drugset / Trial / NCT01550471
Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |