We aimed to compare the efficacy and safety of budesonide/formoterol (Symbicort) with budesonide alone (Pulmicort) or budesonide (Pulmicort) and formoterol (Oxis) administered via separate inhalers in children with asthma. In a 12 wk, double-blind study, a total of 630 children with asthma (mean age 8 yr [4-11 yr]; mean forced expiratory volume in 1 s (FEV(1)) 92% predicted; mean inhaled corticosteroid dose 454 microg/day) were randomized to: budesonide/formoterol (80/4.5 microg, two inhalations twice daily); a corresponding dose of budesonide alone (100 microg, two inhalations twice daily); or a corresponding dose of budesonide (100 microg, two inhalations twice daily) and formoterol (4.5 microg, two inhalations twice daily) (budesonide + formoterol in separate inhalers). The primary efficacy variable was the change from baseline to treatment (average of the 12-wk treatment period) in morning peak expiratory flow (PEF). Other changes in lung function and asthma symptoms were assessed, as was safety. Budesonide/formoterol significantly improved morning PEF, evening PEF and FEV(1) compared with budesonide (all p < 0.001); there was no significant difference between budesonide/formoterol and budesonide + formoterol in separate inhalers for these variables. All other diary card variables improved from baseline in all treatment groups; there were no significant between-group differences. Adverse-event profiles were similar in all groups; there were no serious asthma-related adverse events in any treatment group. Conclusion: budesonide/formoterol significantly improved lung function in children (aged 4-11 yr) with asthma compared with budesonide alone. Budesonide/formoterol is a safe and effective treatment option for children with asthma.
- MeSH
- agonisté adrenergních beta-receptorů škodlivé účinky terapeutické užití MeSH
- bronchiální astma farmakoterapie metabolismus patofyziologie MeSH
- bronchodilatancia škodlivé účinky terapeutické užití MeSH
- dítě MeSH
- dvojitá slepá metoda MeSH
- ethanolaminy škodlivé účinky terapeutické užití MeSH
- financování organizované MeSH
- fixní kombinace léků MeSH
- hydrokortison krev moč MeSH
- kombinovaná farmakoterapie MeSH
- kvalita života MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- usilovný výdechový objem účinky léků MeSH
- vrcholová exspirační průtoková rychlost účinky léků MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- Publikační typ
- multicentrická studie MeSH
Acute effects of winter-type air pollution characterized by high levels of SO2, moderate levels of particles, and low acidity were studied. A panel of 155 asthmatic children and 102 adults with a history of asthma from the former German Democratic Republic cities of Erfurt and Welmar and from the Czech Republic city of Sokolov participated from September 1990 through June 1992. The panelists recorded daily symptoms, medication intake, and peak expiratory flow (PEF). Statistical analysis was based on linear regression of population-averaged time series controlling for trend, meteorology, and autocorrelation. A temporospatial time series approach was also applied to the data to eliminate possible confounding by some known or unknown variables that occurred simultaneously in two of the study areas. Weak same-day effects and a stronger cumulative effect of air pollution on children was observed both for PEF and for symptoms. PEF decreased -0.90% (-1.35 to -0.46%), and a symptom score increased 14.7% (0.8-28.6%) in association with an average increase of 128 micrograms/m3 SO2 over the previous 5 days. Effects on adults were smaller and less consistent. Morbidity of children was best predicted by SO2 and sulfate concentrations. The authors conclude that prolonged, high exposure to winter-type pollution was associated with small adverse health effects in asthmatics.
- MeSH
- aerosoly MeSH
- bronchiální astma chemicky indukované epidemiologie MeSH
- dítě MeSH
- dospělí MeSH
- látky znečišťující vzduch škodlivé účinky analýza MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- oxid siřičitý škodlivé účinky analýza MeSH
- počasí MeSH
- regresní analýza MeSH
- roční období MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- vrcholová exspirační průtoková rychlost účinky léků MeSH
- znečištění ovzduší škodlivé účinky MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Research Support, U.S. Gov't, P.H.S. MeSH
- Geografické názvy
- Česká republika MeSH
- Německo MeSH
- MeSH
- bronchiální astma * klasifikace patofyziologie MeSH
- bronchiální hyperreaktivita diagnóza farmakoterapie MeSH
- dítě MeSH
- domácí ošetřování MeSH
- dospělí MeSH
- lidé MeSH
- stupeň závažnosti nemoci MeSH
- vrcholová exspirační průtoková rychlost * účinky léků MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé MeSH