Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
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
1 other identifier
interventional
348
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedResults Posted
Study results publicly available
June 29, 2015
CompletedJune 29, 2015
June 1, 2015
7 months
August 1, 2013
March 22, 2015
June 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Efficacy
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.
15 days of treatment
Secondary Outcomes (1)
Safety
entire length of study (day 1 to day 22)
Other Outcomes (1)
Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
day 1 to day 15 of treatment
Study Arms (2)
Dymista
ACTIVE COMPARATOR(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
Dymista vehicle
PLACEBO COMPARATORDose: vehicle only Regimen: 1 spray per nostril twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
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 City, 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
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, 29407, United States
Allergy and Asthma Consultants, LLP
Charleston, South Carolina, 29414, 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
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, United States
Immunology/allergy and asthma Care of Waco
Waco, Texas, 76712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr.Nancy Ruiz,MD
- Organization
- Meda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2013
First Posted
August 5, 2013
Study Start
July 1, 2013
Primary Completion
February 1, 2014
Last Updated
June 29, 2015
Results First Posted
June 29, 2015
Record last verified: 2015-06