Abstract | BACKGROUND: Patients with exercise-induced bronchospasm (EIB) may benefit from a prophylactic beta2-adrenergic agonist that combines rapid onset with long duration of action. OBJECTIVE: METHODS: Eighteen patients with EIB were randomized to treatment in a double-blind, placebo-controlled, four-way, crossover study. Seventeen patients completed all four crossover periods. Each patient received in random sequence a single dose of formoterol (12 or 24 microg), albuterol (180 microg), or placebo at intervals of 5 +/- 2 days. Pulmonary function measurements were taken before and after exercise challenge tests (ECTs) at 15 minutes postdosing and at 4, 8, and 12 hours postdosing. RESULTS: Both doses of formoterol produced significantly greater protection against EIB, compared with placebo, at all timepoints (P < or = 0.016). The two doses of formoterol were not significantly different from one another at any time. Protection against EIB with albuterol was clinically significant only for the 15-minute ECT and was statistically superior to placebo for the 15-minute and 4-hour ECTs. Although formoterol and albuterol exhibited a rapid onset of action, formoterol provided longer-lasting protection over the 12-hour observation period. Rescue medication was used substantially less with either dose of formoterol, compared with albuterol or placebo. All treatments were well tolerated. Two-hour postdosing electrocardiograms and vital signs were unremarkable for all study treatments. CONCLUSION: A single dose of formoterol (12 or 24 microg) provides protection against EIB within 15 minutes of dosing and persists for up to 12 hours. Formoterol is safe and well tolerated.
|
Authors | Edwin A Bronsky, Umit Yegen, Ching Ming Yeh, Lawrence V Larsen, Giovanni Della Cioppa |
Journal | Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
(Ann Allergy Asthma Immunol)
Vol. 89
Issue 4
Pg. 407-12
(Oct 2002)
ISSN: 1081-1206 [Print] United States |
PMID | 12392386
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Adrenergic beta-Agonists
- Ethanolamines
- Formoterol Fumarate
|
Topics |
- Adolescent
- Adrenergic beta-Agonists
(administration & dosage, adverse effects)
- Adult
- Asthma, Exercise-Induced
(prevention & control)
- Cross-Over Studies
- Double-Blind Method
- Ethanolamines
(administration & dosage, adverse effects)
- Female
- Forced Expiratory Volume
- Formoterol Fumarate
- Humans
- Male
- Peak Expiratory Flow Rate
|