Pharmacokinetics and safety of aclidinium bromide, a muscarinic antagonist, in adults with normal or impaired renal function: A phase I, open-label, single-dose clinical trial

Clinical Therapeutics

Volumn 32, Issue 10, 2010, Pages 1798-1812

  Schmid, Karin ^a   Pascual, Silvia ^b   Gil, Esther Garcia ^b   Ortiz, Stephan ^c   Jansat, Josep M ^b  

^a APEX GmbH   (Germany)

^b Almirall SA ^*  (Spain)

^c FOREST RESEARCH INSTITUTE   (United States)

Author keywords

Aclidinium bromide; COPD; Pharmacokinetics; Renal insufficiency; Safety

Indexed keywords

ACLIDINIUM BROMIDE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EXCRETION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; FATIGUE; FEMALE; HEADACHE; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; MALE; MAXIMUM PLASMA CONCENTRATION; PHASE 1 CLINICAL TRIAL; RESTLESSNESS; SOMNOLENCE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; AGED; FEMALE; HUMANS; KIDNEY FUNCTION TESTS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RENAL INSUFFICIENCY; SEVERITY OF ILLNESS INDEX; TROPANES; YOUNG ADULT;

EID: 78650603689     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.09.002     Document Type: Article

References (26)

1. Rabe KF, Hurd S, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007, 176:532-555.
2. van Durme YM, Verhamme KM, Stijnen T, et al. Prevalence, incidence, and lifetime risk for the development of COPD in the elderly: The Rotterdam study. Chest. 2009, 135:368-377.
3. Rowe JW, Andres R, Tobin JD, et al. The effect of age on creatinine clearance in men: A cross-sectional and longitudinal study. J Gerontol. 1976, 31:155-163.
4. Elwing J, Panos RJ Pulmonary hypertension associated with COPD. Int J Chron Obstruct Pulmon Dis. 2008, 3:55-70.
5. Chatila WM, Thomashow BM, Minai OA, et al. Comorbidities in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008, 5:549-555.
6. Masuo K, Rakugi H, Ogihara T, et al. Cardiovascular and renal complications of type 2 diabetes in obesity: Role of sympathetic nerve activity and insulin resistance. Curr Diabetes Rev. 2010, 6:58-67.
7. Stolar M Glycemic control and complications in type 2 diabetes mellitus. Am J Med. 2010, 123(Suppl 3):S3-S11.
8. Barnes PJ The role of anticholinergics in chronic obstructive pulmonary disease. Am J Med. 2004, 117(Suppl 12A):24S-32S.
9. Magnussen H, Ribera Llovera A, Kirsten A-M, et al. Efficacy and safety of aclidinium bromide 400 μ BID compared with placebo and tiotropium in patients with moderate to severe COPD. Am J Respir Crit Care Med. 2010, 181:A4440.
10. Gavaldà A, Miralpeix M, Ramos I, et al. Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profile. J Pharmacol Exp Ther. 2009, 331:740-751.
11. Sentellas S, Ramos I, Albertf J, et al. Aclidinium bromide, a new, long-acting, inhaled muscarinic antagonist: In vitro plasma inactivation and pharmacological activity of its main metabolites. Eur J Pharm Sci. 2010, 39:283-290.
12. Jansat JM, Lamarca R, Garcia Gil E, Ferrer P Safety and pharmacokinetics of single doses of aclidinium bromide, a novel long-acting, inhaled antimuscarinic, in healthy subjects. Int J Clin Pharmacol Ther. 2009, 47:460-468.
13. Jansat JM, Lamarca R, de Miquel G, et al. Safety and pharmacokinetics of multiple doses of aclidinium bromide, a novel long-acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease, in healthy participants. J Clin Pharmacol. 2009, 49:1239-1246.
14. Gras J, Llupià J, Llenas J, et al. The preclinical urinary and renal safety profile of aclidinium bromide, a novel longacting anticholinergic drug. Eur Respir J. 2008, 32(Suppl 52):637s.
15. Türck D, Weber W, Sigmund R, et al. Pharmacokinetics of intravenous, single-dose tiotropium in subjects with different degrees of renal impairment. J Clin Pharmacol. 2004, 44:163-172.
16. Cockcroft D, Gault M Prediction of creatinine clearance from serum creatinine. Nephron. 1976, 16:31-41.
17. Ethical principles for medical research involving human subjects. JAMA. 2000, 284:3043-3045. World Medical Association Declaration of Helsinki.
18. Dixon JR The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur. 1998, 6:65-74.
19. Bazett H An analysis of the time-relations of electrocar-diograms. Heart. 1920, 7:353-370.
20. Guidance for Industry: Bioanalytical Method Validation 2001, Food and Drug Administration, Center for Drug Evaluation and Research and Center for Veterinary Medicine, US Department of Health and Human Services, Rock-ville, Md.
21. Lehmann EL, D'Abrera HJ Nonparametrics: Statistical Methods Based on Ranks 1975, Holden-Day, San Francisco, Calif.
22. Fisher L, van Belle G Biostatistics: A Methodology for the Health Sciences 1993, John Wiley & Sons, New York, NY.
23. Corrigan B, Feltner DE, Ouellet D, et al. Effect of renal impairment on the pharmacokinetics of PD 0200390, a novel ligand for the voltage-gated calcium channel alpha-2-delta subunit. Br J Clin Pharmacol. 2009, 68:174-180.
24. Khosravan R, Toh M, Garrett M, et al. Pharmacokinetics and safety of sunitinib malate in subjects with impaired renal function. J Clin Pharmacol. 2010, 50:472-481.
25. van Noord JA, Cornelissen PJ, Aumann JL, et al. The efficacy of tiotropium administered via Respimat Soft Mist Inhaler or Handi-Haler in COPD patients. Respir Med. 2009, 103:22-29.
26. Turck D, Weber W, Sigmund R, et al. Pharmacokinetics of intravenous, single-dose tiotropium in subjects with different degrees of renal impairment. J Clin Pharmacol. 2004, 44:163-172.