Document Detail


Hypothalamic-pituitary-adrenal axis effects of mometasone furoate/formoterol fumarate vs fluticasone propionate/salmeterol administered through metered-dose inhaler.
MedLine Citation:
PMID:  24077095     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The effects of mometasone furoate and fluticasone propionate on the hypothalamic-pituitary-adrenal axis were compared when administered from combination metered-dose inhaler (MDI) products.
METHODS: In a randomized, open-label, placebo-controlled, parallel group study, 66 patients with mild to moderate asthma received one of the following four treatments bid through an MDI for 42 days: mometasone furoate/formoterol (MF/F) 200 μg/10 μg, MF/F 400 μg/10 μg, fluticasone propionate/salmeterol (FP/S) 460 μg/42 μg, or placebo. Plasma cortisol concentrations were measured over 24 h on days -1 (baseline) and 42. Geometric mean ratio (GMR) and 90% CI for mean change from baseline to day 42 in 24-h plasma cortisol area under the curve (AUC) were calculated for each treatment. If the 90% CI for the GMRs fell within 70% to 143%, treatments were deemed comparable.
RESULTS: Mean baseline cortisol AUCs were similar across groups. Mean cortisol effects (change from baseline) were similar for MF/F 400 μg/10 μg and FP/S 460 μg/42 μg (GMR, 119%; 90% CI, 101%-140%). Effects of MF/F 200 μg/10 μg on cortisol AUC were similar to placebo (GMR, 92%; 90% CI, 78%-110%), whereas MF/F 400 μg/10 μg and FP/S 460 μg/42 μg lowered cortisol AUC vs placebo (GMR, 78% [90% CI, 66%-92%] and 66% [90% CI 56%-78%], respectively). All treatments were generally well tolerated.
CONCLUSIONS: MF/F 400 μg/10 μg or FP/S 460 μg/42 μg bid through an MDI led to similar reductions from baseline in mean cortisol AUC (22% and 34% lower than placebo, respectively), whereas the effect of MF/F 200 μg/10 μg was similar to placebo.
Authors:
Teddy Kosoglou; James Hubbell; David L Cutler; Amy O Johnson-Levonas; Danlin Xu; Bhavna S Kantesaria; Kenneth Kim; S David Miller
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Chest     Volume:  144     ISSN:  1931-3543     ISO Abbreviation:  Chest     Publication Date:  2013 Dec 
Date Detail:
Created Date:  2013-12-05     Completed Date:  2014-03-13     Revised Date:  2014-06-11    
Medline Journal Info:
Nlm Unique ID:  0231335     Medline TA:  Chest     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1795-802     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Adolescent
Adult
Albuterol / administration & dosage,  analogs & derivatives*,  pharmacology,  therapeutic use
Androstadienes / administration & dosage,  pharmacology*,  therapeutic use
Anti-Inflammatory Agents / administration & dosage,  pharmacology,  therapeutic use
Asthma / blood,  drug therapy*
Bronchodilator Agents / administration & dosage,  pharmacology,  therapeutic use
Dose-Response Relationship, Drug
Drug Combinations
Drug Therapy, Combination
Ethanolamines / administration & dosage,  pharmacology*,  therapeutic use
Female
Glucocorticoids / administration & dosage,  pharmacology,  therapeutic use
Humans
Hydrocortisone / blood
Hypothalamo-Hypophyseal System / drug effects*,  physiology
Male
Metered Dose Inhalers*
Middle Aged
Pituitary-Adrenal System / drug effects*,  physiology
Pregnadienediols / administration & dosage,  pharmacology*,  therapeutic use
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Androstadienes; 0/Anti-Inflammatory Agents; 0/Bronchodilator Agents; 0/Drug Combinations; 0/Ethanolamines; 0/Glucocorticoids; 0/Pregnadienediols; 0/fluticasone, salmeterol drug combination; 5ZZ84GCW8B/formoterol; 83919-23-7/mometasone furoate; QF8SVZ843E/Albuterol; WI4X0X7BPJ/Hydrocortisone
Comments/Corrections
Comment In:
Chest. 2014 May;145(5):1175-6   [PMID:  24798853 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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