Budesonide/formoterol improves lung function compared with budesonide alone in children with asthma

Authors: Pohunek, Petr¹; Kuna, Piotr²; Jorup, Carin³; De Boeck, Kris⁴

Source: Pediatric Allergy and Immunology, Volume 17, Number 6, September 2006 , pp. 458-465(8)

Buy & download fulltext article:

Price: $48.00 plus tax (Refund Policy)

Abstract:

Pohunek P, Kuna P, Jorup C, Boeck, KD. Budesonide/formoterol improves lung function compared with budesonide alone in children with asthma.

Pediatr Allergy Immunol 2006: 17: 458-465.

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 (FEV₁) 92% predicted; mean inhaled corticosteroid dose 454 μg/day) were randomized to: budesonide/formoterol (80/4.5 μg, two inhalations twice daily); a corresponding dose of budesonide alone (100 μg, two inhalations twice daily); or a corresponding dose of budesonide (100 μg, two inhalations twice daily) and formoterol (4.5 μg, 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 FEV₁ 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.

Keywords: asthma; budesonide; budesonide/formoterol; Pulmicort; Symbicort

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1399-3038.2006.00425.x

Affiliations: 1: University Hospital Motol, Prague, Czech Republic 2: Barlicki University Hospital, Medical University, Lodz, Poland 3: AstraZeneca R&D Lund, Lund, Sweden 4: University Hospital of Leuven, Leuven, Belgium

Publication date: 2006-09-01

Budesonide/formoterol improves lung function compared with budesonide alone in children with asthma

Buy & download fulltext article:

Tools

Key

Text size:

Useful pages