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Particle size and small airway effects of mometasone furoate delivered by dry powder inhaler

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Abstract:

Inhaled corticosteroids administered by dry powder inhaler (DPI) or metered-dose inhaler are potent anti-inflammatory agents recommended for management of persistent asthma. Respiratory pharmacotherapy is unique in that proper delivery of the medication can be as important as the medication that is delivered. This study was designed to assess the mass median aerodynamic diameter (MMAD) of mometasone furoate (MF) particles from the 100- and 200-microgram/inhalation strength Twisthhaler (Merck & Co., Inc., Whitehouse Station, NJ) and to examine clinical effects of MF-DPI on midexpiratory flow. The MMAD with 100- and 200-microgram Twisthaler inhalers was analyzed using an Anderson cascade impactor. Clinical trial data for MF-DPI administered q.d. in the evening (P.M.) in adults and adolescents aged ≥12 years, as well as children aged 4‐11 years, were examined post hoc for changes in forced expiratory flow between 25 and 75% of vital capacity (FEF25‐75). The average MMAD of the 100-microgram strength Twisthaler (n = 24) was 2.0 micrometers; the average MMAD of the 200-microgram strength Twisthaler (n = 24) was 2.2 micrometers. In adults and adolescents (n = 1149), significant improvements in FEF25‐75 occurred with MF-DPI administered q.d. P.M. versus placebo (p ≤ 0.05). In children (n = 296), FEF25‐75 improved significantly with MF-DPI at 100 microgram q.d. P.M. versus placebo at day 4 and every visit thereafter (p ≤ 0.05). In vitro study suggests that the particle size of MF is optimal (∼2 micrometers) for efficient lung deposition when administered via the Twisthaler. Furthermore, randomized, controlled trials provide clinical evidence that MF-DPI q.d. treatment improves small airway function in patients with mild persistent or moderate asthma.

Keywords: Asthma; DPI; FEF25‐75, forced expiratory flow; deposition; impactor; inhaled corticosteroid; mass median aerodynamic diameter; midexpiratory; spirometry

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2013.34.3648

Affiliations: Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, USA

Publication date: January 1, 2013

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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