Dose-Response of Salmeterol in Children

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To examine whether a breathing test (methacholine challenge using impulse oscillometry) can be used to tell the difference between two different doses of an inhaled drug, salmeterol, delivered by Advair in children with asthma

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Albuterol; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Methacholine Chloride; Salmeterol Xinafoate; Xhance

Criteria

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