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

Last updated: March 22, 2015
Sponsor: Meda Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Acute Rhinitis

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT01794741
MP 4007
  • Ages 4-11
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

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

Total Participants: 405
Study Start date:
February 01, 2013
Estimated Completion Date:

Connect with a study center

  • Clinical Research Center of Alabama,LLC

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Little Rock Allergy and Asthma Clinical research Center

    Little Rock, Alaska 72205
    United States

    Site Not Available

  • West Coast Clinical Trials

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Allergy & Asthma Care Center of So. Cal

    Long Beach, California 90808
    United States

    Site Not Available

  • Southern California Research

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Allergy Associates Medical Group Inc

    San Diego, California 92120
    United States

    Site Not Available

  • Allergy & Asthma Associates of Santa Clara Valley Research Cntr

    San Jose, California 95117
    United States

    Site Not Available

  • Storms Clinical Research Institute

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Colorado Allergy and Asthma Centers, PC

    Denver, Colorado 80230
    United States

    Site Not Available

  • Asthma and Allergy Associates, PC

    Pueblo, Colorado 81001
    United States

    Site Not Available

  • Allergy and Asthma Care of Florida

    Ocala, Florida 34471
    United States

    Site Not Available

  • Atlanta Allergy and Asthma Clinic

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Idaho Allergy

    Eagle, Idaho 83616
    United States

    Site Not Available

  • Sneeze, Wheeze and Itch Associates

    Normal, Illinois 61761
    United States

    Site Not Available

  • Clinical Research Institute of Indiana

    Indianapolis, Indiana 46208
    United States

    Site Not Available

  • Family Allergy and Asthma Reserach

    Louisville, Kentucky 40215
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Clinical Reseacrh Institute

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • The Clinical Research Center

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Clinical Research of the Ozarks,Inc

    Warrensburg, Missouri 64093
    United States

    Site Not Available

  • Midwest Allergy and Asthma Clinic

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • The Asthma and Allergy Center, PC

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Atlantic Research Center

    Ocean, New Jersey 07712
    United States

    Site Not Available

  • Asthma, Sinus & Allergy Centers, LLC

    Warren, New Jersey 07059
    United States

    Site Not Available

  • North Carolina Clinical Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Bernstein Clinical Research Center

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oklahoma Institute of Allergy and Asthma

    Oklahoma City, Oklahoma 73131
    United States

    Site Not Available

  • Baker Allergy Asthma & Dermatology Ctr LLC

    Lake Oswego, Oregon 97035
    United States

    Site Not Available

  • Allergy and Asthma Specialist PC

    Blue Bell, Pennsylvania 19422
    United States

    Site Not Available

  • National Allergy, Asthna & Urticaria Centers of Charleston Pa

    Charleston, Pennsylvania 29406
    United States

    Site Not Available

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Asthma and Allergy Research Associate

    Upland, Pennsylvania 19013
    United States

    Site Not Available

  • ADAC Research, PA

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • AARA Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Allergy Research Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Central Texas Health Research

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • Live Oak Allergy and Asthma Clinic

    San Antonio, Texas 78233
    United States

    Site Not Available

  • Paul H Ratner,MD

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Allergy Asthma Research Institute

    Waco, Texas 76712
    United States

    Site Not Available

  • Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco

    Waco, Texas 76712
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.