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Low-dose levalbuterol in children with asthma: safety and efficacy in comparison with placebo and racemic albuterol.
J Allergy Clin Immunol. 2001 Dec; 108(6):938-45.JA

Abstract

BACKGROUND

Racemic albuterol (RAC) is an equal mixture of (R)-albuterol and (S)-albuterol. Only the (R)-isomer, levalbuterol (LEV), is therapeutically active. Lower doses of LEV, devoid of (S)-albuterol, have demonstrated efficacy comparable to that of higher doses of the (R)-isomer administered as a component of RAC.

OBJECTIVE

The purpose of this study was to determine whether LEV results in improved safety and efficacy in children.

METHODS

Asthmatic children aged 4 to 11 years (n = 338; FEV(1), 40% to 85% of predicted) participated in this multicenter, randomized, double-blinded study and received 21 days of 3-times-a-day treatment with nebulized LEV (0.31 or 0.63 mg), RAC (1.25 or 2.5 mg), or placebo. The primary endpoint was FEV(1) (peak percent change). Adverse events, clinical laboratory test results, vital signs, and electrocardiograms were evaluated for safety.

RESULTS

All active treatments significantly improved the primary endpoint in comparison with placebo (P < .001). Significant differences in FEV(1) were noted immediately after nebulization (median change, 2.0%, 19.0%, 18.1%, 12.4%, and 15.6% for placebo, LEV 0.31 and 0.63, RAC 1.25 and 2.5 mg, respectively; P < .05 vs placebo; P < .05 for LEV 0.31 and 0.63 vs RAC 1.25 mg). LEV 0.31 mg was the only treatment not different from placebo for changes in ventricular heart rate, QT(c) interval, and glucose (P > .05). All active treatments decreased serum potassium (range, -0.3 to -0.6; P < .002 vs placebo), and RAC 2.5 mg caused the greatest change (P < .005 vs other actives). In a patient subset with severe asthma, a dose-response relationship was observed for levalbuterol, indicating that higher doses were more effective.

CONCLUSION

LEV was clinically comparable to 4- to 8-fold higher doses of RAC, and it demonstrated a more favorable safety profile. LEV 0.31 mg should be used as the starting dose in 4-11 year old children with mild to moderate persistent asthma. Patients with severe disease might benefit from higher doses.

Authors+Show Affiliations

National Jewish Medical and Research Center, Denver, Colorado, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11742271

Citation

Milgrom, H, et al. "Low-dose Levalbuterol in Children With Asthma: Safety and Efficacy in Comparison With Placebo and Racemic Albuterol." The Journal of Allergy and Clinical Immunology, vol. 108, no. 6, 2001, pp. 938-45.
Milgrom H, Skoner DP, Bensch G, et al. Low-dose levalbuterol in children with asthma: safety and efficacy in comparison with placebo and racemic albuterol. J Allergy Clin Immunol. 2001;108(6):938-45.
Milgrom, H., Skoner, D. P., Bensch, G., Kim, K. T., Claus, R., & Baumgartner, R. A. (2001). Low-dose levalbuterol in children with asthma: safety and efficacy in comparison with placebo and racemic albuterol. The Journal of Allergy and Clinical Immunology, 108(6), 938-45.
Milgrom H, et al. Low-dose Levalbuterol in Children With Asthma: Safety and Efficacy in Comparison With Placebo and Racemic Albuterol. J Allergy Clin Immunol. 2001;108(6):938-45. PubMed PMID: 11742271.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose levalbuterol in children with asthma: safety and efficacy in comparison with placebo and racemic albuterol. AU - Milgrom,H, AU - Skoner,D P, AU - Bensch,G, AU - Kim,K T, AU - Claus,R, AU - Baumgartner,R A, AU - ,, PY - 2001/12/14/pubmed PY - 2002/1/23/medline PY - 2001/12/14/entrez SP - 938 EP - 45 JF - The Journal of allergy and clinical immunology JO - J. Allergy Clin. Immunol. VL - 108 IS - 6 N2 - BACKGROUND: Racemic albuterol (RAC) is an equal mixture of (R)-albuterol and (S)-albuterol. Only the (R)-isomer, levalbuterol (LEV), is therapeutically active. Lower doses of LEV, devoid of (S)-albuterol, have demonstrated efficacy comparable to that of higher doses of the (R)-isomer administered as a component of RAC. OBJECTIVE: The purpose of this study was to determine whether LEV results in improved safety and efficacy in children. METHODS: Asthmatic children aged 4 to 11 years (n = 338; FEV(1), 40% to 85% of predicted) participated in this multicenter, randomized, double-blinded study and received 21 days of 3-times-a-day treatment with nebulized LEV (0.31 or 0.63 mg), RAC (1.25 or 2.5 mg), or placebo. The primary endpoint was FEV(1) (peak percent change). Adverse events, clinical laboratory test results, vital signs, and electrocardiograms were evaluated for safety. RESULTS: All active treatments significantly improved the primary endpoint in comparison with placebo (P < .001). Significant differences in FEV(1) were noted immediately after nebulization (median change, 2.0%, 19.0%, 18.1%, 12.4%, and 15.6% for placebo, LEV 0.31 and 0.63, RAC 1.25 and 2.5 mg, respectively; P < .05 vs placebo; P < .05 for LEV 0.31 and 0.63 vs RAC 1.25 mg). LEV 0.31 mg was the only treatment not different from placebo for changes in ventricular heart rate, QT(c) interval, and glucose (P > .05). All active treatments decreased serum potassium (range, -0.3 to -0.6; P < .002 vs placebo), and RAC 2.5 mg caused the greatest change (P < .005 vs other actives). In a patient subset with severe asthma, a dose-response relationship was observed for levalbuterol, indicating that higher doses were more effective. CONCLUSION: LEV was clinically comparable to 4- to 8-fold higher doses of RAC, and it demonstrated a more favorable safety profile. LEV 0.31 mg should be used as the starting dose in 4-11 year old children with mild to moderate persistent asthma. Patients with severe disease might benefit from higher doses. SN - 0091-6749 UR - https://www.unboundmedicine.com/medline/citation/11742271/Low_dose_levalbuterol_in_children_with_asthma:_safety_and_efficacy_in_comparison_with_placebo_and_racemic_albuterol_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0091-6749(01)37216-0 DB - PRIME DP - Unbound Medicine ER -