Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80
      mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with
      asthma.

      Objectives:

        1. The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg
           BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as
           measured by knemometry in pediatric subjects with mild asthma.

        2. The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg
           BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by
           knemometry in pediatric subjects with mild asthma.

      Aims:

        1. The primary aim is to show that there is a growth suppressive effect of Pulmicort
           Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.

        2. The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID
           versus Flovent Diskus 100 mcg BID in children with mild asthma.

      Hypotheses:

        1. The primary hypothesis is that treatment with Pulmicort Flexhaler 180mcg BID as compared
           to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as
           assessed by knemometry in pediatric subjects with mild asthma.

        2. The secondary hypothesis is that treatment with QVAR 80 mcg BID as compared to Flovent
           Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by
           knemometry in pediatric subjects with mild asthma.
    

Intervention name(s): Fluticasone, Budesonide, Beclomethasone; Fluticasone, Beclomethasone, Budesonide; Budesonide, Fluticasone, Beclomethasone; Budesonide, Beclomethasone, Fluticasone; Beclomethasone, Fluticasone, Budesonide; Beclomethasone, Budesonide, Fluticasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Flovent Diskus; Pulmicort Flexhaler; QVAR; Flovent Diskus; Pulmicort Flexhaler; QVAR; Pulmicort Flexhaler; Flovent Diskus; QVAR; Pulmicort Flexhaler; QVAR; Flovent Diskus; QVAR; Flovent Diskus; Pulmicort Flexhaler; QVAR; Pulmicort Flexhaler; flovent Diskus
Intervention MeSH terms: Fluticasone; Xhance; Budesonide; Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild persistent or mild intermittent asthma