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This open-label, placebo-controlled study was undertaken to assess the safety and effectiveness of bitolterol mesylate in pediatric asthma patients. Bitolterol mesylate was administered in increasing doses of 0.5 to 3.5 mg by continuous-flow nebulization on separate days to children 4 to 12 years of age. Pulmonary function tests and vital signs were measured before and for up to eight hours after each treatment. Bronchodilation was defined as a > or = 15% increase in FEV1 over baseline. Onset, magnitude, and duration of bronchodilation all showed general dose-related improvements. Onset of bronchodilation occurred within five minutes in 66% to 82% of all treatments. The mean maximum percent increase in FEV1 ranged from 35% to 52% for all doses. Median durations of bronchodilation in responding patients ranged from four and one tenth to more than eight hours. Bitolterol was well-tolerated with all adverse effects being mild to moderate in severity and transient in nature. Although the incidence of cough, increased pulse rate, and tremor were relatively low, they did increase slightly with the 2.5- and 3.5-mg doses. No significant clinical laboratory or electrocardiographic findings were noted. We conclude that doses of 1.0 and 1.5 mg bitolterol mesylate administered by continuous-flow nebulization are safe, effective, and well-tolerated for the treatment of asthma in pediatric patients.
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
April 1987,
Chest,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
January 1996,
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
January 1986,
The Journal of allergy and clinical immunology,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
March 1986,
The Journal of allergy and clinical immunology,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
January 1984,
The Journal of allergy and clinical immunology,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
June 1986,
Annals of allergy,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
July 2020,
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
January 1997,
Revue de pneumologie clinique,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
July 1987,
Annals of allergy,
R A Nathan, and
E A Bronsky, and
R J Dockhorn, and
J P Kemp
June 1987,
American journal of hospital pharmacy,
