3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis

Completed · Phase 3

Conditions studied: Allergic Rhinitis

In brief

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

Key facts

Study ID: NCT01794741
Run by: Meda Pharmaceuticals
People needed: 405
Starts: 2013-02-01
Last updated by the study team: 2015-03-31

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male and female subjects ≥ 4 years to <12 years, inclusive at the screening visit
A history of allergic rhinitis (AR)
The parent/caregiver must provide written informed consent and the child must provide assent
Willing and able to comply with the study requirements
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
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
Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections do not preclude participation)

You may not qualify if…

On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation
Nasal disease(s) likely to affect deposition of intranasal medication, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or clinically significant nasal structural abnormalities
Nasal surgery or sinus surgery within the previous year
The use of any investigational drug within 30 days prior to Visit 1. No investigational products are permitted for use during the conduct of this study
Presence of any hypersensitivity to azelastine hydrochloride and/or fluticasone propionate or drugs similar to azelastine hydrochloride and/or fluticasone propionate
Respiratory tract infections within two weeks prior to Visit 1.
Subjects with significant pulmonary disease including asthma. Subjects with intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
Chronic obstructive sleep apnea syndrome (clinical diagnosis)
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
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
Family members of research center or private practice personnel who are directly involved in this study are excluded
Members of the same family cannot enroll in the study at the same time.
Subjects who have used medications or therapies that could interfere with safety evaluations (see Sections 4.0 and 5.0) and have not had the proper washouts from these medications or therapies
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
Positive pregnancy test in female subjects ≥ 9 years of age
Females who are pregnant or nursing practicing a medically acceptable method of contraception
Subjects who fail to complete the symptom diary during the lead-in period, defined as missing data for >50% of entries

Where it is running

Clinical Research Center of Alabama,LLC — Birmingham, Alabama, United States
Little Rock Allergy and Asthma Clinical research Center — Little Rock, Alaska, United States
West Coast Clinical Trials — Costa Mesa, California, United States
Allergy & Asthma Care Center of So. Cal — Long Beach, California, United States
Southern California Research — Mission Viejo, California, United States
Allergy Associates Medical Group Inc — San Diego, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Cntr — San Jose, California, United States
Storms Clinical Research Institute — Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers, PC — Denver, Colorado, United States
Asthma and Allergy Associates, PC — Pueblo, Colorado, United States
Allergy and Asthma Care of Florida — Ocala, Florida, United States
Atlanta Allergy and Asthma Clinic — Stockbridge, Georgia, United States
Idaho Allergy — Eagle, Idaho, United States
Sneeze, Wheeze and Itch Associates — Normal, Illinois, United States
Clinical Research Institute of Indiana — Indianapolis, Indiana, United States
Family Allergy and Asthma Reserach — Louisville, Kentucky, United States
Respiratory Medicine Research Institute of Michigan — Ypsilanti, Michigan, United States
Clinical Reseacrh Institute — Minneapolis, Minnesota, United States
The Clinical Research Center — St Louis, Missouri, United States
Clinical Research of the Ozarks,Inc — Warrensburg, Missouri, United States
Midwest Allergy and Asthma Clinic — Omaha, Nebraska, United States
The Asthma and Allergy Center, PC — Papillion, Nebraska, United States
Atlantic Research Center — Ocean City, New Jersey, United States
Asthma, Sinus & Allergy Centers, LLC — Warren Township, New Jersey, United States
North Carolina Clinical Research — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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