Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone/salmeterol 250/50 Dry Powder Inhaler; fluticasone/salmeterol 100/50 Dry Powder Inhaler; fluticasone 100mcg Dry Powder Inhaler
Intervention description: Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization; Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization; Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Asthma; Clinical Trial Design; Electronic Data Entry; Mobile Devices; Home Spirometry

Summary:

      Asthma is an inflammatory disease that imposes a significant burden affecting an estimated
      300 million persons and 20% of all children worldwide. It is one of the most common chronic
      diseases of childhood and is a leading cause of school absenteeism. There continues to be a
      great need for clinical trials in asthma but traditional clinical trials are expensive and
      reasons cited by patients for non-participation are extra inconvenience and logistical
      barriers. Study designs which are patient centered and reduce trial costs are needed. The
      long-range goal of this application is to transform the paradigm of clinical research into a
      more efficient and cost-effective enterprise by capitalizing upon current widely used mobile
      electronic means of communication and information transfer.

      This innovative project is a streamlined clinical trial that will run concurrently with a
      nearly identical traditional clinical trial, "Long-acting Beta Agonist Step Down Study"
      (LASST) which will allow for direct comparison of processes and outcomes between the
      streamlined and traditional approach. Children 12 to 17 years old with asthma will be
      randomized to participate in this project (streamlined trial) or LASST (traditional trial).
      In this proposal we will: measure comprehension of study information using an original
      questionnaire, Research Participant Assessment (developed at Nemours), following a parental
      permission/assent process delivered over the internet in a dynamic interactive multi-media
      format (Specific Aim 1); measure the efficiency of participant driven data entry from home
      into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality
      of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad
      (Specific Aim 2); test whether the streamlined approach has a "trial effect" by comparing the
      differences in Asthma Control Test (ACT) scores following 12 weeks of study drug treatment in
      children randomized to this project compared to LASST. We will collect effort reporting data
      to compare personnel costs between the trials. If this streamlined project lacks a "trial
      effect" and reduces costs compared to LASST, the methodologies would be generalizable to
      studies which include adults and other diseases.
    

Eligibility criteria:

        Main Trial

        Inclusion Criteria:

          -  Age 12-17 years

          -  Physician diagnosed asthma (without any other co-morbid pulmonary disease) that is
             well-controlled on medium dose inhaled corticosteroid and long-acting β2-agonist given
             twice daily [Advair Diskus (fluticasone propionate/salmeterol) 250/50mcg; Advair HFA
             (hydrofluoroalkane) (fluticasone propionate/salmeterol hydrofluoroalkane) 115/21mcg;
             Symbicort (budesonide/formoterol) 160/4.5mcg; Dulera (mometasone/formoterol)
             100/4.5mcg] based on an ACT score > 20, and the absence of unscheduled visits or use
             of rescue prednisone for 4 weeks prior to enrollment

          -  Pre-bronchodilator forced expiratory volume in the first second > 70% predicted

          -  < 10 pack/year history of tobacco use and abstinence for at least 1 year

        Exclusion Criteria:

          -  Chronic oral steroid therapy

          -  Hospitalization or urgent care visit within 4 weeks of the screening visit

          -  Near fatal asthma within 2 years of enrollment or high risk of near fatal or fatal
             asthma 125-127

          -  Women who are pregnant or lactating

        Parallel MICT and Parallel LASST

        Inclusion Criteria:

          -  Age 12-17 years

          -  Physician diagnosed asthma (without any other co-morbid pulmonary disease) that is
             well-controlled on medium dose inhaled corticosteroid and long-acting β2-agonist given
             twice daily [Advair Diskus (fluticasone propionate/salmeterol) 250/50mcg; Advair HFA
             (hydrofluoroalkane) (fluticasone propionate/salmeterol hydrofluoroalkane) 115/21mcg;
             Symbicort (budesonide/formoterol) 160/4.5mcg; Dulera (mometasone/formoterol)
             100/4.5mcg] based on an ACT score > 20, and the absence of unscheduled visits or use
             of rescue prednisone for 4 weeks prior to enrollment

          -  < 10 pack/year history of tobacco use and abstinence for at least 1 year

        Exclusion Criteria:

          -  Chronic oral steroid therapy

          -  Hospitalization or urgent care visit within 4 weeks of the screening visit

          -  Near fatal asthma within 2 years of enrollment or high risk of near fatal or fatal
             asthma 125-127

          -  Women who are pregnant or lactating