3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
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
1 other identifier
interventional
405
1 country
41
Brief Summary
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with 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
41 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
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedResults Posted
Study results publicly available
March 31, 2015
CompletedMarch 31, 2015
March 1, 2015
9 months
February 15, 2013
March 22, 2015
March 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events Report
reports of treatment emergent adverse events
3 months of treatment
Study Arms (2)
Dymista nasal spray
ACTIVE COMPARATORazelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months
fluticasone propionate nasal spray
ACTIVE COMPARATORfluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
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 City, New Jersey, 07712, United States
Asthma, Sinus & Allergy Centers, LLC
Warren Township, 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
Paul H Ratner,MD
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
Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco
Waco, Texas, 76712, United States
Related Publications (1)
Berger W, Sher E, Gawchik S, Fineman S. Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: A randomized clinical trial. Allergy Asthma Proc. 2018 Mar 1;39(2):110-116. doi: 10.2500/aap.2018.39.4116.
PMID: 29490769DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Nancy Ruiz, MD
- Organization
- Meda Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Nancy Ruiz, M.D.
Sponsor GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2013
First Posted
February 20, 2013
Study Start
February 1, 2013
Primary Completion
November 1, 2013
Last Updated
March 31, 2015
Results First Posted
March 31, 2015
Record last verified: 2015-03