Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma☆,☆☆,★,★★
Section snippets
Subjects
Four hundred twenty-four patients at 33 outpatient asthma clinics in the United States (see Appendix) were enrolled in the study. Eligible patients were nonsmoking males or females 12 years of age or older who had at least a 6-month history of chronic and stable asthma (as defined by the American Thoracic Society) requiring pharmacotherapy. Patients were eligible if they had moderate-to-severe lung compromise, defined as an FEV1 between 45% and 70% of predicted normal value for age, gender,
Demographics and disposition
A total of 424 patients enrolled in the study. Sixty-two patients were withdrawn before randomization, 35 (56.5%) of whom did not meet enrollment criteria. Twelve patients (19.4%) voluntarily withdrew, 9 patients (14.5%) were withdrawn because of adverse events (including asthma exacerbation), and 6 patients (9.6%) were lost to follow-up or withdrew for other causes. Of the 362 patients who were randomized into the double-blind treatment period, 328 (90.6%) completed the study and 34 were
DISCUSSION
The effects of the (R)-enantiomer of albuterol, levalbuterol HCl, were compared with those of placebo and standard racemic albuterol in adolescent and adult patients with moderate-to-severe asthma. The study was powered to determine differences between active treatments compared with placebo and was not designed to detect intertreatment differences. Although all of the active treatment arms experienced significant improvement in their FEV1 values compared with placebo, the levalbuterol doses
References (34)
New guidelines for diagnosis and management of asthma
Ann Allergy
(1997)- et al.
Ketotifen inhibits exacerbation of allergic airway hyperreactivity by racemic salbutamol in the guinea pig
J Allergy Clin Immunol
(1993) - et al.
Exacerbation of airway hyperreactivity by (±) salbutamol in sensitized guinea pigs
Jpn J Pharmacol
(1993) - et al.
Regular inhaled beta-agonist treatment in bronchial asthma
Lancet
(1990) - et al.
Regular use of inhaled albuterol and the allergen-induced late asthmatic response
J Allergy Clin Immunol
(1995) - et al.
Regular inhaled salbutamol and airway responsiveness to allergen
Lancet
(1993) - et al.
A twelve week comparison of salmeterol and salbutamol in the treatment of mild-to-moderate asthma: a Canadian multi-center study
J Allergy Clin Immunol
(1997) - et al.
Assessment of tachyphylaxis following prolonged therapy of asthma with inhaled albuterol aerosol
Chest
(1984) ß-Adrenergic bronchodilators
N Engl J Med
(1995)- et al.
Comparison or R-, S-, and RS-albuterol interaction with human ß1- and ß2-adrenergic receptors
Clin Rev Allergy Immunol
(1996)
Albuterol
Clin Rev Allergy Immunol
Absolute configuration of the optical isomers of salbutamol
J Med Chem
FDA’s Policy Statement for the development of new stereoisomeric drugs
Chirality
S-albuterol exacerbates calcium responses to carbachol in airway smooth muscle cells
Clin Rev Allergy Immunol
(S)-albuterol increases intracellular free calcium by muscarinic receptor activation and a phospholipase C-dependent mechanism in airway smooth muscle
Mol Pharmacol
Anomalous effects of albuterol and other sympathomimetics in the guinea pig
Clin Rev Allergy Immunol
Effects of albuterol enantiomers on in vitro bronchial reactivity
Clin Rev Allergy Immunol
Cited by (169)
Childhood asthma. A guide for pediatric emergency medicine providers
2013, Emergency Medicine Clinics of North AmericaAirway Pharmacology
2013, Benumof and Hagberg's Airway ManagementAirway Pharmacology
2012, Benumof and Hagberg's Airway Management: Third EditionCommon Pediatric Respiratory Emergencies
2012, Emergency Medicine Clinics of North AmericaHigh-Dose Continuous Nebulized Levalbuterol for Pediatric Status Asthmaticus: A Randomized Trial
2009, Journal of Pediatrics
- ☆
From a the National Jewish Medical and Research Center, Denver; b Allergy, Immunology & Asthma Group, Inc, Stockton; c 317 North El Camino Real, Encinitas; d PPD Pharmaco Inc, Wilmington; and e Sepracor Inc, Marlborough.
- ☆☆
Supported by a grant from Sepracor Inc, Marlborough, Mass.
- ★
Reprint requests: Harold S. Nelson, MD, National Jewish Medical and Research Center, 1400 Jackson St, Denver, CO 80206.
- ★★
0091-6749/98 $5.00 + 0 1/1/94588