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A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects.
J Allergy Clin Immunol 2008; 122(3):544-9JA

Abstract

BACKGROUND

The short-acting beta(2)-agonists levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI).

OBJECTIVE

This study compared the short-term safety and efficacy of cumulative doses of levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects.

METHODS

This was a randomized, modified-blind, active-controlled, multicenter, 2-way crossover study. Subjects (n = 49) were randomized to 16 cumulative doses (1x, 2x, 4x, 8x, and 16x) of levalbuterol (45 microg per dose) or racemic albuterol (90 microg per dose) administered over a 2-hour period. After a 7-day washout period, subjects were crossed over to the other treatment. After each dose, safety outcomes and pulmonary function were assessed.

RESULTS

Heart rate and (R)-albuterol exposure increased for both racemic albuterol HFA and levalbuterol HFA. For cumulative doses of 8x or greater, racemic albuterol HFA treatment had greater increases in mean heart rate than levalbuterol HFA (least-squares mean [+/- SD] difference at the 8x dose was 2.8 beats/min [95% CI, 0.3-5.3] and at the 16x dose was 3.5 beats/min [95% CI, 0.6-6.4]). (R)-albuterol plasma levels ranged from 10% to 18% higher after racemic albuterol HFA MDI dosing versus after levalbuterol HFA MDI. FEV(1) improvements were similar for both treatments. The relative potencies of the 2 therapies, based on FEV(1), were similar (ratio, 1.1 [90% CI, 0.9-1.2]; Finney method).

CONCLUSION

In this study single-day cumulative dosing of asthmatic subjects with levalbuterol HFA MDI or racemic albuterol HFA MDI resulted in similar improvements in FEV(1) and tolerability. Plasma (R)-albuterol levels and mean heart rate were less with levalbuterol HFA MDI.

Authors+Show Affiliations

Sepracor, Inc, Marlborough, MA 01752, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18692886

Citation

Tripp, Kenneth, et al. "A Cumulative Dose Study of Levalbuterol and Racemic Albuterol Administered By Hydrofluoroalkane-134a Metered-dose Inhaler in Asthmatic Subjects." The Journal of Allergy and Clinical Immunology, vol. 122, no. 3, 2008, pp. 544-9.
Tripp K, McVicar WK, Nair P, et al. A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects. J Allergy Clin Immunol. 2008;122(3):544-9.
Tripp, K., McVicar, W. K., Nair, P., Corren, J., Pleskow, W. W., Goodwin, E., ... Hanrahan, J. P. (2008). A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects. The Journal of Allergy and Clinical Immunology, 122(3), pp. 544-9. doi:10.1016/j.jaci.2008.06.015.
Tripp K, et al. A Cumulative Dose Study of Levalbuterol and Racemic Albuterol Administered By Hydrofluoroalkane-134a Metered-dose Inhaler in Asthmatic Subjects. J Allergy Clin Immunol. 2008;122(3):544-9. PubMed PMID: 18692886.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects. AU - Tripp,Kenneth, AU - McVicar,William K, AU - Nair,Parameswaran, AU - Corren,Jonathan, AU - Pleskow,Warren W, AU - Goodwin,Elizabeth, AU - Baumgartner,Rudolf A, AU - Hanrahan,John P, Y1 - 2008/08/09/ PY - 2008/02/07/received PY - 2008/05/16/revised PY - 2008/06/09/accepted PY - 2008/8/12/pubmed PY - 2008/10/2/medline PY - 2008/8/12/entrez SP - 544 EP - 9 JF - The Journal of allergy and clinical immunology JO - J. Allergy Clin. Immunol. VL - 122 IS - 3 N2 - BACKGROUND: The short-acting beta(2)-agonists levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI). OBJECTIVE: This study compared the short-term safety and efficacy of cumulative doses of levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects. METHODS: This was a randomized, modified-blind, active-controlled, multicenter, 2-way crossover study. Subjects (n = 49) were randomized to 16 cumulative doses (1x, 2x, 4x, 8x, and 16x) of levalbuterol (45 microg per dose) or racemic albuterol (90 microg per dose) administered over a 2-hour period. After a 7-day washout period, subjects were crossed over to the other treatment. After each dose, safety outcomes and pulmonary function were assessed. RESULTS: Heart rate and (R)-albuterol exposure increased for both racemic albuterol HFA and levalbuterol HFA. For cumulative doses of 8x or greater, racemic albuterol HFA treatment had greater increases in mean heart rate than levalbuterol HFA (least-squares mean [+/- SD] difference at the 8x dose was 2.8 beats/min [95% CI, 0.3-5.3] and at the 16x dose was 3.5 beats/min [95% CI, 0.6-6.4]). (R)-albuterol plasma levels ranged from 10% to 18% higher after racemic albuterol HFA MDI dosing versus after levalbuterol HFA MDI. FEV(1) improvements were similar for both treatments. The relative potencies of the 2 therapies, based on FEV(1), were similar (ratio, 1.1 [90% CI, 0.9-1.2]; Finney method). CONCLUSION: In this study single-day cumulative dosing of asthmatic subjects with levalbuterol HFA MDI or racemic albuterol HFA MDI resulted in similar improvements in FEV(1) and tolerability. Plasma (R)-albuterol levels and mean heart rate were less with levalbuterol HFA MDI. SN - 1097-6825 UR - https://www.unboundmedicine.com/medline/citation/18692886/A_cumulative_dose_study_of_levalbuterol_and_racemic_albuterol_administered_by_hydrofluoroalkane_134a_metered_dose_inhaler_in_asthmatic_subjects_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0091-6749(08)01136-6 DB - PRIME DP - Unbound Medicine ER -