Clinical trial NCT01520688
Conditions: Asthma
Keywords: Mild persistent or mild intermittent asthma
Sponsor: West Penn Allegheny Health System
Start date: 2012-02-01; Completion date: 2016-02-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Arms: arm 1: Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR arm 2: Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort arm 3: Period 2 Pulmicort Period 4 Flovent Period 6 QVAR arm 4: Period 2 Pulmicort Period 4 QVAR Period 6 Flovent arm 5: Period 2 QVAR Period 4 Flovent Period 6 Pulmicort arm 6: Period 2 QVAR Period 4 Pulmicort Period 6 Flovent
Interventions: intervention 1: Fluticasone, Budesonide, Beclomethasone intervention 2: Fluticasone, Beclomethasone, Budesonide intervention 3: Budesonide, Fluticasone, Beclomethasone intervention 4: Budesonide, Beclomethasone, Fluticasone intervention 5: Beclomethasone, Fluticasone, Budesonide intervention 6: Beclomethasone, Budesonide, Fluticasone
Intervention descriptions: intervention 1: Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid intervention 2: Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID intervention 3: Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID intervention 4: Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID intervention 5: Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID intervention 6: Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID

Protocol documents: