Beclometasone dipropionate (BDP) extrafine is a hydrofluoroalkane-based, chlorofluorocarbon (CFC)-free inhalation aerosol. This study was conducted to determine whether BDP extrafine and CFC-fluticasone proprionate (FP) aerosols were equivalent in terms of efficacy and tolerability in children with symptomatic mild-to-moderate asthma. Male and female patients (aged 5-12 yr) with an asthma diagnosis for > or =3 months, peak expiratory flow (PEF) > or =60% of predicted normal and suboptimal asthma control were randomised to double-blind treatment with BDP extrafine 200 microg day(-1) (n=139) or CFC-FP 200 microg day(-1) (n=141) for up to 18 weeks. After 6 and 12 weeks, study medication was 'stepped down' to 100 and 50 microg day(-1), respectively, if patients had achieved good asthma control. Patients with poor asthma control discontinued from the study and those with intermediate control continued in the study but did not undergo a dose reduction. The estimated treatment difference in morning PEF% predicted at 6 weeks was -1.9% (90% CI -4.9, 1.0). There was a trend towards a greater increase in forced vital capacity (% predicted) in the BDP extrafine group (5.3 versus 0.4%; p=0.084). A 'step-down' in therapy to 100 microg day(-1) was possible in 36% and 42% of patients in the BDP extrafine and CFC-FP groups, respectively, at 6 weeks. Both drugs were well tolerated. BDP extrafine and CFC-FP aerosols were equally effective at improving asthma control in children with mild-to-moderate asthma at the same daily dose.
We studied the effect of 2 months of treatment with budesonide (BUD) (Pulmicort), an inhaled corticosteroid, on the bronchial hyperresponsiveness to house-dust mite antigen (BHR-HDM) and to histamine (BHR-H). We also investigated whether BUD started 20 to 24 h after the development of a late asthmatic reaction (LAR) would influence the antigen-induced increase in nonspecific bronchial hyperresponsiveness to BHR-H. Thirty-one children with mild asthma who were atopic to HDM were randomized double blind into two parallel groups. Fifteen patients inhaled 0.2 mg BUD three times a day. Sixteen inhaled placebo in a similar way. Treatment began 20 to 24 h after antigen exposure and continued for 2 months. BHR-H and BHR-HDM were measured prior to and at the end of treatment. BHR-H was also determined 3 days after each antigen provocation. In the children receiving BUD, mean BHR-H and mean BHR-HDM were decreased approximately twofold after 2 months. No increase in BHR-H was observed after 3 days in the BUD group, irrespective of whether a LAR occurred. In patients in whom BUD treatment was withheld after the second antigen provocation, the protective effect of BHR-H was abolished. We conclude that 2 months of treatment with an inhaled corticosteroid causes a decrease in BHR-H and BHR-HDM. When an inhaled corticosteroid is administered 20 to 24 h after antigen provocation, It may protect against the antigen-induced increase in BHR-H. After treatment is discontinued, the protective effect wears off rapidly.
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