Dose-Response of Salmeterol in Children
Condition: Asthma
MeSH terms: Asthma
Intervention: Advair Diskus100/50 µg; Flovent Diskus 100 µg; Methacholine Chloride; Albuterol
Intervention description: Advair Diskus 100/50 µg; Flovent Diskus 100 µg; Methacholine Chloride in quadrupling concentrations from 0.25 to 64 mg/mL will be given based upon subject's baseline response.; Albuterol will be administered at the end of each methacholine challenge.
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Methacholine Chloride
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: oscillometry; asthma; methacholine

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
    

Eligibility 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