3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis

March 22, 2015 updated by: Meda Pharmaceuticals

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
405

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Center of Alabama,LLC
    • Alaska
      • Little Rock, Alaska, United States, 72205
        • Little Rock Allergy and Asthma Clinical Research Center
    • California
      • Costa Mesa, California, United States, 92626
        • West Coast Clinical Trials
      • Long Beach, California, United States, 90808
        • Allergy & Asthma Care Center of So. Cal
      • Mission Viejo, California, United States, 92691
        • Southern California Research
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group Inc
      • San Jose, California, United States, 95117
        • Allergy & Asthma Associates of Santa Clara Valley Research Cntr
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Storms Clinical Research Institute
      • Denver, Colorado, United States, 80230
        • Colorado Allergy and Asthma Centers, PC
      • Pueblo, Colorado, United States, 81001
        • Asthma and Allergy Associates, PC
    • Florida
      • Ocala, Florida, United States, 34471
        • Allergy and Asthma Care of Florida
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Atlanta Allergy and Asthma Clinic
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Idaho Allergy
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze and Itch Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Clinical Research Institute of Indiana
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Family Allergy and Asthma Reserach
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Research Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Reseacrh Institute
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • The Clinical Research Center
      • Warrensburg, Missouri, United States, 64093
        • Clinical Research of the Ozarks,Inc
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Midwest Allergy and Asthma Clinic
      • Papillion, Nebraska, United States, 68046
        • The Asthma and Allergy Center, PC
    • New Jersey
      • Ocean, New Jersey, United States, 07712
        • Atlantic Research Center
      • Warren, New Jersey, United States, 07059
        • Asthma, Sinus & Allergy Centers, LLC
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma & Clinical Research Center
      • Oklahoma City, Oklahoma, United States, 73131
        • Oklahoma Institute of Allergy and Asthma
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Baker Allergy Asthma & Dermatology Ctr LLC
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • Allergy and Asthma Specialist PC
      • Charleston, Pennsylvania, United States, 29406
        • National Allergy, Asthna & Urticaria Centers of Charleston Pa
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
      • Upland, Pennsylvania, United States, 19013
        • Asthma and Allergy Research Associate
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • ADAC research, PA
    • Texas
      • Dallas, Texas, United States, 75231
        • AARA Research Center
      • Dallas, Texas, United States, 75246
        • Texas Allergy Research Center
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
      • San Antonio, Texas, United States, 78233
        • Live Oak Allergy and Asthma Clinic
      • San Antonio, Texas, United States, 78229
        • Paul H Ratner,MD
      • Waco, Texas, United States, 76712
        • Allergy Asthma Research Institute
      • Waco, Texas, United States, 76712
        • Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 months to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dymista nasal spray
azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months
Drug: Dymista Nasal Spray
Active Comparator: fluticasone propionate nasal spray
fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Drug: Fluticasone propionate nasal spray

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events Report
Time Frame: 3 months of treatment
reports of treatment emergent adverse events
3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meda Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nancy Ruiz, M.D., Sponsor GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP 4007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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