Phase
Condition
Allergies & Asthma
Acute Rhinitis
Nasal Obstruction
Treatment
N/AClinical Study ID
Ages 4-11 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 provideassent
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' clinicalcondition, at both the Screening and Randomization Visits
General good health and free of any disease or concomitant treatment that couldinterfere with the interpretation of the study results as determined by theinvestigator or the sponsor's medical officer
Subjects receiving immunotherapy injections (antigen desensitization) must be on astable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections do not precludeparticipation)
Exclusion
Exclusion Criteria:
On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasalmucosal erosion, nasal mucosal ulceration, nasal septum perforation
Nasal disease(s) likely to affect deposition of intranasal medication, such as acuteor chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis orclinically 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. Noinvestigational products are permitted for use during the conduct of this study
Presence of any hypersensitivity to azelastine hydrochloride and/or fluticasonepropionate 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 withintermittent asthma who only require short-acting inhaled bronchodilators (not moreoften than twice per week) and who do not have nocturnal awakening as a result ofasthma are eligible for enrollment
Chronic obstructive sleep apnea syndrome (clinical diagnosis)
Existence of any surgical or medical condition, which in the opinion of theinvestigator or sponsor's medical monitor, might significantly alter the absorption,distribution, metabolism, or excretion of study drug or that might significantlyaffect the subject's ability to complete this trial
Clinically relevant abnormal physical findings or laboratory results which, in theopinion of the investigator, would interfere with the objectives of the study or thatmay preclude compliance with the study procedures
Family members of research center or private practice personnel who are directlyinvolved 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 safetyevaluations (see Sections 4.0 and 5.0) and have not had the proper washouts from thesemedications or therapies
Any behavioral condition which could affect subject's ability to accurately reportsymptoms to the caregiver such as developmental delay, attention deficit disorder, andautism
Positive pregnancy test in female subjects ≥ 9 years of age
Females who are pregnant or nursing practicing a medically acceptable method ofcontraception
Subjects who fail to complete the symptom diary during the lead-in period, defined asmissing data for >50% of entries
Study Design
Connect with a study center
Clinical Research Center of Alabama,LLC
Birmingham, Alabama 35209
United StatesSite Not Available
Little Rock Allergy and Asthma Clinical research Center
Little Rock, Alaska 72205
United StatesSite Not Available
West Coast Clinical Trials
Costa Mesa, California 92626
United StatesSite Not Available
Allergy & Asthma Care Center of So. Cal
Long Beach, California 90808
United StatesSite Not Available
Southern California Research
Mission Viejo, California 92691
United StatesSite Not Available
Allergy Associates Medical Group Inc
San Diego, California 92120
United StatesSite Not Available
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
San Jose, California 95117
United StatesSite Not Available
Storms Clinical Research Institute
Colorado Springs, Colorado 80907
United StatesSite Not Available
Colorado Allergy and Asthma Centers, PC
Denver, Colorado 80230
United StatesSite Not Available
Asthma and Allergy Associates, PC
Pueblo, Colorado 81001
United StatesSite Not Available
Allergy and Asthma Care of Florida
Ocala, Florida 34471
United StatesSite Not Available
Atlanta Allergy and Asthma Clinic
Stockbridge, Georgia 30281
United StatesSite Not Available
Idaho Allergy
Eagle, Idaho 83616
United StatesSite Not Available
Sneeze, Wheeze and Itch Associates
Normal, Illinois 61761
United StatesSite Not Available
Clinical Research Institute of Indiana
Indianapolis, Indiana 46208
United StatesSite Not Available
Family Allergy and Asthma Reserach
Louisville, Kentucky 40215
United StatesSite Not Available
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan 48197
United StatesSite Not Available
Clinical Reseacrh Institute
Minneapolis, Minnesota 55402
United StatesSite Not Available
The Clinical Research Center
St. Louis, Missouri 63141
United StatesSite Not Available
Clinical Research of the Ozarks,Inc
Warrensburg, Missouri 64093
United StatesSite Not Available
Midwest Allergy and Asthma Clinic
Omaha, Nebraska 68130
United StatesSite Not Available
The Asthma and Allergy Center, PC
Papillion, Nebraska 68046
United StatesSite Not Available
Atlantic Research Center
Ocean, New Jersey 07712
United StatesSite Not Available
Asthma, Sinus & Allergy Centers, LLC
Warren, New Jersey 07059
United StatesSite Not Available
North Carolina Clinical Research
Raleigh, North Carolina 27607
United StatesSite Not Available
Bernstein Clinical Research Center
Cincinnati, Ohio 45231
United StatesSite Not Available
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Oklahoma Institute of Allergy and Asthma
Oklahoma City, Oklahoma 73131
United StatesSite Not Available
Baker Allergy Asthma & Dermatology Ctr LLC
Lake Oswego, Oregon 97035
United StatesSite Not Available
Allergy and Asthma Specialist PC
Blue Bell, Pennsylvania 19422
United StatesSite Not Available
National Allergy, Asthna & Urticaria Centers of Charleston Pa
Charleston, Pennsylvania 29406
United StatesSite Not Available
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Asthma and Allergy Research Associate
Upland, Pennsylvania 19013
United StatesSite Not Available
ADAC Research, PA
Greenville, South Carolina 29607
United StatesSite Not Available
AARA Research Center
Dallas, Texas 75231
United StatesSite Not Available
Texas Allergy Research Center
Dallas, Texas 75246
United StatesSite Not Available
Central Texas Health Research
New Braunfels, Texas 78130
United StatesSite Not Available
Live Oak Allergy and Asthma Clinic
San Antonio, Texas 78233
United StatesSite Not Available
Paul H Ratner,MD
San Antonio, Texas 78229
United StatesSite Not Available
Allergy Asthma Research Institute
Waco, Texas 76712
United StatesSite Not Available
Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco
Waco, Texas 76712
United StatesSite Not Available
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