Introduction: Training in correct inhaler use, ideally in person or by video demonstration, can minimize errors but is rarely provided in clinics. This open-label, low-intervention study evaluated critical error rates with dry-powder inhalers (DPIs), before and after training, in patients with chronic obstructive pulmonary disease. Methods: Patients prescribed an inhaled corticosteroid (ICS)/long-acting β 2-agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/ LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler) were enrolled. Critical errors were assessed before training (Visit 1 [V1]; primary endpoint) and 6 weeks thereafter (Visit 2 [V2]; secondary endpoint). Logistic regression models were used to calculate odds ratios (ORs) for between-group comparisons. Results: The intent-to-treat population comprised 450 patients. At V1, fewer patients made ≥1 critical error with ELLIPTA (10%) versus other ICS/LABA DPIs (Turbuhaler: 40%, OR 4.66, P=0.005; DISKUS: 26%, OR 2.48, P=0.114) and other LAMA or LAMA/LABA DPIs (HandiHaler: 34%, OR 3.50, P=0.026; Breezhaler: 33%, OR 3.94, P=0.012). Critical error rates with the primary ICS/LABA DPI were not significantly different between ELLIPTA ICS/LABA (10%) and ICS/LABA plus LAMA groups (12-25%). Critical errors with the primary ICS/LABA DPI occurred less frequently with ELLIPTA ICS/LABA with or without LAMA (11%) versus Turbuhaler ICS/LABA with or without LAMA (39%, OR 3.99, P<0.001) and DISKUS ICS/LABA with or without LAMA (26%, OR 2.18, P=0.069). Simulating singleinhaler versus multiple-inhaler triple therapy, critical error rates were lower with ELLIPTA fluticasone furoate/vilanterol (FF/VI; 10%) versus ELLIPTA FF/VI plus LAMA (22%), considering errors with either DPI (OR 2.50, P=0.108). At V2, critical error rates decreased for all DPIs/groups, reaching zero only for ELLIPTA. Between-group comparisons were similar to V1. Conclusion: Fewer patients made critical errors with ELLIPTA versus other ICS/LABA, and LAMA or LAMA/LABA DPIs. The effect of "verbal" training highlights its importance for reducing critical errors with common DPIs.
Patients with multiple allergic/immunologic diseases may require simultaneous biologic therapies. However, there is a paucity of literature regarding patient safety and outcomes while receiving dual biologic therapies. METHODS: A search of the electronic medical record was performed to identify patients over 18 years old treated with a biologic from our allergy, asthma, and immunology specialty clinics at 2 large urban hospitals, and a second biologic for any other indication within the last 10 years. The first biologic was required to be one commonly used in allergy and immunology practices (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab, canakinumab). Dual therapy was subcategorized into either a period of overlap (at least one dose of each biologic within 30 days), or ongoing therapy (simultaneous treatment with both biologics beyond 30 days). RESULTS: A total of 314 patients in our clinics have been treated with a biologic, 26 (8.3%) of whom received dual biologic therapy. Twelve patients received ongoing simultaneous biologic therapy while 14 had a period of overlap with a second biologic. Eleven of 12 patients receiving ongoing therapy had a positive clinical response to the ''allergy"-based biologic. Dual biologic therapy was not associated with serum sicknesslike reactions, infusion related or injection site reactions, or any other significant adverse reaction. There was no evidence of increased immune suppression or frequency of infections reported by patients. CONCLUSIONS: This report of patients on dual biologic therapy adds to the literature suggesting that dual biologics may not increase risk or impair clinical response.
Rationale Asthma studies show many children use inhalers incorrectly even after instruction. For two age groups of children with asthma, we determined the proportions who used the once‐daily ELLIPTA dry‐powder inhaler (DPI) correctly, and who found it easy to use. Methods This was a multicenter, single‐arm, stratified, open‐label, placebo study (NCT03478657). Children aged 5–7 and 8–11 years were trained in, and required to demonstrate, correct placebo ELLIPTA DPI use at their first clinic visit. The inhaler was used at home once daily for 28 ± 2 days. On returning to the clinic, children were randomized to an age‐appropriate, ease‐of‐use questionnaire that had been developed and validated previously, and which rated the inhaler as “easy” or “hard” to use. Following questionnaire completion, children were then asked to demonstrate correct inhaler use. Correct use and ease‐of use were assessed in each age group (co‐primary endpoints) and overall (secondary endpoints). Results Of 222 enrolled children, 221 completed the study. Among children aged 5–7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared with 93% (n = 124/133) aged 8–11 years. Of these children, 98% (5–7 years: n = 79/81; 8–11 years: n = 121/124) rated the inhaler easy to use. Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use. Conclusion ELLIPTA DPI was used correctly and easily by most children on their first attempt without additional training.
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