He has conducted multicenter clinical research trials for ∼40 pharmaceutical companies.M.V.W. reports grants from Mylan, during the conduct of the study; personal fees from Mylan; grants from Sanofi-Aventis; and grants from Genentech, outside the submitted work.This study was funded by Mylan, Inc. (Canonsburg, PA) who also provided funding for medical writing and editorial support.© Dik Ng, et al., 2020. Two steps forward, one step backKuna P, Thyroff-Friesinger U, Gath I, and Jones SRandomized equivalence trial: A novel multidose dry powder inhaler and originator device in adult and adolescent asthmaMylan. The placebo for Wixela Inhub used Inhub inhalers containing lactose alone.Spirometry assessments were completed at screening (day −28); at run-in (day −3 to −7); at −0.5, 0, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours on day 1 of treatment, before dosing on day 15, and on day 29. If you notice that you take more than one medicine in the same class, ask your physician to review your prescriptions. Note that sometimes, in severe COPD, patients may use this inhaler in addition to Advair or Symbicort To make sure your inhalers are OK to take together, look at the class of medications. Inhaled corticosteroids (ICS) and long-acting β2-adrenergic agonists (LABA) are widely used, safe, and effective anti-inflammatory and bronchodilator agents, respectively, for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Wixela ® Inhub ®. The steps for using Wixela Inhub are similar to those for ADVAIR DISKUS: Dosing Strengths: O nly th e 250/50 mcg str gth is indicated for COPD Wixela Inhub is a new, generic dry powder inhaler that is available in the same 3 dosage has participated in consulting, advisory boards, speaker panels, or received travel reimbursement for Amphastar, Astra Zeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan, Novartis, Oriel, Pearl, Sunovion, Teva, and Theravance. This study, recommended by the FDA for the clinical development of generic inhaled drugs containing FP and salmeterol powder,A direct comparison of these results with those reported for the original Advair Diskus pivotal trials can be challenging, not only due to the expected limitations inherent in comparing between studiesThe day 1 and day 29 spirometry data were also comparable with those reported for the OT329 SOLIS bioequivalence study, which used an almost identical study design.The design of this study was consistent with other FPS local therapeutic equivalence studies,Due to the difference in physical appearance of T and R, each treatment was administered twice daily for 28 days in a double-blind manner, using the double-dummy techniqueThe results of the primary analyses were corroborated by secondary analyses (assay sensitivity [PPS] and bioequivalence [FAS]) that showed that (The demonstration of local therapeutic equivalence using spirometry endpoints in this article is also supported by previously presented data on pharmacokinetic bioequivalence to all three-dose strengths of Advair Diskus (100/50, 250/50, and 500/50 μg FP/S) (Haughie et al., 2019), In conclusion, Wixela Inhub, which was recently approved by the FDA, will represent a new generic-equivalent FPS treatment option for asthmatic patients whose symptoms are uncontrolled with ICS alone and COPD patients at high risk of exacerbations.The authors acknowledge the study investigators and Bruce Williams (Mylan Pharma UK Ltd.) for clinical operations support. To evaluate assay sensitivity, comparisons of T versus placebo and R versus placebo were performed for day 1 FEVTo assess bioequivalence, LS means (one for T and one for R) from the ANCOVA models were used to generate T/R ratios for LS means for FEVOf the 1871 enrolled patients, 1127 (60%) were randomized and treated, with 512 patients each receiving T and R and 103 patients receiving placebo (Baseline demographic and clinical characteristics were well matched across treatment groups (Both active treatments substantially improved day 1 FEVBoth active treatments also substantially improved day 29 trough FEVBioequivalence was then assessed, and the T/R ratios for LS means (90% CIs) for day 1 FEVTreatment-emergent AEs occurred in 14.4% of patients in the safety set, with individual AEs displaying a similar incidence across the three treatment groups (Reported in ≥1% patients in the overall study population and/or ≥1% of any treatment group.AE, adverse event; R, reference product (Advair Diskus); T, test product (Wixela Inhub).Wixela Inhub was recently approved by the FDA as a fixed-dose FPS powder for oral inhalation to provide a generic equivalent to Advair Diskus. All rights reserved, USA and worldwide.The role of fluticasone propionate/salmeterol combination therapy in preventing exacerbations of COPDSalmeterol/fluticasone propionate: A review of its use in asthmaGINA: GINA report , Global Strategy for Asthma Management and PreventionDose-ranging study to evaluate the efficacy and safety of four doses of fluticasone propionate/salmeterol multidose dry powder inhaler (FS MDPI) compared with fluticasone propionate (FP) MDPI and FS DPI in subjects with persistent asthmaClinical bioequivalence of OT329 SOLIS and ADVAIR DISKUS in adults with asthmaGeneric competition for orally inhaled respiratory medications. In the same class, ask your physician to review your prescriptions can expect wixela Inhub was designed with in. If you notice that you take more than one medicine in the same class, your. Administration of fixed-dose ICS/LABA combination drugs as maintenance therapy in asthma and COPD Current guidelines recommend the of. 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