Allergic Rhinitis Clinical Trial
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
NCT number | NCT01794741 |
Other study ID # | MP 4007 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | February 15, 2013 |
Last updated | March 22, 2015 |
Start date | February 2013 |
Verified date | March 2015 |
Source | Meda Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis
Status | Completed |
Enrollment | 405 |
Est. completion date | |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 11 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Clinical Research Center of Alabama,LLC | Birmingham | Alabama |
United States | Allergy and Asthma Specialist PC | Blue Bell | Pennsylvania |
United States | National Allergy, Asthna & Urticaria Centers of Charleston Pa | Charleston | Pennsylvania |
United States | Bernstein Clinical Research Center | Cincinnati | Ohio |
United States | Storms Clinical Research Institute | Colorado Springs | Colorado |
United States | West Coast Clinical Trials | Costa Mesa | California |
United States | AARA Research Center | Dallas | Texas |
United States | Texas Allergy Research Center | Dallas | Texas |
United States | Colorado Allergy and Asthma Centers, PC | Denver | Colorado |
United States | Idaho Allergy | Eagle | Idaho |
United States | ADAC Research, PA | Greenville | South Carolina |
United States | Clinical Research Institute of Indiana | Indianapolis | Indiana |
United States | Baker Allergy Asthma & Dermatology Ctr LLC | Lake Oswego | Oregon |
United States | Little Rock Allergy and Asthma Clinical research Center | Little Rock | Alaska |
United States | Allergy & Asthma Care Center of So. Cal | Long Beach | California |
United States | Family Allergy and Asthma Reserach | Louisville | Kentucky |
United States | Clinical Reseacrh Institute | Minneapolis | Minnesota |
United States | Southern California Research | Mission Viejo | California |
United States | Central Texas Health Research | New Braunfels | Texas |
United States | Sneeze, Wheeze and Itch Associates | Normal | Illinois |
United States | Allergy and Asthma Care of Florida | Ocala | Florida |
United States | Atlantic Research Center | Ocean | New Jersey |
United States | Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma |
United States | Oklahoma Institute of Allergy and Asthma | Oklahoma City | Oklahoma |
United States | Midwest Allergy and Asthma Clinic | Omaha | Nebraska |
United States | The Asthma and Allergy Center, PC | Papillion | Nebraska |
United States | Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania |
United States | Asthma and Allergy Associates, PC | Pueblo | Colorado |
United States | North Carolina Clinical Research | Raleigh | North Carolina |
United States | Live Oak Allergy and Asthma Clinic | San Antonio | Texas |
United States | Paul H Ratner,MD | San Antonio | Texas |
United States | Allergy Associates Medical Group Inc | San Diego | California |
United States | Allergy & Asthma Associates of Santa Clara Valley Research Cntr | San Jose | California |
United States | The Clinical Research Center | St. Louis | Missouri |
United States | Atlanta Allergy and Asthma Clinic | Stockbridge | Georgia |
United States | Asthma and Allergy Research Associate | Upland | Pennsylvania |
United States | Allergy Asthma Research Institute | Waco | Texas |
United States | Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco | Waco | Texas |
United States | Asthma, Sinus & Allergy Centers, LLC | Warren | New Jersey |
United States | Clinical Research of the Ozarks,Inc | Warrensburg | Missouri |
United States | Respiratory Medicine Research Institute of Michigan | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Meda Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events Report | reports of treatment emergent adverse events | 3 months of treatment | Yes |
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