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Effects of Mometasone Furoate Administered Via a Dry Powder Inhaler Once Daily in the Evening on Nocturnal Lung Function and Sleep Parameters in Patients with Moderate Persistent Asthma

A Randomized, Double-Blind, Placebo-Controlled Pilot Study

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Abstract

Background and objective: Nocturnal symptoms are common in asthma patients and have the potential for considerable clinical effects due to a lack of sleep and persistent daytime symptoms of somnolence and activity impairment. The primary objective of this investigation was to determine the effect of a 14-day course of once-daily evening administration of mometasone furoate 400 µg administered via a dry powder inhaler (MF-DPI 400 µg qd pm) on the overnight decline in pulmonary function observed in patients with nocturnal asthma.

Methods: Eligible enrollees were between the ages of 18 and 60 years and had established mild to moderate asthma, with an improvement in forced expiratory volume in 1 second (FEV1) of >15% after administration of inhaled salbutamol (albuterol) 200 µg. All enrolled patients had a history of nocturnal asthma. Enrollees were randomized to receive MF-DPI 400 µg qd pm or placebo administered between 6pm and 8pm for 14 days. The primary outcome evaluated in the study was reduction in nocturnal decline in evening (8pm) to morning (6am) FEV1 values. Secondary outcomes included reduction in nocturnal decline in evening to morning peak expiratory flow rate (PEFR), polysomnographic indices of sleep, and psychometric indices (Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire [NRQLQ], 36-item Short Form of the Medical Outcomes Survey [SF-36], and Asthma Quality of Life Questionnaire [AQLQ]).

Results: A total of 20 patients were randomized and completed all phases of the study. No significant differences were observed between treatment groups in the primary outcome of nocturnal decline in FEV1 from pretreatment to end of treatment. Likewise, there was no significant difference between treatment groups in polysomnographic indices of sleep or quality-of-life assessments. However, there was a trend toward improvement in the activity scale of the AQLQ assessment in the MF-DPI 400 µg qd pm treatment group.

Conclusion: No significant treatment effect on nocturnal pulmonary function, sleep indices or quality of life was observed with 14-day administration of MF-DPI 400 µg qd pm. These findings are limited by the small sample size and the short treatment period evaluated. Future studies are warranted to study the effects of MF-DPI therapy in patients with nocturnal asthma.

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Acknowledgements

This study was funded by Schering-Plough. Editorial assistance was provided by Erin P. Scott, PhD. This assistance was also funded by Schering-Plough. John Krouse has acted as a consultant to Schering-Plough and Alcon, has received honoraria from Schering-Plough, Merck and sanofi-aventis, holds stock in Schering-Plough and Alcon, and has received research grants from Schering-Plough. Helene Krouse has received honoraria from sanofi-aventis and Alcon, holds stock in Viropharma and Schering-Plough, and has received research grants from Schering-Plough. James Janisse has no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Department of Otolaryngology, Wayne State University, Detroit, Michigan, USA

    John H. Krouse, Helene J. Krouse & James J. Janisse

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  1. John H. Krouse
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  2. Helene J. Krouse
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  3. James J. Janisse
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Correspondence to John H. Krouse.

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Krouse, J.H., Krouse, H.J. & Janisse, J.J. Effects of Mometasone Furoate Administered Via a Dry Powder Inhaler Once Daily in the Evening on Nocturnal Lung Function and Sleep Parameters in Patients with Moderate Persistent Asthma. Clin. Drug Investig. 29, 51–58 (2009). https://doi.org/10.2165/0044011-200929010-00005

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