Dose-Response of Salmeterol in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      During the study the subject will have to attend 4 study visits: 2 screening visits and 2
      treatment visits.

      Before each study visit, the subject has to stop using certain asthma medications.

      At Screening Visit 1a, the parent/guardian will read and sign the informed consent form to
      allow the subject to take part in this study. The subject, if appropriate, will be asked to
      sign the last page to indicate his/her assent to be in the study.

      The study coordinator will conduct an interview to find out about the subject's medical
      history, diseases other than asthma, previous medication and any medication that the subject
      will take during his/her participation in this study. Vital signs, i.e. blood pressure, heart
      rate, and respiration, and height and weight will be measured, and an electrocardiogram (ECG)
      which is a test to measure the electrical activity of the subject's heart, will be performed.
      The subject will be examined by a Pediatric Pulmonary physician and will be taught the proper
      way to use a Diskus® inhaler. The subject has to be able to show that he/she can do this
      correctly.

      At Screening Visit 1b, if all of the tests are in the appropriate range the subject will take
      2 puffs of Flovent from a Diskus®. One hour later, the subject will perform a breathing test
      called impulse oscillometry. Essentially, a sound is sent down into the lungs and a computer
      converts the return sound into a number. Then the subject will begin a breathing test with
      methacholine, a drug that makes the airways smaller. He/she will begin by inhaling a low dose
      in a nebulizer and then performing oscillometry. After a 5 minute interval he/she will
      breathe in increasing doses, up to 6 times or until his/her breathing test increases by 40%.
      Albuterol will be administered immediately after the end of the challenge and the subject
      will be monitored until his/her breathing returns to within 20% of where it was before the
      challenge.

      If the methacholine test results are within the appropriate range the subject will be
      eligible for the treatment phase and will be scheduled for Visit No. 2.

      At each treatment visit, the subject will take 2 puffs of study drug from two Diskus®
      inhalers, either 1 puff of Flovent and 1 puff of Advair, or 1 puff of Advair from two
      different inhalers. This is done in a blinded manner so the study coordinator does not know
      which treatment is used each time. There will be a 1 hour wait time after the medication is
      administered before the methacholine challenge is started. Albuterol will be administered
      immediately after the end of the challenge and the subject will be monitored until his/her
      breathing returns to within 20% of where it was before the challenge.
    

Intervention name(s): Advair Diskus100/50 µg; Flovent Diskus 100 µg; Methacholine Chloride; Albuterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): fluticasone; salmeterol; fluticasone
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: oscillometry; asthma; methacholine