This data has not been previously presented.
1099-0496/asset/PPUL_left.gif?v=1&s=e8619a3cee0d6c89bf229cccb87c45f4fc06ef2f)
1099-0496/asset/PPUL_centre.gif?v=1&s=50c62acecf2eca9b4984459eb3e50e4cd8914b61)
Original Articles
A cumulative dose, safety and tolerability study of arformoterol in pediatric subjects with stable asthma†‡
Article first published online: 16 MAY 2011
DOI: 10.1002/ppul.21446
Copyright © 2011 Wiley-Liss, Inc.
Additional Information
How to Cite
Hinkle, J., Hinson, J., Kerwin, E., Goodwin, E., Sciarappa, K., Curry, L. and Hanrahan, J.P. (2011), A cumulative dose, safety and tolerability study of arformoterol in pediatric subjects with stable asthma. Pediatr. Pulmonol., 46: 761–769. doi: 10.1002/ppul.21446
- †
- ‡
Joseph Hinkle MD is an employee of Sunovion Pharmaceuticals Inc. James M Hinson, Jr MD is a principal in Unicorn Pharma Consulting of Brentwood, LLC. Edward Kerwin MD has served on speakers panels or advisory boards for Astra Zeneca, Dey Laboratories, GlaxoSmithKline, Merck, Pfizer, Sanofi Aventis, Schering Plough, Teva Labs, and UCB Pharma. He has conducted clinical research trials for forty pharmaceutical companies including Sunovion Pharmaceuticals. Elizabeth Goodwin PhD is a former employee of Sunovion Pharmaceuticals Inc. Ken Sciarappa PhD is an employee of Sunovion Pharmaceuticals Inc. Lisa Curry BS is an employee of Sunovion Pharmaceuticals Inc. John Hanrahan is a full-time employee of Pulmatrix, Inc. and a former employee of Sunovion Pharmaceuticals Inc.
Publication History
- Issue published online: 12 JUL 2011
- Article first published online: 16 MAY 2011
- Manuscript Accepted: 3 FEB 2011
- Manuscript Revised: 24 JAN 2011
- Manuscript Received: 14 JUN 2010
Funded by
- Sunovion Pharmaceuticals Inc.
- Abstract
- Article
- References
- Cited By
Keywords:
- asthma;
- pediatrics;
- long-acting β2-agonist;
- arformoterol;
- levalbuterol;
- safety
Abstract
Purpose
Short-acting β2-agonists (SABAs) are recommended for treating acute pediatric asthma. The long-acting β2-agonist (LABA) arformoterol is approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Arformoterol acts rapidly, is delivered via nebulization, and, as such, raises concerns from the FDA over possible off-label use in acute asthma in children. As a step to investigate this issue, this study evaluated the safety and tolerability of three consecutive doses of arformoterol administered over 1 hr in children with stable asthma.
Methods
This study consisted of a double-blind, crossover period in which subjects (ages 2–11 years) with stable asthma were randomized to three consecutive nebulized doses of arformoterol (7.5 µg/dose) or levalbuterol (0.63 mg/dose) administered over 1-hr (0, 30, and 60 min) followed by an open-label period with three consecutive doses of arformoterol (15 µg/dose) administered over 1 hr. Endpoints were change in heart rate, blood pressure, and serum potassium and glucose levels. Other endpoints included adverse events and pulmonary function.
Results
There were no clinically important mean changes from pre-dose in heart rate, blood pressure, or serum glucose levels, across treatment groups. Substantial declines in serum potassium levels were observed both 2 and 6 hr post-dosing. Two subjects had declines to 2.8 mEq/L and 2.9 mEq/L 2-hr post-dosing. Adverse events were infrequent and differences in forced expiratory volume in 1 sec and peak expiratory flow across treatment groups were not clinically meaningful.
Conclusion
In this study, in children with stable asthma, three consecutive doses of arformoterol (7.5 and 15 µg) and levalbuterol were overall well tolerated. Nonetheless, serum potassium levels demonstrated substantial mean declines after dosing. These findings do not address or support the safety and tolerability of arformoterol use in acute exacerbations of asthma in children. Pediatr. Pulmonol. 2011; 46:761–769. © 2011 Wiley-Liss, Inc.