A pharmacokinetic/pharmacodynamic study comparing arformoterol tartrate inhalation solution and racemic formoterol dry powder inhaler in subjects with chronic obstructive pulmonary disease

Pulmonary Pharmacology and Therapeutics

Volumn 21, Issue 4, 2008, Pages 657-662

  Kharidia, J ^a   Fogarty, C M ^b   LaForce, C F ^c   Maier, G ^a   Hsu, R ^a   Dunnington, K M ^d   Curry, L ^a   Baumgartner, R A ^a   Hanrahan, J P ^a  

^a SUNOVION PHARMACEUTICALS INC   (United States)

^b Spartanburg Medical Research ^*  (United States)

^c North Carolina Clinical Research   (United States)

^d PRA HEALTH SCIENCES   (United States)

Author keywords

Arformoterol; Chronic obstructive pulmonary disease; Enantioselectivity; Inhalation solution; Long acting beta2 adrenergic agonists; Pharmacodynamics; Pharmacokinetics

Indexed keywords

ARFORMOTEROL; FORMOTEROL; FORMOTEROL FUMARATE;

ADULT; AGED; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFICACY; DRY POWDER; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; MALE; MULTICENTER STUDY; NEBULIZATION; OPEN STUDY; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, INHALATION; AGED; AREA UNDER CURVE; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; ETHANOLAMINES; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; NEBULIZERS AND VAPORIZERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; STEREOISOMERISM;

EID: 47049092675     PISSN: 10945539     EISSN: 15229629     Source Type: Journal    
DOI: 10.1016/j.pupt.2008.03.003     Document Type: Article

References (17)

1. Patil P.A., and Kothekar M.A. Development of safer molecules through chirality. Indian J Med Sci 60 10 (2006) 427-437
2. McConathy J., and Owens M.J. Stereochemistry in drug action. Prim Care Companion. J Clin Psychiat 5 2 (2003) 70-73
3. Hutt A.J. The development of single-isomer molecules: why and how. CNS Spectr 7 4 Suppl. 1 (2002) 14-22
4. Handley D.A., Senanayake C.H., Dutczak W., et al. Biological actions of formoterol isomers. Pulm Pharmacol Ther 15 2 (2002) 135-145
5. 2-agonists on ACH release and smooth muscle contraction in the trachea. Am J Physiol 274 (1998) L32-L38
6. Schmidt D., Kallstrom B.L., Waldeck B., et al. The effect of the enantiomers of formoterol on inherent and induced tone in guinea-pig trachea and human bronchus. Naunyn Schmiedebergs Arch Pharmacol 361 4 (2000) 405-409
7. Bauer A, McGlynn P, Bovet L, et al. The influence of breathing pattern during nebulization on the delivery of arformoterol using a breath simulator. J Aerosol Med 2007; submitted for publication.
8. Foradil [package insert]. 2006.
9. Zhou D, Huo M, Hsu SH, et al. Determination of (R,R)-formoterol and (S,S)-formoterol in human plasma using chiral liquid chromatography-tandem mass spectrometry (Abstract). 2006. W4004.
10. World Medical Association declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. J Am Med Assoc 277 11 (1997) 925-926
11. Fletcher C. Standardised questionnaire on respiratory symptoms: a statement prepared and approved by the MRC Committee on the Aetiology of Chronic Bronchitis (MRC breathlessness score). Br Med J 2 (1960) 1665
12. FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry: bioanalytical method validation. 2001. p. 1-22.
13. AARC Clinical Practice Guideline: Spirometry, 1996 update. Respir Care 1996;41(7):629-36.
14. Suzuki J., Broeyer F., Cohen A., et al. Pharmacokinetics of PC-SOD, a lecithinized recombinant superoxide dismutase, after single- and multiple-dose administration to healthy Japanese and Caucasian volunteers. J Clin Pharmacol 48 2 (2008) 184-192
15. Krishnan S., and Zhang Y. Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study. J Clin Pharmacol 48 3 (2008) 293-302
16. FDA, Center for Drug Evaluation and Research. Guidance for industry: statistical approaches to establishing bioequivalence. 2001. p. 1-45.
17. Lotvall J., Palmqvist M., Ankerst J., et al. The effect of formoterol over 24 h in patients with asthma: the role of enantiomers. Pulm Pharmacol Ther 18 2 (2005) 109-113