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Open Access A 6-month safety and efficacy study of fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers in persistent asthma

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Background:

A novel multidose dry powder inhaler (MDPI) that is breath actuated, easy, and intuitive to use has been developed for administering fluticasone propionate (Fp) and Fp/salmeterol (FS).

Objective:

To assess the safety and efficacy of Fp MDPI versus Fp hydrofluoroalkane (HFA) and FS MDPI versus FS dry-powder inhaler (DPI).

Methods:

This phase III, 26-week, open-label, active drug‐controlled study enrolled subjects ≥12 years old with persistent asthma. Based on entry controller medication (inhaled corticosteroid [ICS] or ICS/long-acting beta-agonist), the subjects were randomized to twice-daily mid-strength Fp MDPI 100 μg or Fp HFA 220 μg, high-strength Fp MDPI 200 μg or Fp HFA 440 μg, mid-strength FS MDPI 100/12.5 μg or FS DPI 250/50 μg, or high-strength FS MDPI 200/12.5 μg or FS DPI 500/50 μg in a 3:1 MDPI to Fp HFA or FS DPI ratio. Safety and efficacy were assessed by adverse events (AE) and pulmonary function and asthma symptoms, respectively.

Results:

A total of 674 subjects were randomized. The AE incidence was similar across treatment groups (upper respiratory tract infections, sinusitis, and nasopharyngitis were most frequent). A higher percentage of subjects in the Fp HFA 440 μg and FS DPI 500/50 μg groups had oral candidiasis versus those who received Fp MDPI 200 μg or FS MDPI 200/12.5 μg, respectively. Serious AEs were similar between the treatments, with no unexpected findings. The incidence of asthma exacerbations was low and generally similar between the groups. Noninferiority was established for all Fp MDPI and FS MDPI doses compared with Fp HFA and FS DPI, respectively, for forced expiratory volume in 1 second. Changes in peak expiratory flow, rescue albuterol use, and symptoms were similar between treatments.

Conclusion:

The safety and efficacy profiles of Fp MDPI and FS MDPI administered at lower doses were generally comparable with those of Fp HFA and FS DPI, respectively, after 26 weeks of treatment.

The ClinicalTrials.gov identifier is NCT02175771.
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Keywords: Adolescent; adult; adverse drug events; asthma; corticosteroids; drug safety; dry powder inhaler; fluticasone propionate; inhalation devices; salmeterol

Document Type: Research Article

Publication date: 2017-07-01

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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