RESUMO
This 6-month, open-label extension study of a previously described base study compared oral montelukast with inhaled beclomethasone in terms of safety, forced expiratory volume in one second (FEV1) measurements, parent and patient satisfaction with treatment, asthma-related medical resource utilization, school absenteeism, and parental work loss in children with asthma. A total of 124 of 266 asthmatic children, 6 to 11 years of age, who enrolled in the base study entered a 6-month open-label extension study (74 boys, 50 girls) and were re-randomized (2:1 ratio) to receive once-daily oral montelukast (n = 83) or inhaled beclomethasone 100 mcg three times daily (n = 41). Children were evaluated in the clinic prior to re-randomization (Month 0) and at regular visits at 1, 3, and 6 months. Children and their parents showed a significantly higher overall satisfaction for montelukast at 6 months than for inhaled beclomethasone (p = 0.001 and p < 0.05, respectively). According to parents, montelukast was more convenient (p < 0.001), less difficult to use (p = 0.005), and was used as instructed more of the time (p = 0.006) compared with beclomethasone. Oral corticosteroid use was similar in the montelukast (13% of patients) and beclomethasone (17%) treatment groups. The montelukast treatment group was more adherent with their regimen than the inhaled beclomethasone treatment group; almost twice as many children on montelukast compared with inhaled beclomethasone were highly compliant (82% versus 45%). The two study groups were similar with respect to overall safety, change in FEV1, asthma-related medical resource utilization, school absenteeism, and parental work loss. Montelukast represents a safe and effective asthma treatment regimen to which children with asthma are more likely to adhere.
Assuntos
Acetatos/uso terapêutico , Antiasmáticos/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Asma/tratamento farmacológico , Beclometasona/uso terapêutico , Quinolinas/uso terapêutico , Acetatos/administração & dosagem , Acetatos/efeitos adversos , Administração por Inalação , Administração Oral , Adolescente , Antiasmáticos/administração & dosagem , Antiasmáticos/efeitos adversos , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/efeitos adversos , Asma/fisiopatologia , Beclometasona/administração & dosagem , Beclometasona/efeitos adversos , Criança , Estudos Cross-Over , Ciclopropanos , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Recursos em Saúde/estatística & dados numéricos , Humanos , Masculino , Cooperação do Paciente , Satisfação do Paciente , Quinolinas/administração & dosagem , Quinolinas/efeitos adversos , Sulfetos , Fatores de Tempo , Resultado do TratamentoRESUMO
Groups of children with wheezing during respiratory illness, children without wheezing during respiratory illness, and appropriately matched healthy children were tested for the presence and concentration of leukotriene C4 (LTC4) in nasopharyngeal secretions, employing the techniques of reverse-phase high-pressure liquid chromatography and radioimmunoassay. Although most wheezing children had LTC4 in nasopharyngeal secretions, the concentration of LTC4 among wheezing children who shed respiratory viruses was found to be consistently elevated (mean 1520 +/- 228 pg/0.1 mL) compared with values in wheezing children without evidence of viral infection (mean 709 +/- 147 pg/0.1 mL). In sharp contrast, little or no LTC4 activity was detected in healthy children (mean 106 +/- 77 pg/0.1 mL). These observations suggest that respiratory viruses are stimuli for the release of mediators of inflammation such as LTC4. Thus development of virus-induced bronchospasm may be related in part to direct mucosal cell-virus interaction and the release of pharmacologically active mediators in the respiratory tract.