Evaluation of Rapid Onset of Action of ICS/LABA Combination Therapies on Respiratory Function in Asthma Patients: A Single-Center, Open-Label, Randomized, ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-09-07

AUTHORS

Hiroyuki Ohbayashi, Sahori Kudo, Mitsue Ariga

ABSTRACT

IntroductionProducts based on inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combinations may provide different clinical benefits. This study was conducted to compare the rapid effects of three such combination products: formoterol/fluticasone (FFC) aerosol (pMDI), formoterol/budesonide (FBC) dry powder inhaler (DPI), and vilanterol/fluticasone furoate (VFC) DPI.MethodsThe study design was a three-armed, randomized, crossover study. Patients included in the study had stable moderate asthma, defined as an Asthma Control Questionnaire (ACQ) score ≤ 0.75, and were undergoing step 2 or 3 asthma treatment as defined by JGL2015. Subjects were treated with fluticasone propionate inhaled via Diskus® during a 2-week washout period before randomization. At visit 2, subjects were randomly assigned in a 1:1:1 ratio to FFC, FBC, or VFC, and evaluated for changes in pulmonary function over time. At visits 3 and 4, the treatment was switched to another ICS/LABA combination in a crossover manner after a 1-week washout period. Spirometry was performed pre-dose and at 3, 10, and 30 min post-dose, and forced oscillation was implemented pre-dose and at 1, 7, 15, and 60 min post-dose.ResultsFifteen outpatients (63.3 ± 9.5 years, ACQ: 0.13 ± 0.19) completed the study. ∆FEV1 at 3 min did not significantly differ among the three groups. Significant increases in FEV1 and %FEV1 from baseline were observed in the FFC (p = 0.004, 0.003), FBC (p = 0.014, 0.011), and VFC (p = 0.032, 0.023) groups at 30 min. Improvements in respiratory resistance at 5–20 Hz from baseline at 60 min, resonant frequency, respiratory system reactance at 5 Hz, and low-frequency reactance area from baseline were observed at 1 min in the FFC group (p = 0.014, 0.002, 0.027, 0.018, respectively).ConclusionFFC administered using a pMDI showed favorable delivery to peripheral airways and significantly more rapid action promptly after inhalation as compared with other ICS/LABA preparations inhaled using a DPI, thus broadening the potential therapeutic options for asthma.Trial Registration NumberUMIN000029379.FundingKyorin Pharmaceutical Co., Ltd. More... »

PAGES

159-169

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s41030-018-0062-x

DOI

http://dx.doi.org/10.1007/s41030-018-0062-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1106856232

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32026393


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