Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will provide the clinicians guidance on the safest combination of inhaled and
      nasal corticosteroids for children with mild asthma and allergic rhinitis respectively;
      however, one safety concern is that these products are independently known to have
      dose-related effects on short term and intermediate term growth. Knemometry is a non invasive
      technique for measuring short-term lower leg growth in children and is currently the method
      of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18
      weeks and at each visit, lower leg length will be measured using knemometry.
    

Detailed description: 
      This will be a single-center, cross-over study evaluating the effect of Omnaris Nasal Spray
      200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID
      and QVAR Inhalation Aerosol 40 mcg BID versus Placebo Nasal Spray QD and Placebo Inhalation
      Aerosol BID on short term growth in pediatric subjects with mild asthma and allergic
      rhinitis. During the course of the study, subjects will be seen on a weekly basis and lower
      leg length will be measured using knemometry. Knemometry is a non invasive technique for
      measuring short-term lower leg growth in children and is currently the method of choice in
      growth studies of short duration. During the run-in and wash-out periods, subjects will not
      be treated with any medications or placebos. During the active treatment periods, subjects
      will be treated with Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID or
      Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID, or Placebo Nasal
      Spray QD and Placebo Inhalation Aerosol BID. Eligible subjects will be randomized into the
      study which will contain one run-in period (Period 1), 3 active treatment periods (Periods 2,
      4 and 6) and 2 washout periods (Periods 3 and 5). Each period will be of 3 weeks duration and
      the entire study duration will be 18 weeks. Subjects will be seen on a weekly basis for 18
      weeks and at each visit, lower leg length will be measured using knemometry.
    

Intervention name(s): Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo; Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase; QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo; QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris; Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase; Placebo/Placebo, QVAR/Beconase, Alvesco/Omnaris
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID; Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID; QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID; QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD; Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID; Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD
Other intervention name(s): Ciclesonide, Beclomethasone, Placebo; Ciclesonide, Placebo, Beclomethasone; Beclomethasone, Ciclesonide, Placebo; Beclomethasone, Placebo, Ciclesonide; Placebo, Ciclesonide, Beclomethasone; Placebo, Beclomethasone, Ciclesonide
Intervention MeSH terms: Ciclesonide; Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild asthma and allergic rhinitis