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

Phase 3

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Dymista vehicle
Drug: azelastine hydrochloride and fluticasone propionate

Registration Number: NCT01915823

Lead Sponsor: Meda Pharmaceuticals

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 348

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dymista vehicle	Dymista vehicle	Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista	azelastine hydrochloride and fluticasone propionate	(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily

Primary Outcome Measures

Name	Time	Method
Primary Efficacy	15 days of treatment	change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.

Secondary Outcome Measures

Name	Time	Method
Safety	entire length of study (day 1 to day 22)	* Subject-reported adverse experiences (incidence, type, and severity of adverse events) * Nasal Examinations * Vital signs assessments

Trial Locations

Locations (31): Clinical Research Atlanta
🇺🇸
Atlanta, Georgia, United States
Little Rock Allergy and Asthma Clinical research Center
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Little Rock, Alaska, United States
Clinical Research Center of Alabama,LLC
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Birmingham, Alabama, United States
Atlanta Allergy and Asthma Clinic
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Stockbridge, Georgia, United States
Aeroallergy Research Laboratories of Savannah
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Savannah, Georgia, United States
Sneeze, Wheeze and Itch Associates
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Normal, Illinois, United States
Clinical Research Institute of Indiana
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Indianapolis, Indiana, United States
Family Allergy and Asthma Reserach
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Louisville, Kentucky, United States
Institute for Asthma and Allergy PC
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Wheaton, Maryland, United States
Respiratory Medicine Research Institute of Michigan
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Ypsilanti, Michigan, United States
The Clinical Research Center
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St. Louis, Missouri, United States
Clinical Research Institute
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Plymouth, Minnesota, United States
Allergy and Asthma Consultants, LLP
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Charleston, South Carolina, United States
Isis Clinical Research, LLC
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Ausitn, Texas, United States
Central Texas Health Research
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New Braunfels, Texas, United States
Sirius Clinical Research
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Austin, Texas, United States
Sylvana Research Associates
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San Antonio, Texas, United States
Live Oak Allergy and Asthma Clinic
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San Antonio, Texas, United States
Atlantic Research Center
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Ocean, New Jersey, United States
Princeton Center for Clinical Research
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Skillman, New Jersey, United States
Clinical Research of the Ozarks,Inc
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Warrensburg, Missouri, United States
Allergy and Asthma Research NJ inc
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Mount Laurel, New Jersey, United States
Asthma and Allergy Research Associate
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Upland, Pennsylvania, United States
Allergy, Asthma & Clinical Research Center
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Oklahoma City, Oklahoma, United States
Allergy Asthma Research Institute
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Waco, Texas, United States
North Carolina Clinical Research
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Raleigh, North Carolina, United States
Allergy and Asthma Specialist PC
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Blue Bell, Pennsylvania, United States
Bernstein Clinical Research Center
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Cincinnati, Ohio, United States
Oklahoma Institute of Allergy and Asthma
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Oklahoma City, Oklahoma, United States
National Allergy, Asthma and Urticaria of Charleston
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Charleston, South Carolina, United States
Immunology/allergy and asthma Care of Waco
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Waco, Texas, United States