Free Content Long-term safety and asthma control with budesonide/ formoterol versus budesonide pressurized metered-dose inhaler in asthma patients

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Safety concerns have been raised regarding the regular use of long-acting beta2-adrenergic agonists (LABAs) alone or with inhaled corticosteroids (ICSs). The purpose of this study was to examine the long-term safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI). This 52-week, double-blind study (SD-039-0728; n = 708) included patients ≥12 years of age with moderate to severe persistent asthma previously receiving ICSs. After 2 weeks on budesonide pMDI 320 g twice daily (b.i.d.), patients were randomized 3:1:1 overall to budesonide/formoterol pMDI 640/18 g b.i.d., budesonide/formoterol pMDI 320/9 g b.i.d., or budesonide pMDI 640 g b.i.d. The incidence of adverse events (AEs) was similar across the groups. Drug-related AEs (≥2% overall) were oral candidiasis, tremor, and pharyngolaryngeal pain. No clinically meaningful differences in laboratory, electrocardiogram, or Holter monitor variables were observed. The percentage of patients with ≥1 asthma exacerbation was significantly lower (p = 0.006) with budesonide/formoterol 640/18 (12.2%) and numerically lower with budesonide/formoterol 320/9 (14.4%) versus budesonide (21.8%). The number of asthma exacerbations per patient-treatment year was lower with budesonide/formoterol 640/18 (0.174; p = 0.004) and budesonide/formoterol 320/9 (0.185; p = 0.049) versus budesonide (0.315). Improvements in forced expiratory volume in 1 second and diary variables were significantly greater (p < 0.001) with both budesonide/formoterol doses versus budesonide. Budesonide/formoterol 640/18 and 320/9 g b.i.d. showed an acceptable safety profile relative to budesonide, with no significant or unexpected patterns of abnormalities observed by adding a LABA to budesonide for up to 1 year in this patient population. Improvements in asthma control were shown with both doses of budesonide/formoterol versus budesonide.

Keywords: Asthma; asthma control; budesonide; combination therapy; formoterol; inhaled corticosteroid; long-acting 2-adrenergic agonist; long-term safety; pressurized metered-dose inhaler; randomized controlled trial

Document Type: Research Article


Affiliations: 1: From the Section on Pulmonary and Critical Care Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, 2: Associate Clinical Professor, School of Medicine, Allergy/Immunology, University of California, San Diego School of Medicine, San Diego, California, and 3: AstraZeneca, Drug Development, Wilmington, Delaware

Publication date: September 1, 2008

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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