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Prospective, open-label assessment of albuterol sulfate hydrofluoroalkane metered-dose inhaler with new integrated dose counter

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Abstract:

Metered-dose inhalers (MDIs) allow patients who require therapy for various respiratory diseases to deliver these therapies directly to the airways via inhalation. MDIs are designed to contain more propellant than required for administration of the labeled number of actuations; therefore, the amount of active medication/actuation remaining after administration of the labeled number of actuations may result in a lower than therapeutic dose of active medication. An MDI with an integrated dose counter provides the only reliable means by which a patient can track the amount of medication remaining in the MDI. This study evaluated the functionality, reliability, accuracy, and patient satisfaction with albuterol sulfate hydrofluoroalkane (HFA) MDI with a new integrated dose counter in the clinical setting. Patients aged ≥4 years with asthma, chronic obstructive pulmonary disease, or both, participated in this phase 4, prospective, open-label study. Treatment was twice-daily dosing with albuterol HFA MDI at 90 micrograms with dose counter for either 5 or 7 weeks. Concordance/agreement between daily patient recordings of actuations and counter readings was assessed with five discrepancy types: fire not count (undercount; primary end point), count not fire (overcount), fire count up within a dose (counter reading increased, instead of decreased, after MDI was actuated), count unknown fire (counter number at the beginning of a dosing session was less than counter number at the end of the previous session), and count up unknown fire (counter number at the beginning of a dosing session was greater than counter number at the end of the previous session). Responses to twelve questions designed to evaluate confidence, ease of use, and patient satisfaction were also analyzed. Overall discrepancy rate was 1.87 per 200 actuations. Primary end point (fire not count rate) was 0.30 per 200 actuations. Overall, ∼95‐97% of patients were “very satisfied” or “somewhat satisfied” with the albuterol HFA MDI with dose counter, its ease of use, and the ability to tell when it should be replaced. The albuterol HFA MDI with new integrated dose counter functioned reliably and accurately in the clinical setting. Overall patient satisfaction was high with the albuterol HFA MDI with new integrated dose counter and the device was shown to function reliably and accurately. Clinicaltrials.gov identifier: NCT01302587.

Keywords: Adherence; albuterol; asthma; bronchodilator; chronic obstructive pulmonary disease; dose counter; inhalation therapy; metered-dose inhaler; patient satisfaction

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2012.33.3647

Affiliations: Allergy and Respiratory Center, Canton, Ohio, 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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