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

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.

Historical cohort study examining comparative effectiveness of albuterol inhalers with and without integrated dose counter for patients with asthma or chronic obstructive pulmonary disease

“…Prior studies of patients with asthma or COPD have reported high levels of patient satisfaction (>90%) with the use of dose counters on MDIs containing rescue medication, specifically with regard to the ability to know when the inhaler should be replaced 1,2. In a recent online survey of 590 adults and children with asthma, many of whom were found to have empty or expired reliever inhalers, the addition of a dose counter was named most frequently as a means of improving satisfaction with their reliever inhalers 19.…”

“…Although dose counters can reliably monitor inhaler use,1–5 they are not currently integrated into some rescue MDIs, making it difficult for patients to know when those inhalers are empty. In one study, only 8% of patients reported counting the number of actuations and replacing their inhalers at or before the manufacturer’s specified maximum number of actuations had been reached 6.…”

Advances in Metered Dose Inhaler Technology: Hardware Development

“…With the addition of an integrated dose counter, 97.4% of patients reported that they could tell when to replace their inhalers (92). A complicating factor is the fact that MDIs require that a significant amount of excess formulation (often 20-30 doses worth) be filled into the canister during manufacturing.…”

New Inhaler Devices - The Good, the Bad and the Ugly

“…In a study assessing patients' satisfaction with current pMDIs, 52% of patients reported that they are extremely unsure and 10% are somewhat unsure of how much medication remains in their current rescue inhaler. With the addition of an integrated dose counter, 97% of patients reported that they could tell when to replace their inhalers [19]. This has been addressed by the incorporation of dose counters in the pMDI device.…”