Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: Randomised, double-blind, placebo-controlled study

Clinical Respiratory Journal

Volumn 7, Issue 4, 2013, Pages 397-406

  Allen, Ann ^a   Schenkenberger, Isabelle ^b   Trivedi, Roopa ^c   Cole, Jeremy ^d   Hicks, Wesley ^a   Gul, Nadeem ^a   Jacques, Loretta ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

^b Medizinische Leitung   (Germany)

^c GLAXOSMITHKLINE   (United States)

^d IPS Research Company   (United States)

Author keywords

Asthma; Cortisol; Fluticasone furoate; Hypothalamic pituitary adrenal axis; Inhaled corticosteroid; Long acting beta2 agonist; Vilanterol

Indexed keywords

CORTICOSTEROID; FLUTICASONE FUROATE PLUS VILANTEROL; HYDROCORTISONE; PLACEBO; PREDNISOLONE; SALBUTAMOL;

ADOLESCENT; ADOLESCENT DISEASE; ADULT; ADULT DISEASE; AGED; AREA UNDER THE CURVE; ARTICLE; ASTHMA; CARDIOVASCULAR EFFECT; CHILD; CONTROLLED STUDY; DETERIORATION; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EXCRETION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPHONIA; FACIAL NERVE PARALYSIS; FEMALE; FORCED EXPIRATORY VOLUME; HEART PALPITATION; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYDROCORTISONE URINE LEVEL; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MEDICATION COMPLIANCE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROVOCATION TEST; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SCHOOL CHILD; SINUSITIS; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; THROAT IRRITATION; THRUSH; TIME TO MAXIMUM PLASMA CONCENTRATION; VARICOSIS;

ASTHMA; CORTISOL; FLUTICASONE FUROATE; HYPOTHALAMIC-PITUITARY-ADRENAL AXIS; INHALED CORTICOSTEROID; LONG-ACTING BETA2 AGONIST; VILANTEROL;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; AGED; ANDROSTADIENES; ASTHMA; BENZYL ALCOHOLS; CHILD; CHLOROBENZENES; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GLUCOCORTICOIDS; HUMANS; HYDROCORTISONE; HYPOTHALAMO-HYPOPHYSEAL SYSTEM; MALE; MIDDLE AGED; PITUITARY-ADRENAL SYSTEM; PLACEBOS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84884813298     PISSN: 17526981     EISSN: 1752699X     Source Type: Journal    
DOI: 10.1111/crj.12026     Document Type: Article

References (20)

1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2011. Available at: http://www.ginasthma.com/ (accessed 10 January 2013).
2. Price D, Robertson A, Bullen K, Rand C, Horne R, Staudinger H. Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study. BMC Pulm Med. 2010;10: 1.
3. Jones C, Santanello NC, Boccuzzi SJ, Wogen J, Strub P, Nelsen LM. Adherence to prescribed treatment for asthma: evidence from pharmacy benefits data. J Asthma. 2003;40: 93-101.
4. Biggadike K, Bledsoe RK, Hassell AM, Kirk BE, McLay IM, Shewchuk LM, Stewart EL. X-ray crystal structure of the novel enhanced-affinity glucocorticoid agonist fluticasone furoate in the glucocorticoid receptor-ligand binding domain. J Med Chem. 2008;51: 3349-3352.
5. Bateman ED, Bleecker ER, Lötvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Respir Med. 2012;106: 642-650.
6. Bleecker ER, Bateman ED, Busse WW, Woodcock A, Frith L, House KW, Jacques L, Davis AM, Haumann B, Lötvall J. Once-daily fluticasone furoate is efficacious in asthma patients symptomatic on low-dose inhaled corticosteroids. Ann Allergy Asthma Immunol. 2012;109: 353-358.e4.
7. Busse WW, Bleecker ER, Bateman ED, Lötvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax. 2012;67: 35-41.
8. Salter M, Biggadike K, Matthews JL, West MR, Haase MV, Farrow SN, Uings IJ, Gray DW. Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. Am J Physiol Lung Cell Mol Physiol. 2007;293: L660-667.
9. Lötvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B. 24h duration of the novel LABA vilanterol trifenatate in asthma patients treated with ICSs. Eur Respir J. 2012;40: 570-579.
10. Lötvall J, Bakke P, Bjermer L, Steinshamn S, Crim C, Sanford L, Scott-Wilson C, Haumann B. Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial. BMJ Open. 2012;2: e000370.
11. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: a systemic review and meta-analysis. Arch Intern Med. 1999;159: 941-955.
12. Masoli M, Weatherall M, Holt S, Shirtcliffe P, Beasley R. Inhaled fluticasone propionate and adrenal effects in adult asthma: systematic review and meta-analysis. Eur Respir J. 2006;28: 960-967.
13. Clark DJ, Grove A, Cargill RI, Lipworth BJ. Comparative adrenal suppression with inhaled budesonide and fluticasone propionate in adult asthmatic patients. Thorax. 1996;51: 262-266.
14. Bernstein DI, Allen DB. Evaluation of tests of hypothalamic-pituitary-adrenal axis function used to measure effects of inhaled corticosteroids. Ann Allergy Asthma Immunol. 2007;98: 118-127.
15. National Institutes for Health (NIH). Guidelines for the Diagnosis and Management of Asthma - Expert Panel Report 3, 2007. Bethesda, MD, U.S. Department of Health and Human Services, 2007. NIH Publication No. 07-4051.
16. Barnes PJ. Inhaled corticosteroids. Pharmaceuticals. 2010;3: 514-540.
17. Ahmet A, Kim H, Spier S. Adrenal suppression: a practical guide to the screening and management of this under-recognized complication of inhaled corticosteroid therapy. Allergy Asthma Clin Immunol. 2011;7: 13.
18. Kempsford R, Allen A, Bareille P, Bishop H, Hamilton M, Cheesbrough A. The safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled fluticasone furoate (FF) and vilanterol (VI) are unaffected by administration in combination. Eur Respir J. 2011;38(Suppl. 55): 824s. [abstract].
19. Allen A, Bianco J, Bal J, Tombs L, Kempsford R. The absolute bioavailability of fluticasone furoate (FF) and vilanterol (VI) trifenatate following inhaled administration in combination in healthy subjects. Eur Respir J. 2011;38(Suppl. 55): 3976s. [abstract].
20. Henzen C, Suter A, Lerch E, Urbinelli R, Schorno XH, Briner VA. Suppression and recovery of adrenal response after short-term, high-dose glucocorticoid treatment. Lancet. 2000;355: 542-545.