Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma

Anjuli S. Nayak, Charles Banov, Jonathan Corren, Barry K. Feinstein, Anthony Floreani, Bruce F. Friedman, Alan Goldsobel, Gregory M. Gottschlich, Paul J. Hannaway, Kathy L. Lampl, Robert J. Lapidus, Michael Lawrence, William Lumry, Zev Munk, David Pearlman, Anthony T. Scardella, Eric J. Schenkel, Allen T. Segal, Nathan Segall, Bernard Silverman & 3 others Lucy Shneyer, Keith B. Nolop, Judy E. Harrison

Research output: Contribution to journalArticle

Abstract

Background: Although inhaled glucocorticoids are recommended for all stages of persistent asthma, compliance with long-term therapy is often poor, leading to significant morbidity and mortality. A simplified, once-daily dosing regimen may foster improved compliance. Objective: To compare the efficacy and safety of once-daily (AM) administration of mometasone furoate dry powder inhaler (MF DPI) 200 μg and 400 μg with placebo in patients with asthma previously maintained only on short-acting inhaled beta-adrenergic receptor agonists. Methods: This was a 12-week, double-blind, placebo- controlled, parallel group study. The mean change from baseline to endpoint (last treatment visit) for FEV1 was the primary efficacy variable. Results: At endpoint, both doses of MF DPI were significantly more effective than placebo (P ≤ .05) in improving FEV1. Based on morning peak expiratory flow rate, once-daily MF DPI 400 μg was more effective than placebo (P ≤ .001) at endpoint. Both active treatments also demonstrated improvement at endpoint in asthma symptom scores, physician-evaluated response to therapy and use of rescue medication. Although both MF DPI dosages were efficacious, MF DPI 400 μg provided additional improvement in some measures of pulmonary function (eg, morning PEFR) when these agents were administered once daily in the morning. Both doses of MF DPI were well tolerated and treatment-related adverse events occurred at a similar incidence among the three treatment groups. Conclusions: The results of this study indicate that once-daily (AM) MF DPI provides a convenient and effective treatment option for patients with mild or moderate persistent asthma.

Original languageEnglish (US)
Pages (from-to)417-424
Number of pages8
JournalAnnals of Allergy, Asthma and Immunology
Volume84
Issue number4
StatePublished - Apr 2000
Externally publishedYes

Fingerprint

Mometasone Furoate
Dry Powder Inhalers
Asthma
Placebos
Peak Expiratory Flow Rate
Therapeutics
Adrenergic beta-Agonists
Glucocorticoids
Compliance

ASJC Scopus subject areas

  • Immunology and Allergy

Cite this

Nayak, A. S., Banov, C., Corren, J., Feinstein, B. K., Floreani, A., Friedman, B. F., ... Harrison, J. E. (2000). Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. Annals of Allergy, Asthma and Immunology, 84(4), 417-424.

Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. / Nayak, Anjuli S.; Banov, Charles; Corren, Jonathan; Feinstein, Barry K.; Floreani, Anthony; Friedman, Bruce F.; Goldsobel, Alan; Gottschlich, Gregory M.; Hannaway, Paul J.; Lampl, Kathy L.; Lapidus, Robert J.; Lawrence, Michael; Lumry, William; Munk, Zev; Pearlman, David; Scardella, Anthony T.; Schenkel, Eric J.; Segal, Allen T.; Segall, Nathan; Silverman, Bernard; Shneyer, Lucy; Nolop, Keith B.; Harrison, Judy E.

In: Annals of Allergy, Asthma and Immunology, Vol. 84, No. 4, 04.2000, p. 417-424.

Research output: Contribution to journalArticle

Nayak, AS, Banov, C, Corren, J, Feinstein, BK, Floreani, A, Friedman, BF, Goldsobel, A, Gottschlich, GM, Hannaway, PJ, Lampl, KL, Lapidus, RJ, Lawrence, M, Lumry, W, Munk, Z, Pearlman, D, Scardella, AT, Schenkel, EJ, Segal, AT, Segall, N, Silverman, B, Shneyer, L, Nolop, KB & Harrison, JE 2000, 'Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma', Annals of Allergy, Asthma and Immunology, vol. 84, no. 4, pp. 417-424.
Nayak AS, Banov C, Corren J, Feinstein BK, Floreani A, Friedman BF et al. Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. Annals of Allergy, Asthma and Immunology. 2000 Apr;84(4):417-424.
Nayak, Anjuli S. ; Banov, Charles ; Corren, Jonathan ; Feinstein, Barry K. ; Floreani, Anthony ; Friedman, Bruce F. ; Goldsobel, Alan ; Gottschlich, Gregory M. ; Hannaway, Paul J. ; Lampl, Kathy L. ; Lapidus, Robert J. ; Lawrence, Michael ; Lumry, William ; Munk, Zev ; Pearlman, David ; Scardella, Anthony T. ; Schenkel, Eric J. ; Segal, Allen T. ; Segall, Nathan ; Silverman, Bernard ; Shneyer, Lucy ; Nolop, Keith B. ; Harrison, Judy E. / Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. In: Annals of Allergy, Asthma and Immunology. 2000 ; Vol. 84, No. 4. pp. 417-424.
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AU - Nayak, Anjuli S.

AU - Banov, Charles

AU - Corren, Jonathan

AU - Feinstein, Barry K.

AU - Floreani, Anthony

AU - Friedman, Bruce F.

AU - Goldsobel, Alan

AU - Gottschlich, Gregory M.

AU - Hannaway, Paul J.

AU - Lampl, Kathy L.

AU - Lapidus, Robert J.

AU - Lawrence, Michael

AU - Lumry, William

AU - Munk, Zev

AU - Pearlman, David

AU - Scardella, Anthony T.

AU - Schenkel, Eric J.

AU - Segal, Allen T.

AU - Segall, Nathan

AU - Silverman, Bernard

AU - Shneyer, Lucy

AU - Nolop, Keith B.

AU - Harrison, Judy E.

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N2 - Background: Although inhaled glucocorticoids are recommended for all stages of persistent asthma, compliance with long-term therapy is often poor, leading to significant morbidity and mortality. A simplified, once-daily dosing regimen may foster improved compliance. Objective: To compare the efficacy and safety of once-daily (AM) administration of mometasone furoate dry powder inhaler (MF DPI) 200 μg and 400 μg with placebo in patients with asthma previously maintained only on short-acting inhaled beta-adrenergic receptor agonists. Methods: This was a 12-week, double-blind, placebo- controlled, parallel group study. The mean change from baseline to endpoint (last treatment visit) for FEV1 was the primary efficacy variable. Results: At endpoint, both doses of MF DPI were significantly more effective than placebo (P ≤ .05) in improving FEV1. Based on morning peak expiratory flow rate, once-daily MF DPI 400 μg was more effective than placebo (P ≤ .001) at endpoint. Both active treatments also demonstrated improvement at endpoint in asthma symptom scores, physician-evaluated response to therapy and use of rescue medication. Although both MF DPI dosages were efficacious, MF DPI 400 μg provided additional improvement in some measures of pulmonary function (eg, morning PEFR) when these agents were administered once daily in the morning. Both doses of MF DPI were well tolerated and treatment-related adverse events occurred at a similar incidence among the three treatment groups. Conclusions: The results of this study indicate that once-daily (AM) MF DPI provides a convenient and effective treatment option for patients with mild or moderate persistent asthma.

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