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Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma

Background: Wixela(®) Inhub(®) is a dry powder inhaler approved as a generic equivalent to Advair(®) Diskus(®) (fluticasone propionate [FP]/salmeterol fixed-dose combination) for patients with asthma or chronic obstructive pulmonary disease (COPD). This study aimed at confirming the local (lung) the...

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Autores principales: Ng, Dik, Kerwin, Edward M., White, Martha V., Miller, S. David, Haughie, Scott, Ward, Jonathan K., Allan, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7133441/
https://www.ncbi.nlm.nih.gov/pubmed/31634023
http://dx.doi.org/10.1089/jamp.2019.1547
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author Ng, Dik
Kerwin, Edward M.
White, Martha V.
Miller, S. David
Haughie, Scott
Ward, Jonathan K.
Allan, Richard
author_facet Ng, Dik
Kerwin, Edward M.
White, Martha V.
Miller, S. David
Haughie, Scott
Ward, Jonathan K.
Allan, Richard
author_sort Ng, Dik
collection PubMed
description Background: Wixela(®) Inhub(®) is a dry powder inhaler approved as a generic equivalent to Advair(®) Diskus(®) (fluticasone propionate [FP]/salmeterol fixed-dose combination) for patients with asthma or chronic obstructive pulmonary disease (COPD). This study aimed at confirming the local (lung) therapeutic equivalence of both the FP and salmeterol components of Wixela Inhub (test [T]) to Advair Diskus (reference [R]) after inhalation. Methods: This randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in patients ≥18 years with mild-to-moderate persistent asthma compared the local therapeutic equivalence (using forced expiratory volume in 1 second [FEV(1)]) of FP/salmeterol (100/50 μg) after inhaled delivery via T and R. Results: Randomized patients (N = 1127) received T (n = 512), R (n = 512), or placebo (n = 103). T and R significantly increased day 1 FEV(1) area under the effect curve over 12 hours of the change from baseline (AUC([0–12])) and day 29 trough FEV(1) over placebo, indicating that these endpoints were sufficiently sensitive for evaluation of bioequivalence. On day 1, T and R each increased FEV(1) AUC((0–12)) over placebo (3.134 L•h [T], 2.677 L•h [R]; each p < 0.0001). Following twice-daily dosing for 28 days, T and R also each increased trough FEV(1) (measured on day 29) over placebo (235 mL [T], 215 mL [R]; each p < 0.0001). Least-squares mean T/R ratios (90% confidence intervals) for day 1 FEV(1) AUC((0–12)) and day 29 trough FEV(1) were 1.120 (1.016–1.237) and 1.069 (0.938–1.220), respectively, indicating that T and R were bioequivalent for both co-primary endpoints. FP/salmeterol was well tolerated when administered via either T or R. Conclusions: These results demonstrate that the therapeutic effects of Wixela Inhub are bioequivalent to Advair Diskus in the lung. Wixela Inhub represents a therapeutically equivalent new FP/salmeterol treatment option for use in the treatment of asthma and COPD.
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spelling pubmed-71334412020-04-06 Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma Ng, Dik Kerwin, Edward M. White, Martha V. Miller, S. David Haughie, Scott Ward, Jonathan K. Allan, Richard J Aerosol Med Pulm Drug Deliv Original Research Background: Wixela(®) Inhub(®) is a dry powder inhaler approved as a generic equivalent to Advair(®) Diskus(®) (fluticasone propionate [FP]/salmeterol fixed-dose combination) for patients with asthma or chronic obstructive pulmonary disease (COPD). This study aimed at confirming the local (lung) therapeutic equivalence of both the FP and salmeterol components of Wixela Inhub (test [T]) to Advair Diskus (reference [R]) after inhalation. Methods: This randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in patients ≥18 years with mild-to-moderate persistent asthma compared the local therapeutic equivalence (using forced expiratory volume in 1 second [FEV(1)]) of FP/salmeterol (100/50 μg) after inhaled delivery via T and R. Results: Randomized patients (N = 1127) received T (n = 512), R (n = 512), or placebo (n = 103). T and R significantly increased day 1 FEV(1) area under the effect curve over 12 hours of the change from baseline (AUC([0–12])) and day 29 trough FEV(1) over placebo, indicating that these endpoints were sufficiently sensitive for evaluation of bioequivalence. On day 1, T and R each increased FEV(1) AUC((0–12)) over placebo (3.134 L•h [T], 2.677 L•h [R]; each p < 0.0001). Following twice-daily dosing for 28 days, T and R also each increased trough FEV(1) (measured on day 29) over placebo (235 mL [T], 215 mL [R]; each p < 0.0001). Least-squares mean T/R ratios (90% confidence intervals) for day 1 FEV(1) AUC((0–12)) and day 29 trough FEV(1) were 1.120 (1.016–1.237) and 1.069 (0.938–1.220), respectively, indicating that T and R were bioequivalent for both co-primary endpoints. FP/salmeterol was well tolerated when administered via either T or R. Conclusions: These results demonstrate that the therapeutic effects of Wixela Inhub are bioequivalent to Advair Diskus in the lung. Wixela Inhub represents a therapeutically equivalent new FP/salmeterol treatment option for use in the treatment of asthma and COPD. Mary Ann Liebert, Inc., publishers 2020-04-01 2020-04-02 /pmc/articles/PMC7133441/ /pubmed/31634023 http://dx.doi.org/10.1089/jamp.2019.1547 Text en © Dik Ng, et al., 2020. Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Original Research
Ng, Dik
Kerwin, Edward M.
White, Martha V.
Miller, S. David
Haughie, Scott
Ward, Jonathan K.
Allan, Richard
Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma
title Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma
title_full Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma
title_fullStr Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma
title_full_unstemmed Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma
title_short Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma
title_sort clinical bioequivalence of wixela inhub and advair diskus in adults with asthma
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7133441/
https://www.ncbi.nlm.nih.gov/pubmed/31634023
http://dx.doi.org/10.1089/jamp.2019.1547
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