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

March 22, 2015 updated by: Meda Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Center of Alabama,LLC
    • Alaska
      • Little Rock, Alaska, United States, 72205
        • Little Rock Allergy and Asthma Clinical Research Center
    • California
      • Costa Mesa, California, United States, 92626
        • West Coast Clinical Trials
      • Long Beach, California, United States, 90808
        • Allergy & Asthma Care Center of So. Cal
      • Mission Viejo, California, United States, 92691
        • Southern California Research
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group Inc
      • San Jose, California, United States, 95117
        • Allergy & Asthma Associates of Santa Clara Valley Research Cntr
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Storms Clinical Research Institute
      • Denver, Colorado, United States, 80230
        • Colorado Allergy and Asthma Centers, PC
      • Pueblo, Colorado, United States, 81001
        • Asthma and Allergy Associates, PC
    • Florida
      • Ocala, Florida, United States, 34471
        • Allergy and Asthma Care of Florida
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Atlanta Allergy and Asthma Clinic
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Idaho Allergy
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze and Itch Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Clinical Research Institute of Indiana
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Family Allergy and Asthma Reserach
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Research Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Reseacrh Institute
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • The Clinical Research Center
      • Warrensburg, Missouri, United States, 64093
        • Clinical Research of the Ozarks,Inc
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Midwest Allergy and Asthma Clinic
      • Papillion, Nebraska, United States, 68046
        • The Asthma and Allergy Center, PC
    • New Jersey
      • Ocean, New Jersey, United States, 07712
        • Atlantic Research Center
      • Warren, New Jersey, United States, 07059
        • Asthma, Sinus & Allergy Centers, LLC
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma & Clinical Research Center
      • Oklahoma City, Oklahoma, United States, 73131
        • Oklahoma Institute of Allergy and Asthma
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Baker Allergy Asthma & Dermatology Ctr LLC
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • Allergy and Asthma Specialist PC
      • Charleston, Pennsylvania, United States, 29406
        • National Allergy, Asthna & Urticaria Centers of Charleston Pa
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
      • Upland, Pennsylvania, United States, 19013
        • Asthma and Allergy Research Associate
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • ADAC research, PA
    • Texas
      • Dallas, Texas, United States, 75231
        • AARA Research Center
      • Dallas, Texas, United States, 75246
        • Texas Allergy Research Center
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78233
        • Live Oak Allergy and Asthma Clinic
      • San Antonio, Texas, United States, 78229
        • Paul H Ratner,MD
      • Waco, Texas, United States, 76712
        • Allergy Asthma Research Institute
      • Waco, Texas, United States, 76712
        • Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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)

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dymista nasal spray
azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months
Drug: Dymista Nasal Spray
Active Comparator: fluticasone propionate nasal spray
fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Drug: Fluticasone propionate nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Report
Time Frame: 3 months of treatment
reports of treatment emergent adverse events
3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meda Pharmaceuticals

Investigators

  • Study Director: Nancy Ruiz, M.D., Sponsor GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 22, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP 4007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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