Completed

Randomized Trial of the Safety of Dymista Nasal Spray and Fluticasone Propionate Nasal Spray in Children Ages >4 Years to <12 Years With Allergic Rhinitis

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What is being tested

Dymista Nasal Spray

+ Fluticasone propionate nasal spray

Drug
Who is being recruted

Hypersensitivity+6

+ Hypersensitivity, Immediate

+ Immune System Diseases

From 4 to 11 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorMeda Pharmaceuticals
Last updated: March 31, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis

NCT01794741
Principal SponsorMeda Pharmaceuticals
Last updated: March 31, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

405 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 11 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypersensitivityHypersensitivity, ImmediateImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, Allergic

Criteria

7 inclusion criteria required to participate
A history of allergic rhinitis (AR)
General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
Male and female subjects >= 4 years to < 12 years, inclusive at the screening visit
Require treatment with Dymista Nasal Spray, based on the Investigator's assessment (based on medical history, physical examination, etc.) of the subjects' clinical condition, at both the Screening and Randomization Visits
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17 exclusion criteria prevent from participating
Any behavioral condition which could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism
Chronic obstructive sleep apnea syndrome (clinical diagnosis)
Clinically relevant abnormal physical findings or laboratory results which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug or that might significantly affect the subject's ability to complete this trial
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months

Group II

Active Comparator
fluticasone propionate nasal spray 50mcg per spray per nostril twice a day

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 41 locations

Clinical Research Center of Alabama,LLC

Birmingham, United StatesOpen Clinical Research Center of Alabama,LLC in Google Maps

Little Rock Allergy and Asthma Clinical research Center

Little Rock, United States

West Coast Clinical Trials

Costa Mesa, United States

Allergy &amp; Asthma Care Center of So. Cal

Long Beach, United States
Completed41 Study Centers