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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dymista Nasal Spray

Fluticasone propionate nasal spray


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Meda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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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