Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects

Respiratory Medicine

Volumn 99, Issue SUPPL. 1, 2005, Pages

  Kempsford, Rodger ^a   Handel, Malcolm ^b   Mehta, Rashmi ^c   De Silva, Mariza ^a   Daley Yates, Peter ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

^b PRINCE OF WALES HOSPITAL   (Australia)

^c GLAXOSMITHKLINE   (United States)

Author keywords

HFA 134a; Metered dose inhaler; Non CFC propellant; Pharmacodynamics; Pharmacokinetics; Propellant 11 12; Salmeterol

Indexed keywords

CHLOROFLUOROCARBON; NORFLURANE; PLACEBO; POTASSIUM; SALMETEROL;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIASTOLIC BLOOD PRESSURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG EFFECT; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; HEADACHE; HEART PALPITATION; HEART RATE; HUMAN; HUMAN EXPERIMENT; MALE; METERED DOSE INHALER; NORMAL HUMAN; PHARMACODYNAMICS; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; TREMOR; VOLUNTEER;

ADOLESCENT; ADULT; AEROSOL PROPELLANTS; ALBUTEROL; ANTI-ASTHMATIC AGENTS; ASTHMA; CHEMISTRY, PHYSICAL; CHLOROFLUOROCARBONS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HEART RATE; HUMANS; HYDROCARBONS, FLUORINATED; MALE; METERED DOSE INHALERS; MIDDLE AGED; POTASSIUM;

EID: 14844349948     PISSN: 09546111     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.rmed.2004.11.005     Document Type: Article

References (31)

1. M.R. Partridge Metered-dose inhalers and CFC: What respiratory physicians need to know Respir Med 88 1994 645-647
2. G. Boyd The continued need for metered-dose inhalers J Aerosol Med 8 Suppl. 1 1995 S9-S12
3. Command Paper No. 977; Treaty series 1990 (19); Montreal Protocol. Substances that deplete the ozone layer. Montreal, 16th September 1987
4. S. D'Souza Montreal protocol and essential use exemptions J Aerosol Med 8 1995 13-17
5. C.L. Leach Approaches and challenges to use freon propellant replacements Aerosol Sci Technol 22 1995 328-334
6. D.J. Alexander Safety of propellants J Aerosol Med 8 1995 29-34
7. D.J. Alexander S.E. Libretto An overview of the toxicology of HFA-134a (1,1,1,2-tetrafluoroethane) Hum Exp Toxicol 14 1995 715-720
8. L.I. Harrison D. Donnell J.L. Simmons et al. Twenty-eight day double-blind safety study of an HFA-134a inhalation aerosol system in healthy subjects J Pharm Pharmacol 48 1996 596-600
9. P.J. Thompson R.J. Davies W.F. Young et al. Safety of hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol Respir Med 92 1998 33-39
10. G.P. Ventresca Clinical pharmacology of HFA134a J Aerosol Med 8 Suppl 1 1995 S35-S39
11. L.H. Denyer S.M. Kirby P. Olsson et al. GR106642X, a non-chlorinated propellant for use in metered dose inhalers: Safety, tolerability and pharmacokinetics in healthy volunteers Br J Clin Pharmacol 37 Suppl. 1994 509P-510P
12. S.C. Taggart A. Custovic D.H. Richards et al. GR106642X: A new, non-ozone depleting propellant for inhalers BMJ 310 1995 1639-1640
13. A. Custovic S.C.O. Taggart A. Stuart A. Woodcock Efficacy of a new non-ozone depleting formulation for salbutamol J Pharm Med 5 1995 161-168
14. R.J. Hawksworth A.P. Sykes M. Faris et al. Albuterol HFA is as effective as albuterol CFC in preventing exercise-induced bronchoconstriction Ann Allergy Asthma Immunol 88 2002 473-477
15. W. Lumry R. Noveck S. Weinstein et al. Switching from Ventolin CFC to Ventolin HFA is well tolerated and effective in patients with asthma Ann Allergy Asthma Immunol 86 2001 297-303
16. A.B. Tonnel J. Bons M. Legendre et al. Clinical efficacy and safety of fluticasone propionate 250 microg twice daily administered via a HFA 134a pressurized metered dose inhaler to patients with mild to moderate asthma. French study group Respir Med 94 Suppl. B 2000 S29-S34
17. I.S. Farmer M. Middle J. Savic et al. Therapeutic equivalence of inhaled beclomethasone dipropionate with CFC and non-CFC (HFA 134a) propellants both delivered via the Easibreathe inhaler for the treatment of paediatric asthma Respir Med 94 2000 57-63
18. I.D. Peyron I.L. Britto L.B. Benissan et al. Development and performance of a new hydrofluroalkane (HFA 134a)-based metered dose inhaler (MDI) of salmeterol Resp Med 99 2005 S20-S30
19. H.D.C. Smyth The influence of formulation variables on the performance of alternative propellant-driven metered dose inhalers Adv Drug Deliv Rev 55 2003 807-828
20. M. Cazzola R. Testi M.G. Matera Clinical pharmacokinetics of salmeterol Clin Pharmacokinet 41 2002 19-30
21. N. Chopra M. Williams M. Rimmer L. Kahl M. Jenkins On behalf of the SMO30006 and SMO30007 international study teams. Salmeterol HFA is as effective as salmeterol CFC in children and adults with persistent asthma Resp Med 99 2005 S1-S10
22. Jones AE, Callejas S, Sadra P, Joyce K, Pereira A, Biddlecombe RA, Pleasance S. The determination of drugs for the treatment of asthma in plasma by automated solid phase extraction and LC-MS-MS. In: Proceedings of the 45th ASMS conference on mass spectrometry and allied topics. Palm Springs, June 1-5, 1997. p. 560
23. S.M. Kirby J. Smith G.P. Ventresca Salmeterol inhaler using a non-chlorinated propellant, HFA134a: Systemic pharmacodynamic activity in healthy volunteers Thorax 50 1995 679-681
24. J.G. Maconochie J.K. Forster Dose-response study with high-dose inhaled salmeterol in healthy subjects Br J Clin Pharmac 33 1992 342-345
25. G.R. Manchee A. Barrow S. Kulkarni et al. Disposition of salmeterol xinafoate in laboratory animals and humans Drug Metab Dispos 21 1993 1022-1028
26. J.W. Ramsdell G.L. Colice B.P. Ekholm et al. Cumulative dose response study comparing HFA-134a albuterol sulphate with conventional CFC albuterol in patients with asthma Ann Allergy Asthma Immunol 81 1998 593-599
27. R. Kunka S. Andrews M. Pimazzoni et al. Dose proportionality of fluticasone propionate from hydrofluoroalkane pressurized metered dose inhalers (pMDIs) and comparability with chlorofluorocarbon pMDIs Repir Med 94 Suppl. B 2000 S10-S16
28. C.M. Houghton S.J. Langley S.D. Singh et al. Comparison of bronchoprotective and bronchodilator effects of single dose formoterol delivered by hydrofluoroalkane and chlorofluorocarbon aerosols and dry powder in a double blind placebo-controlled study Br J Clin Pharmacol 58 2004 359-366
29. B.J. Lipworth C.M. Jackson Pharmacokinetics of chlorofluorocarbon and hydrofluoroalkane metered-dose inhaler formulations of beclomethasone dipropionate Br J Clin Pharmacol 48 1999 866-868
30. C.L. Leach P.J. Davidson B.E. Hasselquist et al. Lung deposition of hydrofluoroalkane-134a beclomethasone is greater than that of chlorofluorocarbon fluticasone and chlorofluorocarbon beclomethasone: A crossover study in healthy volunteers Chest 122 2002 510-516
31. J.A. Vanden Burgt W.W. Busse R.J. Martin et al. Efficacy and safety overview of a new inhaled corticosteroid, QVAR (hydrofluoroalkane-beclomethasone extrafine inhlation aerosol), in asthma J Allergy Clin Immunol 106 2000 1209-1226