Dose-related efficacy and safety of formoterol (Oxis) Turbuhaler compared with salmeterol Diskhaler in children with asthma
Jazyk angličtina Země Anglie, Velká Británie Médium print
Typ dokumentu klinické zkoušky, srovnávací studie, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
14998380
DOI
10.1046/j.0905-6157.2003.00096.x
PII: 096
Knihovny.cz E-zdroje
- MeSH
- albuterol aplikace a dávkování analogy a deriváty MeSH
- aplikace inhalační MeSH
- bronchiální astma diagnóza farmakoterapie MeSH
- bronchodilatancia aplikace a dávkování MeSH
- dítě MeSH
- dvojitá slepá metoda MeSH
- ethanolaminy aplikace a dávkování MeSH
- formoterol fumarát MeSH
- klinické křížové studie MeSH
- lidé MeSH
- mladiství MeSH
- plicní ventilace MeSH
- salmeterol xinafoát MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- albuterol MeSH
- bronchodilatancia MeSH
- ethanolaminy MeSH
- formoterol fumarát MeSH
- salmeterol xinafoát MeSH
To compare the dose-related bronchodilator efficacy and tolerability of formoterol (Oxis) Turbuhaler with salmeterol Diskhaler and placebo in children with asthma. A single-dose, randomized, double-blind, incomplete crossover study of 68 children (7-17 years), with moderate-to-severe asthma, 82% receiving inhaled corticosteroids. Patients received four of six treatments [4.5, 9, 18, or 36 microg formoterol (6, 12, 24 or 48 microg metered doses), 50 microg salmeterol (metered dose) or placebo] at 12-h visits, separated by > or =3 days. Forced expiratory volume in 1 s (FEV1), pulse, blood pressure, electrocardiogram, adverse events and urine formoterol were assessed. The therapeutic ratio of formoterol vs. salmeterol was estimated from the efficacy and systemic effects results. All active treatments significantly improved FEV1 compared with placebo. Formoterol 9-36 microg provided dose-related increases over salmeterol in lung function: average 12-h FEV1 (increases of 4.9-8.7%, p < 0.001) and FEV1 at 12 h post-dose (7.0-12.2%, p < 0.001). The onset of effect of formoterol was also significantly faster than salmeterol for doses > or =9 microg. Salmeterol 50 microg was estimated to be equieffective to 3.3 microg formoterol for 12-h average FEV1 and the estimated equieffective dose for a variety of systemic effects was 7.8-13.5 microg formoterol. All treatments were well tolerated. Formoterol (Oxis) Turbuhaler 4.5-36 microg provided dose-related improvements in bronchodilator efficacy in children with asthma. Formoterol > or =9 microg provided superior bronchodilator efficacy over 12 h compared with salmeterol Diskhaler 50 microg with no increase in systemic effects.
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