Chest
Clinical InvestigationsAsthmaEffects of Mometasone Furoate Dry Powder Inhaler and Beclomethasone Dipropionate Hydrofluoroalkane and Chlorofluorocarbon on the Hypothalamic-Pituitary-Adrenal Axis in Asthmatic Subjects
Section snippets
Subjects
Male and female subjects with mild asthma 18 to 65 years old were eligible for the study. All subjects had a history of asthma for ≥ 6 months and a FEV1 of ≥ 80% predicted at screening after withholding short- and long-acting β2-receptor agonist treatment for 6 h and 48 h, respectively. At screening or within the previous 12 months, subjects had to demonstrate reversibility of airflow obstruction, defined as a ≥ 12% (or ≥ 200 mL absolute volume) increase in FEV1 after albuterol administration.
Demographics
A total of 53 subjects were enrolled and randomized to receive MF-DPI (n = 18), HFA-BDP (n = 18), or CFC-BDP (n = 17). Four subjects were discontinued from the study due to protocol ineligibility (MF-DPI, n = 1; HFA-BDP, n = 1; CFC-BDP, n = 2). Five subjects were excluded from the per protocol population; one subject in the MF-DPI group had a low serum cortisol at screening, while three subjects were excluded for using oral contraceptives (HFA-BDP, n = 1; CFC-BDP, n = 2) and one subject was
Discussion
This study compared the effect of MF-DPI on the HPA axis with that of another commonly used ICS, BDP, in subjects with asthma. The results demonstrate that a similar magnitude of HPA-axis suppression occurred with BDP via HFA and CFC MDI, despite the differences in BDP doses: 200 μg bid vs 400 μg bid. This confirms previous findings by Jackson and Lipworth1314 indicating greater systemic bioavailability and enhanced cortisol suppression with the HFA formulation of BDP vs the CFC formulation.
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Impact of study design on the evaluation of inhaled and intranasal corticosteroids' effect on hypothalamic-pituitary-adrenal axis function
2014, Journal of Pharmaceutical SciencesMometasone furoate nasal spray is safe and effective for 1-year treatment of children with perennial allergic rhinitis
2009, International Journal of Pediatric OtorhinolaryngologyCitation Excerpt :Higher doses of MF administered via dry powder inhaler (DPI) have demonstrated minimal impact on adrenal function. In a 14-day study of adult subjects with mild asthma, a once-daily dose of MF DPI 400 μg had significantly lower effects on the HPA axis than BDP metered-dose inhaler 200 μg twice daily and 400 μg twice daily, as assessed by 24-h serum cortisol concentration curves and urinary free cortisol excretion [21]. Only intranasal BDP has been reported to cause growth retardation when administered twice daily for 1 year to children aged 6–9 years with PAR [22].
16 Drugs acting on the respiratory tract
2008, Side Effects of Drugs AnnualThe burden of exacerbations in mild asthma: A systematic review
2020, ERJ Open Research
This study supported by Integrated Therapeutics Group, Inc., a subsidiary of Schering-Plough Corporation, Kenilworth, NJ.
This study was performed at Simbec Research Ltd, Merthyr Tydfil, Cardiff, UK.