Once- vs Twice-Daily Budesonide/Formoterol in 6- to 15-Year-Old Patients With Stable Asthma.
Summary of "Once- vs Twice-Daily Budesonide/Formoterol in 6- to 15-Year-Old Patients With Stable Asthma."
Objective: To assess efficacy/tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide pMDI (primary) and twice-daily budesonide/formoterol (secondary) in children/adolescents with asthma stabilized with twice-daily budesonide/formoterol. Methods: This 12-week multicenter, double-blind randomized controlled study (www.clinicaltrials.gov identifier NCT00646321) included 521 patients aged 6 to 15 years with mild/moderate persistent asthma. Patients stabilized during a 4- to 5-week run-in with twice-daily budesonide/formoterol pMDI 40/4.5 mug x 2 inhalations (160/18 mug daily) received twice-daily budesonide/formoterol pMDI 40/4.5 mug x 2 inhalations (160/18 mug daily), once-daily budesonide/formoterol pMDI 80/4.5 mug x 2 inhalations (160/9 mug daily; evening), or once-daily budesonide pMDI 80 mug x 2 inhalations (160 mug daily; evening). Results: Once- or twice-daily budesonide/formoterol was more effective than budesonide for evening peak expiratory flow (primary variable) at the end of the 24-hour once-daily dosing interval (P = .027). Twice-daily budesonide/formoterol demonstrated better efficacy versus once-daily treatments for evening predose forced expiratory volume in 1 second (P = .011), versus budesonide for daytime/nighttime rescue medication (P = .023), and versus once-daily budesonide/formoterol for daytime rescue medication (last 12 hours of once-daily dosing) (P = .032). There were no significant between-group differences for daytime/nighttime asthma symptoms, nighttime awakenings attributed to asthma, or health-related quality of life. Fewer patients experienced asthma worsening (predefined criteria) with twice-daily budesonide/formoterol (8.2%) versus once-daily budesonide (15.5%) (P = .036) or once-daily budesonide/formoterol (19.6%) (P = .002). All treatments were well tolerated. Conclusions: Once-daily budesonide/formoterol demonstrated significantly better efficacy than once-daily budesonide for most pulmonary-function variables. Twice-daily budesonide/formoterol (160/18 mug daily) maintenance therapy was generally more effective than stepping down to once-daily dosing (160/9 mug daily). Treatments were well tolerated, and there was no evident safety benefit for once- versus twice-daily dosing.
aPediatric Pulmonary Medicine, Childhood Asthma Care and Education Center, and Cystic Fibrosis Center, Louisville, Kentucky;
This article was published in the following journal.
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20713475
- DOI: http://dx.doi.org/10.1542/peds.2009-2970
Medical and Biotech [MESH] Definitions
The proportion of patients with a particular disease during a given year per given unit of population.
A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.
Seasonal Affective Disorder
A syndrome characterized by depressions that recur annually at the same time each year, usually during the winter months. Other symptoms include anxiety, irritability, decreased energy, increased appetite (carbohydrate cravings), increased duration of sleep, and weight gain. SAD (seasonal affective disorder) can be treated by daily exposure to bright artificial lights (PHOTOTHERAPY), during the season of recurrence.
A neuropsychological disorder related to alterations in DOPAMINE metabolism and neurotransmission involving frontal-subcortical neuronal circuits. Both multiple motor and one or more vocal tics need to be present with TICS occurring many times a day, nearly daily, over a period of more than one year. The onset is before age 18 and the disturbance is not due to direct physiological effects of a substance or a general medical condition. The disturbance causes marked distress or significant impairment in social, occupational, or other important areas of functioning. (From DSM-IV, 1994; Neurol Clin 1997 May;15(2):357-79)
El Nino-southern Oscillation
El Nino-Southern Oscillation or ENSO is a cycle of extreme alternating warm El Niño and cold La Nina events which is the dominant year-to-year climate pattern on Earth. Both terms refer to large-scale changes in sea-surface temperature across the eastern tropical Pacific. ENSO is associated with a heightened risk of certain vector-borne diseases. (From http://www.elnino.noaa.gov/lanina_new_faq.html, accessed 5/12/2020)
BACKGROUND: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD. METHODS: This double-blind, multicentre, three-period crossover study randomised 111 patient...
Aim:To evaluate the effect of inhaled formoterol-budesonide on airway remodeling in adult patients with moderate asthma.Methods:Thirty asthmatic patients and thirty control subjects were enrolled. Ast...
BACKGROUND AND OBJECTIVE: Inhaled glucocorticoids and long acting β2 -agonists reduce airway inflammation. It is unclear if this effect is based on the local action of the drugs or is due to a system...
ABSTRACT: BACKGROUND: There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler...
Background: In cases using a budesonide/formoterol combination inhaler, many patients are started on fixed-dose treatment at 640/18μg(4 puffs) daily, but there are no guidelines yet regarding the ste...
The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of b...
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP pro...
A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to non-smoking asthmatic patients. However, the comparative response to other currently prescribe...
The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults