Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Intervention: 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 description: 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
Intervention MeSH terms: Ciclesonide; Beclomethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mild asthma and allergic rhinitis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects will include females and males 6 to 15 years of age.

          2. All subjects must have a history of physician diagnosed mild asthma and allergic
             rhinitis as documented by PCP medical record or detailed history by study
             investigator.

          3. All subjects must have a height within normal limits (5th to 95th percentile) and no
             history of abnormal growth as assessed by medical history.

          4. Subjects may be on current treatment with montelukast as this drug does not affect
             growth. If a subject is on montelukast at screening/baseline, they will remain on a
             stable dose throughout the study.

          5. Subjects must be willing to comply with study requirements.

        Exclusion Criteria:

        1. Subjects will be excluded if they have asthma greater than mild persistent severity as
        defined by NHLBI guidelines.

        2 Subjects will be excluded if they used any systemic steroids within the past 60 days.

        3. Subjects will be excluded if they had more than one burst of systemic steroids within
        the past year.

        4. Subjects will be excluded if their baseline FEV1 is < 80% predicted. 5. Subjects will be
        excluded if they have any other serious systemic disease other than asthma.

        6. Subjects will be excluded if they have taken any medication known to affect growth i.e.
        ADHD medications within the past 60 days 7. Subjects will be excluded if they have a
        history of allergy to any of the study medications.

        8. Subjects will be excluded if they have active chickenpox or measles or recent exposure
        to chickenpox or measles.

        9. Subjects will be excluded if they have any history of tuberculosis of the respiratory
        tract.

        10. Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic
        infections.

        11. Subjects will be excluded if they have any history of herpes simplex infection of the
        eye.

        12. Subjects will be excluded if they have taken any immunosuppressive drugs within the
        past 2 months.

        13. Subjects will be excluded if they have any history of Churg-Strauss syndrome or other
        eosinophilic disorders.

        14. Subjects will be excluded if an investigator deems they have any mental or development
        health issues, such as autism, moderate to severe mental retardation or severe ADHD, that
        interferes with their ability to complete the knemometry measurements.

        15. Subjects will be excluded if an investigator deems they have any physical issues, such
        as inability to sit independently or amputation of lower leg, that interferes with their
        ability to complete the knemometry measurements.