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Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)

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

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: azelastine hydrochloride and fluticasone propionate (Drug); Dymista vehicle (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

Summary

The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.

Clinical Details

Official title: Randomized, Double-Blind Trial of the Safety and Efficacy of Dymista Nasal Spray Compared to Placebo Nasal Spray in the Treatment of Children Ages >4 Years to <12 Years With Seasonal Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Primary Efficacy

Secondary outcome: Safety

Eligibility

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

Criteria:

Inclusion Criteria:

- Male and female subjects ages >4 years to <12 years of age, inclusive at the

screening visit

- The parent/caregiver must provide written informed consent and the child must provide

pediatric assent, if possible

- Willing and able to comply with the study requirements

- Have a history of seasonal allergic rhinitis (SAR) to pollen in the prevailing

allergy season.

- The presence of immunoglobulin E (IgE)-mediated hypersensitivity to prevailing

pollen, confirmed by a positive response to skin prick test. A histamine skin test must also be positive. A positive response for both the pollen skin test and the histamine skin test is defined as a wheal diameter of at least 4 mm larger than the negative saline control

- 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

- On the first day of the placebo lead-in period (Visit 1) subjects must have a 12-hour

reflective total nasal symptoms score (rTNSS )of ≥6 and a reflective congestion score of ≥2 to qualify for entry. At Visit 2:

- Have taken at least 6 doses of the placebo lead-in medication during the placebo

lead-in period

- At Visit 2, to be eligible for entry into the double-blind treatment period, subjects

must have the total of the seven lead-in symptom assessments during the past 3 days of the lead-in period including the Day of Randomization (Visit 2, Day 1):

- a 12-hour reflective TNSS ≥ 42

- a 12-hour reflective congestion score of ≥14

Exclusion Criteria:

- On nasal examination, the presence of any superficial or moderate nasal mucosal

erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1B - 4) at

either the screening visit or randomization visit

- 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 signing the informed

consent/pediatric assent at 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 14 days prior to Visit1

- 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 that might significantly affect the subject's ability to complete this trial

- Clinically relevant abnormal physical findings which, in the opinion of the

investigator or sponsor's medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures

- Family members of the research center or private practice personnel who are directly

involved in this study are excluded

- Members of the same household cannot be enrolled at the same time

- Subjects who have used medications or therapies that could interfere with safety and

efficacy evaluations 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

- Females of childbearing potential who are not abstinent and not 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

- 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 regimens following a brief period of missed injections do not preclude participation). Dose reduction when a new bottle is used does not preclude participation.

- Planned travel outside of the pollen area during the study period

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

Clinical Research Atlanta, Atlanta, Georgia 30342, United States

Aeroallergy Research Laboratories of Savannah, Savannah, Georgia 31406, United States

Atlanta Allergy and Asthma Clinic, Stockbridge, Georgia 30281, 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

Institute for Asthma and Allergy PC, Wheaton, Maryland 20902, United States

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

Clinical Research Institute, Plymouth, 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

Allergy and Asthma Research NJ inc, Mount Laurel, New Jersey 08054, United States

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

Princeton Center for Clinical Research, Skillman, New Jersey 08558, 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

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

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

Allergy and Asthma Consultants, LLP, Charleston, South Carolina 29414, United States

National Allergy, Asthma and Urticaria of Charleston, Charleston, South Carolina 29407, United States

Isis Clinical Research, LLC, Ausitn, Texas 78731, United States

Sirius Clinical Research, Austin, Texas 78759, United States

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

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

Sylvana Research Associates, San Antonio, Texas 78229, United States

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

Immunology/allergy and asthma Care of Waco, Waco, Texas 76712, United States

Additional Information

Starting date: July 2013
Last updated: June 9, 2015

Page last updated: August 23, 2015

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