Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GW870086: Two randomised studies

Current Drug Therapy

Volumn 8, Issue 2, 2013, Pages 76-85

  Allen, Ann ^a   Bareille, Philippe ^a   Hardes, Kelly ^a   Robertson, Jonathan ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Cortisol; GW870086; Pharmacokinetics; Safety

Indexed keywords

GW 870086; HYDROCORTISONE; PLACEBO;

ADULT; AREA UNDER THE CURVE; ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG ELIMINATION; DRUG EXPOSURE; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRY POWDER INHALER; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYDROCORTISONE URINE LEVEL; LUNG FUNCTION TEST; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; RHINOPHARYNGITIS; SINGLE DRUG DOSE; SORE THROAT; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; YOUNG ADULT;

EID: 84887808956     PISSN: 15748855     EISSN: 10657630     Source Type: Journal    
DOI: 10.2174/15748855113089990004     Document Type: Article

References (19)

1. From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2010. http://www. ginasthma. org/(Accessed: October 03, 2011).
2. Fanta CH. Asthma. N Engl J Med 2009; 360: 1002-14.
3. Barnes PJ. Corticosteroid effects on cell signalling. Eur Resp J 2006; 27: 413-26.
4. Newton R, Holden NS. Separating transrepression and transactivation: a distressing divorce for the glucocorticoid receptor? Mol Pharmacol 2007; 72: 799-809.
5. Hart LA, Krishnan VL, Adcock IM, Barnes PJ, Chung KF. Activation and localization of transcription factor, nuclear factor-B, in asthma. Am J Respir Crit Care Med 1998; 158: 1585-92.
6. Uings I, Needham D, Matthews J, et al. Discovery of GW870086: A potent anti-inflammatory steroid with a unique pharmacological profile. Br J Pharmacol (In press).
7. Lipworth BJ, Seckl JR. Measures for detectingsystemic bioactivity with inhaled and intranasal corticosteroids. Thorax 1997; 52: 476-82.
8. Bruni FM, De Luca G, Venturoli V, Boner AL. Intranasal corticosteroids and adrenal suppression. Neuroimmunomodulation 2009; 16: 353-62.
9. Crowley S. Inhaled glucocorticoids and adrenal function: an update. Paediatr Respir Rev 2003; 4: 153-61.
10. World Medical Association. Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. http://www. wma. net/en/30publications/10policies/b3/(AccessedOctober 31, 2011).
11. Thorsson L, Edsbacker S, Kallen A, Lofdahl C-G. Pharmacokinetics and systemic activity of fluticasone viaDiskus® and pMDI, and of budesonide via Turbuhaler®. Br J Pharmacol 2001; 52: 529-38.
12. Thorsson L, Dahlstrom K, Edsbacker S, Kallen A, Paulson J, Wiren J-E. Pharmacokinetics and systemic effects of inhaled fluticasone propionatein healthy subjects. Br J Clin Pharmacol 1997; 43: 155-61.
13. Grahnen A, Jansson B, Brundin RM, et al. A dose-response studycomparing suppression of plasma cortisol induced by fluticasonepropionate from Diskhaler and budesonide from Turbuhaler. Eur J Clin Pharmacol1997; 52: 261-7.
14. Donnelly R, Williams KM, Baker B, Badcock C-A, Day RO, Seale JP. Effects of budesonide and fluticasone on 24-hour plasma cortisol: adose-response study. Am J Respir Crit Care Med 1997; 156: 1746-51.
15. Lönnebo A, Grahnén A, Jansson B, Brundin RM, Ling-Andersson A, Eckernäs SA. An assessment of the systemic effects of single and repeated doses of inhaled fluticasone propionate and inhaled budesonide in healthy volunteers. Eur J Clin Pharmacol 1996; 49: 459-63.
16. Grahnen A, Eckernas S-A, Brundin RM, Ling Andersson A. An assessment of the systemic activity of single doses of inhaled fluticasone propionate in healthy volunteers. Br J Clin Pharmacol 1994; 38: 521-25.
17. Harrison TW, Tattersfield AE. Plasma concentrations of fluticasone propionate andbudesonide following inhalation from dry powderinhalers by healthy and asthmatic subjects. Thorax 2003; 58: 258-60.
18. Barnes PJ. Anti-inflammatory actions of glucocorticoids: molecular mechanisms. Clin Sci 1998; 94: 557-72.
19. Schacke H, Schottelius A, Doke W-D, et al. Dissociation of transactivation from transrepression by a selective glucocorticoid receptor agonist leads to separation of therapeutic effects from side effects. PNAS 2004; 101: 227-32.