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Evaluation of the safety and efficacy of levalbuterol in 2-5-year-old patients with asthma.
Pediatr Pulmonol. 2005 Dec; 40(6):477-86.PP

Abstract

The purpose of this study was to evaluate the safety and efficacy of single-isomer (R)-albuterol (levalbuterol, LEV) in children aged 2-5 years. Children aged 2-5 years (n = 211) participated in this multicenter, randomized, double-blind study of 21 days of t.i.d. LEV (0.31 mg or 0.63 mg without regard to weight), racemic albuterol (RAC, 1.25 mg for children <33 pounds (lb); 2.5 mg for children >/=33 lb), or placebo (PBO). Endpoints included adverse-event (AE) reporting, safety parameters, peak expiratory flow (PEF), the Pediatric Asthma Questionnaire(c) (PAQ), and the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). Baseline disease severity was generally mild in all groups, as defined by PAQ scores that ranged from 6.3-7.3 on a scale of 0-27 and 1.5 days/week of uncontrolled asthma. After treatment, the PAQ decreased in all groups (P = NS). In the subset of subjects able to perform PEF (51.7%), all active treatments improved in-clinic PEF after the first dose (mean +/- SD: PBO, 1.4 +/- 20.8; LEV 0.31 mg, 12.4 +/- 12; LEV 0.63 mg, 16.7 +/- 15.4; RAC, 18.0 +/- 16.5 l/min; P < 0.01). PACQLQ measurements improved more than the minimally important difference only in the LEV-treated groups, and were significant in children <33 lb (P < 0.05). Asthma exacerbations occurred primarily in children >/=33 lb, and one serious asthma exacerbation occurred in the 2.5-mg RAC group. RAC and LEV 0.63 mg, but not LEV 0.31 mg or placebo, led to significant increases in ventricular heart rate. In this study of levalbuterol in children aged 2-5 years with asthma, LEV was generally well-tolerated, and in children able to perform PEF, led to significant bronchodilation compared with placebo.

Authors+Show Affiliations

Allegheny General Hospital, Division of Allergy, Asthma and Immunology, Pittsburgh, Pennsylvania, USA.No 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

16193496

Citation

Skoner, David P., et al. "Evaluation of the Safety and Efficacy of Levalbuterol in 2-5-year-old Patients With Asthma." Pediatric Pulmonology, vol. 40, no. 6, 2005, pp. 477-86.
Skoner DP, Greos LS, Kim KT, et al. Evaluation of the safety and efficacy of levalbuterol in 2-5-year-old patients with asthma. Pediatr Pulmonol. 2005;40(6):477-86.
Skoner, D. P., Greos, L. S., Kim, K. T., Roach, J. M., Parsey, M., & Baumgartner, R. A. (2005). Evaluation of the safety and efficacy of levalbuterol in 2-5-year-old patients with asthma. Pediatric Pulmonology, 40(6), 477-86.
Skoner DP, et al. Evaluation of the Safety and Efficacy of Levalbuterol in 2-5-year-old Patients With Asthma. Pediatr Pulmonol. 2005;40(6):477-86. PubMed PMID: 16193496.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the safety and efficacy of levalbuterol in 2-5-year-old patients with asthma. AU - Skoner,David P, AU - Greos,Leon S, AU - Kim,Kenneth T, AU - Roach,James M, AU - Parsey,Merdad, AU - Baumgartner,Rudolf A, PY - 2005/9/30/pubmed PY - 2006/3/24/medline PY - 2005/9/30/entrez SP - 477 EP - 86 JF - Pediatric pulmonology JO - Pediatr. Pulmonol. VL - 40 IS - 6 N2 - The purpose of this study was to evaluate the safety and efficacy of single-isomer (R)-albuterol (levalbuterol, LEV) in children aged 2-5 years. Children aged 2-5 years (n = 211) participated in this multicenter, randomized, double-blind study of 21 days of t.i.d. LEV (0.31 mg or 0.63 mg without regard to weight), racemic albuterol (RAC, 1.25 mg for children <33 pounds (lb); 2.5 mg for children >/=33 lb), or placebo (PBO). Endpoints included adverse-event (AE) reporting, safety parameters, peak expiratory flow (PEF), the Pediatric Asthma Questionnaire(c) (PAQ), and the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). Baseline disease severity was generally mild in all groups, as defined by PAQ scores that ranged from 6.3-7.3 on a scale of 0-27 and 1.5 days/week of uncontrolled asthma. After treatment, the PAQ decreased in all groups (P = NS). In the subset of subjects able to perform PEF (51.7%), all active treatments improved in-clinic PEF after the first dose (mean +/- SD: PBO, 1.4 +/- 20.8; LEV 0.31 mg, 12.4 +/- 12; LEV 0.63 mg, 16.7 +/- 15.4; RAC, 18.0 +/- 16.5 l/min; P < 0.01). PACQLQ measurements improved more than the minimally important difference only in the LEV-treated groups, and were significant in children <33 lb (P < 0.05). Asthma exacerbations occurred primarily in children >/=33 lb, and one serious asthma exacerbation occurred in the 2.5-mg RAC group. RAC and LEV 0.63 mg, but not LEV 0.31 mg or placebo, led to significant increases in ventricular heart rate. In this study of levalbuterol in children aged 2-5 years with asthma, LEV was generally well-tolerated, and in children able to perform PEF, led to significant bronchodilation compared with placebo. SN - 8755-6863 UR - https://www.unboundmedicine.com/medline/citation/16193496/Evaluation_of_the_safety_and_efficacy_of_levalbuterol_in_2_5_year_old_patients_with_asthma_ L2 - https://doi.org/10.1002/ppul.20288 DB - PRIME DP - Unbound Medicine ER -