Fall Epidemic Viral Pediatric Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel
      group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma
      exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316
      subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments
      using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment
      starting in April 2010. Eligible subjects will be invited to return for randomization into
      the study in August 2010. This exploratory study is being conducted to assess whether
      treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of
      exacerbation and the asthma impairment associated with viral respiratory tract infections
      during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.
    

Detailed description: 
      Study ADA113872 will assess the ability of ADVAIR™ DISKUS™ 100/50 mcg, in comparison to
      FLOVENT™ DISKUS™ 100 mcg, to reduce worsening asthma associated with viral respiratory
      infections during the fall season in a pediatric population. A number of descriptive measures
      will be used to assess the reduction in worsening asthma. These include the number of
      exacerbations, the duration and severity of asthma symptoms in the 7 days following the
      report of moderate upper respiratory tract symptoms or worsening asthma, the number of
      rescue-free days, and the rate of asthma control days.

      Subjects will be identified starting in April 2010 to evaluate whether they meet the
      eligibility criteria. If a subject is identified as a potential candidate for the study they
      will be requested to return to the clinic between August 2, 2010 and August 20, 2010.
      Subjects who meet all inclusion and none of the exclusion criteria will be entered into the
      study. All subjects must be randomized on or before August 20th, 2010.

      Subjects will be males and females who are between the ages of 4 and 11 years (as of
      randomization date) with a documented diagnosis of asthma requiring ICS monotherapy
      controller medication or low dose ICS as part of combination controller medication. In order
      for a subject on moderate dose ICS or low dose ICS + LABA combination therapy to be eligible
      for inclusion in this study their asthma must be under control for the 3 months prior to
      randomization and they must be a candidate for step-down therapy as outlined by current
      asthma management guidelines.

      All subjects must have a history of one or more exacerbations during the previous respiratory
      viral season that required the use of outpatient oral/parenteral corticosteroid or an urgent
      care, Emergency Department visit hospitalization, or for asthma that required the use of
      oral/parenteral corticosteroid.

      Subjects will receive their study medication at the Randomization visit and be instructed to
      keep an electronic daily record of AM PEF, asthma symptoms, night-time awakenings due to
      asthma, rescue use, and upper respiratory tract infection symptoms.

      During the double-blind treatment period the electronic Diary (eDiary) will alert the subject
      or parent/legal guardian when the data imputed into the eDiary indicates the presence of
      upper respiratory symptoms of moderate or severe severity or if the subject has reached the
      criteria for worsening asthma. Upon receipt of either of these alerts, the subject or
      parent/legal guardian will be instructed to call the clinic. The clinic will instruct the
      subject (parent/legal guardian) to provide a mucus sample for assessment of viral respiratory
      infection. Mucus samples for viral respiratory assessment will not be collected from subjects
      more than once in a 7 day period. During the randomization visit subjects will receive
      training on the at home collection of a mucus sample.

      Throughout the study each subject will be instructed to rate their daily upper respiratory
      symptoms. Upper respiratory tract symptoms include: runny nose, sneezing, nasal congestion,
      and sore throat. Subjects will be instructed to select a rating from the following list that
      best describes their aggregate upper respiratory symptoms during the previous 24 hours.

      This study will evaluate the effects of the ADVAIR™ DISKUS™ 100/50 mcg and FLOVENT™ DISKUS™
      100 mcg on clinical parameters and indices of airway inflammation associated with viral
      respiratory tract infections in pediatric asthmatic subjects. Safety will be assessed by
      monitoring adverse events.
    

Intervention name(s): FLOVENT™ DISKUS™ 100 mcg BID; ADVAIR™ DISKUS™ 100/50 mcg BID
Intervention type(s): Drug; Drug
Intervention description(s): FLOVENT™ DISKUS™ 100 mcg, one inhalation twice daily (BID) from the DISKUS device from randomization through the end of study (week 16).; ADVAIR™ DISKUS™ 100/50 mcg is a combination product containing a 100 mcg fluticasone propionate and a 50 mcg salmeterol. One inhalation from the DISKUS device twice daily (BID) from randomization through end of study (week 16).
Other intervention name(s): Fluticasone propionate; Fluticasone propionate/salmeterol combination
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pediatric; exacerbation; viral induced exacerbation; asthma