Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone, Budesonide, Beclomethasone; Fluticasone, Beclomethasone, Budesonide; Budesonide, Fluticasone, Beclomethasone; Budesonide, Beclomethasone, Fluticasone; Beclomethasone, Fluticasone, Budesonide; Beclomethasone, Budesonide, Fluticasone
Intervention description: Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid; Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID; Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID; Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID; Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID; Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID
Intervention MeSH terms: Fluticasone; Xhance; Budesonide; Beclomethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mild persistent or mild intermittent asthma

Summary:

      Children with mild persistent asthma that have asthma symptoms once or twice a week and use a
      daily controller, while children with mild intermittent asthma rarely have asthma symptoms
      and do not use a daily controller. Inhaled corticosteroids are the standard treatment for
      mild peristent asthma. The purpose of this study is to measure children rate of growth while
      on different inhaled corticosteroids.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).

          2. All subjects must have a history of physician diagnosed mild intermittent or mild
             persistent asthma 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. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by
             physical examination.

          5. 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.

          6. 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 or nasal 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, milk protein or lactose.

          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.