Clinical trial NCT01794741: 3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 405
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Females who are pregnant or nursing 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

Primary outcomes:
measure: Adverse Events Report
timeFrame: 3 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama,LLC
state: Alabama
city: Little Rock
country: United States
facility: Little Rock Allergy and Asthma Clinical research Center
state: Alaska
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials
state: California
city: Long Beach
country: United States
facility: Allergy & Asthma Care Center of So. Cal
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group Inc
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Cntr
state: California
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Pueblo
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Ocala
country: United States
facility: Allergy and Asthma Care of Florida
state: Florida
city: Stockbridge
country: United States
facility: Atlanta Allergy and Asthma Clinic
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy
state: Idaho
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch Associates
state: Illinois
city: Indianapolis
country: United States
facility: Clinical Research Institute of Indiana
state: Indiana
city: Louisville
country: United States
facility: Family Allergy and Asthma Reserach
state: Kentucky
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Reseacrh Institute
state: Minnesota
city: St. Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Warrensburg
country: United States
facility: Clinical Research of the Ozarks,Inc
state: Missouri
city: Omaha
country: United States
facility: Midwest Allergy and Asthma Clinic
state: Nebraska
city: Papillion
country: United States
facility: The Asthma and Allergy Center, PC
state: Nebraska
city: Ocean
country: United States
facility: Atlantic Research Center
state: New Jersey
city: Warren
country: United States
facility: Asthma, Sinus & Allergy Centers, LLC
state: New Jersey
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Allergy Asthma & Dermatology Ctr LLC
state: Oregon
city: Blue Bell
country: United States
facility: Allergy and Asthma Specialist PC
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy, Asthna & Urticaria Centers of Charleston Pa
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Upland
country: United States
facility: Asthma and Allergy Research Associate
state: Pennsylvania
city: Greenville
country: United States
facility: ADAC Research, PA
state: South Carolina
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Dallas
country: United States
facility: Texas Allergy Research Center
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Paul H Ratner,MD
state: Texas
city: San Antonio
country: United States
facility: Live Oak Allergy and Asthma Clinic
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Waco
country: United States
facility: Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco
state: Texas
Study officials:
affiliation: Sponsor GmbH
name: Nancy Ruiz, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.