CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo +5 moredrug
Likely dose
Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo 200 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01550471
NCT01550471Phase 4Completed
CompareCT.gov

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

West Penn Allegheny Health System·interventional·Posted Mar 12, 2012·Updated Nov 4, 2020

In Brief

A Phase 4 clinical trial evaluating Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase, and 4 other interventions for Asthma and Allergic Rhinitis. Completed, enrolled 22 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Allergic Rhinitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2012
Enrollment StartMar 1, 2012
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.3 years ago

Interventions

Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebodrug

Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID

Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconasedrug

Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID

QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebodrug

QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID

QVAR/Beconase, Placebo/Placebo, Alvesco/Omnarisdrug

QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD

Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconasedrug

Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID

Placebo/Placebo, QVAR/Beconase, Alvesco/Omnarisdrug

Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD