drugset / Trial / NCT01550471

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

NCT01550471

Phase 4 Completed 22 enrolled West Penn Allegheny Health System
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2012-03
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Beclomethasone Small molecule 40 ug Intranasal
Subject Beclomethasone Small molecule 168 ug Intranasal
Subject Ciclesonide Other / unclassified 80 ug Intranasal
Subject Ciclesonide Other / unclassified 200 ug Intranasal