Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
NCT ID: NCT01915823
Last Updated: 2015-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
348 participants
INTERVENTIONAL
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dymista
(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
azelastine hydrochloride and fluticasone propionate
Dymista vehicle
Dose: vehicle only Regimen: 1 spray per nostril twice daily
Dymista vehicle
Interventions
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azelastine hydrochloride and fluticasone propionate
Dymista vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
11 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center of Alabama,LLC
Birmingham, Alabama, United States
Little Rock Allergy and Asthma Clinical research Center
Little Rock, Alaska, United States
Clinical Research Atlanta
Atlanta, Georgia, United States
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, United States
Atlanta Allergy and Asthma Clinic
Stockbridge, Georgia, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Clinical Research Institute of Indiana
Indianapolis, Indiana, United States
Family Allergy and Asthma Reserach
Louisville, Kentucky, United States
Institute for Asthma and Allergy PC
Wheaton, Maryland, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
Clinical Research of the Ozarks,Inc
Warrensburg, Missouri, United States
Allergy and Asthma Research NJ inc
Mount Laurel, New Jersey, United States
Atlantic Research Center
Ocean City, New Jersey, United States
Princeton Center for Clinical Research
Skillman, New Jersey, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Oklahoma Institute of Allergy and Asthma
Oklahoma City, Oklahoma, United States
Allergy and Asthma Specialist PC
Blue Bell, Pennsylvania, United States
Asthma and Allergy Research Associate
Upland, Pennsylvania, United States
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, United States
Allergy and Asthma Consultants, LLP
Charleston, South Carolina, United States
Isis Clinical Research, LLC
Ausitn, Texas, United States
Sirius Clinical Research
Austin, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
Immunology/allergy and asthma Care of Waco
Waco, Texas, United States
Countries
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Other Identifiers
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MP 4008
Identifier Type: -
Identifier Source: org_study_id
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