Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Asthma Clinical Trial

Official title: A Study Evaluating the Effect of Omnaris Nasal Spray 200 mcg QD & Alvesco Inhalation Aerosol 80 BID vs Beconase AQ Nasal Spray 168 mcg BID & QVAR Inhalation Aerosol 40 mcg BID vs Placebo Nasal Spray QD & Placebo Inhalation Aerosol BID on Short Term Growth in Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

This will be a single-center, cross-over study evaluating the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID versus Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID on short term growth in pediatric subjects with mild asthma and allergic rhinitis. During the course of the study, subjects will be seen on a weekly basis and lower leg length will be measured using knemometry. 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. During the run-in and wash-out periods, subjects will not be treated with any medications or placebos. During the active treatment periods, subjects will be treated with Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID or Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID, or Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID. Eligible subjects will be randomized into the study which will contain one run-in period (Period 1), 3 active treatment periods (Periods 2, 4 and 6) and 2 washout periods (Periods 3 and 5). Each period will be of 3 weeks duration and the entire study duration will be 18 weeks. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry. ;

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

• NCT number: NCT01550471
• Study type: Interventional
• Source: West Penn Allegheny Health System
• Status: Completed
• Phase: Phase 4
• Start date: March 2012
• Completion date: August 2015