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Asthma control in pediatric patients treated with once-daily or twice-daily nebulized budesonide inhalation suspension (Pulmicort Respules)

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Abstract:

Composite end points may represent more meaningful assessments of asthma control compared with traditional discrete measures. The effects of budesonide inhalation suspension (BIS) on composite measures of asthma control have not been investigated. The purpose of this study was to assess changes from baseline in percentages of asthma control days (ACDs; days without asthma symptoms and rescue medication use; primary outcome), symptom-free days (SFDs), and rescue medication–free days (RFDs) with BIS treatment. We retrospectively analyzed separately data from three randomized, double-blind, placebo-controlled, 12-week studies (N = 1018) of BIS. Study I patients (4–8 years) were dependent on daily inhaled corticosteroids (ICS; n = 178). Study II patients (6 months to 8 years) were using one or more asthma medications (n = 481). Study III patients (6 months to 8 years) were using daily non-ICS asthma medication (n = 359). Patients treated with BIS showed substantial improvements from baseline in all composite variables (ACDs, 21–31% versus placebo [PBO], 10–18%; SFDs, 20–29% versus PBO, 11–18%; RFDs, 24–47% versus PBO, 12–28%). In study I, each BIS regimen statistically significantly improved all three asthma control measures versus PBO. In study II, BIS 0.5 mg twice daily (b.i.d.) improved ACDs, BIS 0.25 mg b.i.d. and 0.5 mg b.i.d. improved SFDs, and all BIS regimens improved RFDs statistically significantly. In study III, BIS 0.25 mg once daily (q.d.) improved all three measures, BIS 0.5 mg q.d. improved SFDs, and 1.0 mg q.d. improved RFDs statistically significantly. In conclusion, BIS improved composite measures of asthma control in children.

Keywords: Asthma; asthma control days; budesonide inhalation suspension; nebulizer; once-daily treatment; pediatrics; rescue medication–free days; retrospective study; symptom-free days; twice-daily treatment

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2008.29.3113

Affiliations: 1: Allergy Asthma Dermatology Research Center, Lake Oswego, Oregon 2: Allergy and Asthma Medical Group and Research Center, San Diego, California 3: AstraZeneca LP, Wilmington, Delaware

Publication date: May 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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