Dose-Response of Salmeterol in Children

Inclusion Criteria

• parent/legal guardian and subject must be able to speak and understand English and patient must be willing and able to give assent to take part in the study
• diagnosed with asthma for at least 6 months
• able to demonstrate inhalation technique with study device
• if taking inhaled corticosteroids, dose must be stable for 2 weeks
• no significant concomitant medical conditions or abnormal physical findings on screening except for those consistent with asthma and allergic rhinitis
• airway responsiveness to methacholine with a baseline provocational dose causing an increase of at least 40% in R5 (PC40R5) at no more than 8 mg/mL

Exclusion Criteria

• female who has started menstruating
• past or present history of any allergic reaction to any of the medications or formulations administered in this study
• prior treatment with systemic corticosteroids in last 30 days or more than 4 courses in previous 12 months
• use of short-acting beta-agonist more than two times per week in the previous month
• use of long-acting beta-agonist in the 3 weeks before the first methacholine challenge or during the study
• change in dosage of inhaled corticosteroids in previous 30 days, nasal steroids in previous 15 days and montelukast in last 7 days
• history of life-threatening asthma, including loss of consciousness, intubation and/or admission to ICU
• hospitalization for acute asthma within past year
• inability to withhold the following medications before methacholine challenges:
• short-acting beta-agonists at least 6 hours
• regular long-acting beta-agonists at least 3 weeks
• inhaled corticosteroid at least 2 hours
• montelukast at least 24 hours
• aspirin and non-steroid anti-inflammatory drugs at least 48 hours
• caffeine at least 4 hours