title: Beclomethasone dipropionate nasal aerosol with an integrated dose counter: functionality and performance.
abstract: Consistent medication delivery is critical for disease control including symptom management of allergic rhinitis (AR). Available aqueous intranasal corticosteroid devices lack an accurate dose (actuation) counter, which may lead patients to prematurely discard a unit or use a unit beyond its labeled number of actuations, therefore impacting patient adherence. Beclomethasone dipropionate (BDP) nasal aerosol, a nonaqueous hydrofluoroalkane formulation in a device with a novel integrated dose counter and an established efficacy/safety profile, was approved to treat AR-associated nasal symptoms in adolescent and adult patients. This study was designed to evaluate performance of the BDP nasal aerosol device with an integrated dose counter in perennial AR (PAR) patients. In a 6-week, double-blind, placebo-controlled study in PAR patients (≥12 years), patients were randomized to receive once-daily BDP nasal aerosol at 320 micrograms or placebo. In addition to assessing the primary efficacy end point, patients evaluated the performance of the device and reliability, accuracy, and functionality of the dose counter. Concordance between daily patient-reported actuations and dose counter readings was assessed by classifying discrepancies into four categories: "fire not count," "count not fire," "count unknown fire," and "count up unknown fire." Analysis was performed for the total device completer population (n = 374), which included all randomized patients completing ≥80% of actuations during the last 4 weeks of treatment. Low discrepancy rates were shown for all discrepancy categories. Of 41,891 patient-reported actuations, only 159 discrepancies (diary versus counter) were noted, resulting in an overall discrepancy rate of 0.38 per 100 actuations. The medically important discrepancy rate of "fire not count" was low (0.09 per 100 actuations). Overall, 79.1% of patients reported zero discrepancies, 9.4% reported one discrepancy, and 6.4% reported two discrepancies. These results showed the functionality and reliability of the BDP nasal aerosol device with an integrated dose counter in a clinical setting. (ClinicalTrials.gov identifier: NCT01134705.).
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California, USA.
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Phillip E
authors.initials: PE
authors.lastname: Korenblat
authors.forename: Bobby Q
authors.initials: BQ
authors.lastname: Lanier
authors.forename: Leith
authors.initials: L
authors.lastname: Kelley
authors.forename: Sudeesh K
authors.initials: SK
authors.lastname: Tantry
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D000369:Aged, 80 and over; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D019033:Delivery of Health Care, Integrated; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000336:Aerosols; D001507:Beclomethasone