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Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial.
Curr Med Res Opin 2006; 22(6):1217-26CM

Abstract

OBJECTIVE

To evaluate the efficacy and safety of levalbuterol metered dose inhaler (MDI) in children aged 4-11 years (n = 173).

RESEARCH DESIGN AND METHODS

Multicenter, randomized, double-blind 28-day study of QID levalbuterol 90 microg, racemic albuterol 180 mug, and placebo (2:1:1 ratio). Serial spirometry was performed on Days 0, 14, and 28. The primary endpoint was the double-blind average peak percent (%) change in FEV(1) from visit pre-dose; the primary comparison was with placebo. Secondary endpoints included the area under the FEV(1) percent change from pre-dose curve and peak % predicted FEV(1). Safety endpoints included adverse events, laboratory tests, rescue medication use, and electrocardiograms.

RESULTS

Levalbuterol significantly improved the least square mean peak percent change in FEV(1) compared with placebo (levalbuterol 25.6% +/- 1.3% [p < 0.001]; racemic albuterol 21.8% +/- 1.8% [p = ns]; placebo 16.8% +/- 1.9%). Results for levalbuterol were similar for the other spirometry endpoints (p < 0.05 vs. placebo). No levalbuterol-treated patients had a peak percent change in FEV(1) < 10% (compared with 15.8% of racemic albuterol-treated patients and 30.3% of placebo-treated patients). The incidence of adverse events was 43.4% for levalbuterol, 56.4% for racemic albuterol, and 51.4% for placebo. The rate of discontinuation was 1.3% for levalbuterol, 2.6% for racemic albuterol, and 8.6% for placebo. The rate of asthma attacks (10.5%, 12.8%, 14.3%, respectively) was similar among treatments. Levalbuterol and racemic albuterol both reduced rescue medication use (p < 0.01 vs. placebo) and produced changes in ventricular heart rate and QT(c-F) that were similar to placebo.

CONCLUSIONS

In this study, levalbuterol administered via MDI significantly improved airway function in comparison with placebo in asthmatic children aged 4-11 years with a safety profile that was similar to placebo.

Authors+Show Affiliations

Allergy and Asthma Associates of Southern California, Mission Viejo, CA, USA.No 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16846555

Citation

Berger, William E., et al. "Evaluation of Levalbuterol Metered Dose Inhaler in Pediatric Patients With Asthma: a Double-blind, Randomized, Placebo- and Active-controlled Trial." Current Medical Research and Opinion, vol. 22, no. 6, 2006, pp. 1217-26.
Berger WE, Milgrom H, Skoner DP, et al. Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial. Curr Med Res Opin. 2006;22(6):1217-26.
Berger, W. E., Milgrom, H., Skoner, D. P., Tripp, K., Parsey, M. V., & Baumgartner, R. A. (2006). Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial. Current Medical Research and Opinion, 22(6), pp. 1217-26.
Berger WE, et al. Evaluation of Levalbuterol Metered Dose Inhaler in Pediatric Patients With Asthma: a Double-blind, Randomized, Placebo- and Active-controlled Trial. Curr Med Res Opin. 2006;22(6):1217-26. PubMed PMID: 16846555.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial. AU - Berger,William E, AU - Milgrom,Henry, AU - Skoner,David P, AU - Tripp,Kenneth, AU - Parsey,Merdad V, AU - Baumgartner,Rudolf A, AU - ,, PY - 2006/7/19/pubmed PY - 2006/11/3/medline PY - 2006/7/19/entrez SP - 1217 EP - 26 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 6 N2 - OBJECTIVE: To evaluate the efficacy and safety of levalbuterol metered dose inhaler (MDI) in children aged 4-11 years (n = 173). RESEARCH DESIGN AND METHODS: Multicenter, randomized, double-blind 28-day study of QID levalbuterol 90 microg, racemic albuterol 180 mug, and placebo (2:1:1 ratio). Serial spirometry was performed on Days 0, 14, and 28. The primary endpoint was the double-blind average peak percent (%) change in FEV(1) from visit pre-dose; the primary comparison was with placebo. Secondary endpoints included the area under the FEV(1) percent change from pre-dose curve and peak % predicted FEV(1). Safety endpoints included adverse events, laboratory tests, rescue medication use, and electrocardiograms. RESULTS: Levalbuterol significantly improved the least square mean peak percent change in FEV(1) compared with placebo (levalbuterol 25.6% +/- 1.3% [p < 0.001]; racemic albuterol 21.8% +/- 1.8% [p = ns]; placebo 16.8% +/- 1.9%). Results for levalbuterol were similar for the other spirometry endpoints (p < 0.05 vs. placebo). No levalbuterol-treated patients had a peak percent change in FEV(1) < 10% (compared with 15.8% of racemic albuterol-treated patients and 30.3% of placebo-treated patients). The incidence of adverse events was 43.4% for levalbuterol, 56.4% for racemic albuterol, and 51.4% for placebo. The rate of discontinuation was 1.3% for levalbuterol, 2.6% for racemic albuterol, and 8.6% for placebo. The rate of asthma attacks (10.5%, 12.8%, 14.3%, respectively) was similar among treatments. Levalbuterol and racemic albuterol both reduced rescue medication use (p < 0.01 vs. placebo) and produced changes in ventricular heart rate and QT(c-F) that were similar to placebo. CONCLUSIONS: In this study, levalbuterol administered via MDI significantly improved airway function in comparison with placebo in asthmatic children aged 4-11 years with a safety profile that was similar to placebo. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/16846555/Evaluation_of_levalbuterol_metered_dose_inhaler_in_pediatric_patients_with_asthma:_a_double_blind_randomized_placebo__and_active_controlled_trial_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079906X112534 DB - PRIME DP - Unbound Medicine ER -