchodilator Agents/*therapeutic use
MH  - Child
MH  - Double-Blind Method
MH  - Eosinophil Granule Proteins
MH  - Ethanolamines/*therapeutic use
MH  - Female
MH  - Formoterol Fumarate
MH  - Humans
MH  - Interleukin-4/blood
MH  - Male
MH  - Receptors, Interleukin-2/analysis
MH  - *Ribonucleases
EDAT- 2002/07/27 10:00
MHDA- 2002/08/14 10:01
CRDT- 2002/07/27 10:00
PHST- 2002/07/27 10:00 [pubmed]
PHST- 2002/08/14 10:01 [medline]
PHST- 2002/07/27 10:00 [entrez]
AID - S1081-1206(10)61913-8 [pii]
AID - 10.1016/S1081-1206(10)61913-8 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2002 Jul;89(1):67-73. doi: 
      10.1016/S1081-1206(10)61913-8.