Chest
Original ResearchAsthmaOnce-Daily Evening Dosing of Mometasone Furoate Administered via a Dry Powder Inhaler Does Not Adversely Affect the Hypothalamic-Pituitary-Adrenal Axis
Section snippets
Methods
This single-site study was a randomized, investigator-blind, parallel-group, placebo-controlled trial conducted in adults with mild-to-moderate asthma. Written informed consent was received from all eligible subjects, and the trial was conducted in accordance with the Good Clinical Practice guidelines. This study was initiated April 16, 2001 and completed June 14, 2001.
Subject Demographics and Baseline Characteristics
A total of 48 subjects were randomized to participate, and all subjects completed the 42-day study (Fig 1B). Subject demographics and baseline characteristics are summarized in Table 1. A total of 16 men and 32 women participated in the study with a mean age of 39.5 years. Treatment groups were comparable in terms of age, weight, height, and BMI. Reported FEV1 at baseline was also comparable between treatment groups, ranging from 67.5% to 70.6%, and all subjects had a history of mild or
Discussion
We found that 42 days of treatment with MF-DPI 400 μg daily in the evening, delivered in either 2 × 200 or 1 × 400 μg dosing strategies, had no significant effect on HPA-axis activity. This study is unique because the effects of evening ICS dosing were investigated and found to have no significant effect on HPA-axis function. These findings are consistent with previous analyses of MF-DPI dosing regimens, including once-daily evening dosing of 200 μg, all of which reported nonsignificant effects
Conclusions
The results of this study support the systemic safety of MF-DPI 400 μg daily delivered in the evening. These results suggest that a once-evening dosing regimen of MF-DPI is safe and does not suppress HPA-axis function in adult patients with mild-to-moderate asthma.
Acknowledgments
Author contributions: Dr Kosoglou had full access to all the data and takes full responsibility for the integrity and accuracy of the data and manuscript.
Dr Kosoglou: contributed to the analysis and interpretation of the data, critically revised the manuscript for intellectual content, and approved the final version.
Dr Cutler: contributed to the analysis and interpretation of the data, critically revised the manuscript for intellectual content, and approved the final version.
Dr Staudinger:
References (0)
Cited by (9)
Impact of study design on the evaluation of inhaled and intranasal corticosteroids' effect on hypothalamic-pituitary-adrenal axis function
2014, Journal of Pharmaceutical SciencesHypothalamic-pituitary-adrenal axis effects of mometasone furoate/formoterol fumarate vs fluticasone propionate/salmeterol administered through metered-dose inhaler
2013, ChestCitation Excerpt :Taken together, these results suggest that low-dose MF/F MDI does not have demonstrable effects on plasma cortisol levels, whereas high-dose MF/F or FP/S MDI appeared to suppress plasma cortisol levels in adults with mild to moderate asthma, although these effects are not considered clinically significant. These results are consistent with those previously published for MF and FP administered as single-ingredient products through MDI.9,10 Over the years, a number of approaches have been used to assess HPA axis function, including the measurement of a single morning (8:00 am) cortisol value, a 24-h serum/plasma cortisol AUC, or 24-h urinary free cortisol excretion and the response to cosyntropin stimulation.9
Efficacy and Safety Profile of Fluticasone Furoate Administered Once Daily in the Morning or Evening: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial in Adult and Adolescent Patients With Persistent Bronchial Asthma
2012, Clinical TherapeuticsCitation Excerpt :Some efficacy benefits have been reported to be associated with evening dosing relative to morning.11,12 Morning dosing has been thought to minimize suppression of the hypothalamic-pituitary-adrenal (HPA) axis relative to dosing at other times.13 However, some more recent studies have not found HPA axis function to be adversely affected by evening dosing.11,12,14,15 The ICS fluticasone furoate (FF) is currently in development as a monotherapy for asthma and in combination with the long-acting β2 agonist vilanterol for asthma and chronic obstructive pulmonary disease.
Particle size and small airway effects of mometasone furoate delivered by dry powder inhaler
2013, Allergy and Asthma Proceedings
Funding/Support: This study was supported by Schering-Plough.
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