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

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Rhinitis

Intervention: Dymista Nasal Spray (Drug); Fluticasone propionate nasal spray (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

Official(s) and/or principal investigator(s):
Nancy Ruiz, M.D., Study Director, Affiliation: Sponsor GmbH

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adverse Events Report

Eligibility

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Clinical Research Center of Alabama,LLC, Birmingham, Alabama 35209, United States

Little Rock Allergy and Asthma Clinical research Center, Little Rock, Alaska 72205, United States

West Coast Clinical Trials, Costa Mesa, California 92626, United States

Allergy & Asthma Care Center of So. Cal, Long Beach, California 90808, United States

Southern California Research, Mission Viejo, California 92691, United States

Allergy Associates Medical Group Inc, San Diego, California 92120, United States

Allergy & Asthma Associates of Santa Clara Valley Research Cntr, San Jose, California 95117, United States

Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States

Colorado Allergy and Asthma Centers, PC, Denver, Colorado 80230, United States

Asthma and Allergy Associates, PC, Pueblo, Colorado 81001, United States

Allergy and Asthma Care of Florida, Ocala, Florida 34471, United States

Atlanta Allergy and Asthma Clinic, Stockbridge, Georgia 30281, United States

Idaho Allergy, Eagle, Idaho 83616, United States

Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States

Clinical Research Institute of Indiana, Indianapolis, Indiana 46208, United States

Family Allergy and Asthma Reserach, Louisville, Kentucky 40215, United States

Respiratory Medicine Research Institute of Michigan, Ypsilanti, Michigan 48197, United States

Clinical Reseacrh Institute, Minneapolis, Minnesota 55402, United States

The Clinical Research Center, St. Louis, Missouri 63141, United States

Clinical Research of the Ozarks,Inc, Warrensburg, Missouri 64093, United States

Midwest Allergy and Asthma Clinic, Omaha, Nebraska 68130, United States

The Asthma and Allergy Center, PC, Papillion, Nebraska 68046, United States

Atlantic Research Center, Ocean, New Jersey 07712, United States

Asthma, Sinus & Allergy Centers, LLC, Warren, New Jersey 07059, United States

North Carolina Clinical Research, Raleigh, North Carolina 27607, United States

Bernstein Clinical Research Center, Cincinnati, Ohio 45231, United States

Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States

Oklahoma Institute of Allergy and Asthma, Oklahoma City, Oklahoma 73131, United States

Baker Allergy Asthma & Dermatology Ctr LLC, Lake Oswego, Oregon 97035, United States

Allergy and Asthma Specialist PC, Blue Bell, Pennsylvania 19422, United States

National Allergy, Asthna & Urticaria Centers of Charleston Pa, Charleston, Pennsylvania 29406, United States

Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, United States

Asthma and Allergy Research Associate, Upland, Pennsylvania 19013, United States

ADAC Research, PA, Greenville, South Carolina 29607, United States

AARA Research Center, Dallas, Texas 75231, United States

Texas Allergy Research Center, Dallas, Texas 75246, United States

Central Texas Health Research, New Braunfels, Texas 78130, United States

Live Oak Allergy and Asthma Clinic, San Antonio, Texas 78233, United States

Paul H Ratner,MD, San Antonio, Texas 78229, United States

Allergy Asthma Research Institute, Waco, Texas 76712, United States

Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco, Waco, Texas 76712, United States

Additional Information

Starting date: February 2013
Last updated: March 22, 2015

Page last updated: August 23, 2015

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