Comparison of mometasone furoate dry powder inhaler and fluticasone propionate dry powder inhaler in patients with moderate to severe persistent asthma requiring high-dose inhaled corticosteroid therapy

Findings from a noninferiority trial

Ulf Harnest, David Price, Tim Howes, Gordon Sussman

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background. Inhaled corticosteroids (ICSs) are one of the suggested first-line therapies for patients with persistent asthma of moderate severity. Methods: The efficacy and safety of mometasone furoate (MF) 400 mu g twice daily (BID) and fluticasone propionate (FP) 500 mu g BID administered for 12 weeks via dry powder inhaler (DPI) were compared in a noninferiority trial, in adults with moderate-to-severe persistent asthma. The primary variable was the change from baseline in AM peak expiratory flow rate (PEFR). Pm PEFR, forced expiratory volume in 1 second (FEV1), asthma symptoms, rescue medication use, response to therapy, exacerbation rates, and adverse events were also assessed. Results. The lower bound of 95% CIs for treatment differences in the primary variable ranged from 2.6% to 5.6% throughout the 12-week study and were within the prespecified noninferiority range. No significant between-group differences were observed in lung function, rescue medication use, response to therapy, exacerbation rates, or adverse events. At most of the weeks assessed, there were no between-group differences in asthma symptoms. Most adverse events were mild-to-moderate. Conclusion. MF-DPI 400 mu g BID was therapeutically equivalent to FP-DPI 500 mu g BID in patients with moderate-to-severe persistent asthma.

Original languageEnglish
Pages (from-to)215-220
Number of pages6
JournalJournal of Asthma
Volume45
Issue number3
DOIs
Publication statusPublished - 2008

Keywords

  • asthma
  • fluticasone propionate
  • mometasone furoate
  • noninferiority trial
  • beta(2)-agonist
  • pituitary-adrenal axis
  • efficacy
  • safety
  • suppression

Cite this

@article{13a2054783744fe1a6cf2c9b65f71df2,
title = "Comparison of mometasone furoate dry powder inhaler and fluticasone propionate dry powder inhaler in patients with moderate to severe persistent asthma requiring high-dose inhaled corticosteroid therapy: Findings from a noninferiority trial",
abstract = "Background. Inhaled corticosteroids (ICSs) are one of the suggested first-line therapies for patients with persistent asthma of moderate severity. Methods: The efficacy and safety of mometasone furoate (MF) 400 mu g twice daily (BID) and fluticasone propionate (FP) 500 mu g BID administered for 12 weeks via dry powder inhaler (DPI) were compared in a noninferiority trial, in adults with moderate-to-severe persistent asthma. The primary variable was the change from baseline in AM peak expiratory flow rate (PEFR). Pm PEFR, forced expiratory volume in 1 second (FEV1), asthma symptoms, rescue medication use, response to therapy, exacerbation rates, and adverse events were also assessed. Results. The lower bound of 95{\%} CIs for treatment differences in the primary variable ranged from 2.6{\%} to 5.6{\%} throughout the 12-week study and were within the prespecified noninferiority range. No significant between-group differences were observed in lung function, rescue medication use, response to therapy, exacerbation rates, or adverse events. At most of the weeks assessed, there were no between-group differences in asthma symptoms. Most adverse events were mild-to-moderate. Conclusion. MF-DPI 400 mu g BID was therapeutically equivalent to FP-DPI 500 mu g BID in patients with moderate-to-severe persistent asthma.",
keywords = "asthma, fluticasone propionate, mometasone furoate, noninferiority trial, beta(2)-agonist, pituitary-adrenal axis, efficacy, safety, suppression",
author = "Ulf Harnest and David Price and Tim Howes and Gordon Sussman",
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TY - JOUR

T1 - Comparison of mometasone furoate dry powder inhaler and fluticasone propionate dry powder inhaler in patients with moderate to severe persistent asthma requiring high-dose inhaled corticosteroid therapy

T2 - Findings from a noninferiority trial

AU - Harnest, Ulf

AU - Price, David

AU - Howes, Tim

AU - Sussman, Gordon

PY - 2008

Y1 - 2008

N2 - Background. Inhaled corticosteroids (ICSs) are one of the suggested first-line therapies for patients with persistent asthma of moderate severity. Methods: The efficacy and safety of mometasone furoate (MF) 400 mu g twice daily (BID) and fluticasone propionate (FP) 500 mu g BID administered for 12 weeks via dry powder inhaler (DPI) were compared in a noninferiority trial, in adults with moderate-to-severe persistent asthma. The primary variable was the change from baseline in AM peak expiratory flow rate (PEFR). Pm PEFR, forced expiratory volume in 1 second (FEV1), asthma symptoms, rescue medication use, response to therapy, exacerbation rates, and adverse events were also assessed. Results. The lower bound of 95% CIs for treatment differences in the primary variable ranged from 2.6% to 5.6% throughout the 12-week study and were within the prespecified noninferiority range. No significant between-group differences were observed in lung function, rescue medication use, response to therapy, exacerbation rates, or adverse events. At most of the weeks assessed, there were no between-group differences in asthma symptoms. Most adverse events were mild-to-moderate. Conclusion. MF-DPI 400 mu g BID was therapeutically equivalent to FP-DPI 500 mu g BID in patients with moderate-to-severe persistent asthma.

AB - Background. Inhaled corticosteroids (ICSs) are one of the suggested first-line therapies for patients with persistent asthma of moderate severity. Methods: The efficacy and safety of mometasone furoate (MF) 400 mu g twice daily (BID) and fluticasone propionate (FP) 500 mu g BID administered for 12 weeks via dry powder inhaler (DPI) were compared in a noninferiority trial, in adults with moderate-to-severe persistent asthma. The primary variable was the change from baseline in AM peak expiratory flow rate (PEFR). Pm PEFR, forced expiratory volume in 1 second (FEV1), asthma symptoms, rescue medication use, response to therapy, exacerbation rates, and adverse events were also assessed. Results. The lower bound of 95% CIs for treatment differences in the primary variable ranged from 2.6% to 5.6% throughout the 12-week study and were within the prespecified noninferiority range. No significant between-group differences were observed in lung function, rescue medication use, response to therapy, exacerbation rates, or adverse events. At most of the weeks assessed, there were no between-group differences in asthma symptoms. Most adverse events were mild-to-moderate. Conclusion. MF-DPI 400 mu g BID was therapeutically equivalent to FP-DPI 500 mu g BID in patients with moderate-to-severe persistent asthma.

KW - asthma

KW - fluticasone propionate

KW - mometasone furoate

KW - noninferiority trial

KW - beta(2)-agonist

KW - pituitary-adrenal axis

KW - efficacy

KW - safety

KW - suppression

U2 - 10.1080/02770900801890646

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SN - 0277-0903

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ER -