Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)

Randomized, Double-Blind Trial of the Safety and Efficacy of Dymista Nasal Spray Compared to Placebo Nasal Spray in the Treatment of Children Ages >4 Years to <12 Years With Seasonal Allergic Rhinitis

The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: azelastine hydrochloride and fluticasone propionate; Drug: Dymista vehicle

• Study Type: Interventional
• Enrollment (Actual): 348
• Phase: Phase 3

Contacts and Locations

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
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Clinical Research Atlanta
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Laboratories of Savannah
    • Stockbridge, Georgia, United States, 30281
      • Atlanta Allergy and Asthma Clinic
  • 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
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Institute for Asthma and Allergy PC
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan
  • Minnesota
    • Plymouth, Minnesota, United States, 55402
      • Clinical Research Institute
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • The Clinical Research Center
    • Warrensburg, Missouri, United States, 64093
      • Clinical Research of the Ozarks,Inc
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Allergy and Asthma Research NJ inc
    • Ocean, New Jersey, United States, 07712
      • Atlantic Research Center
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research
  • 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
  • Pennsylvania
    • Blue Bell, Pennsylvania, United States, 19422
      • Allergy and Asthma Specialist PC
    • Upland, Pennsylvania, United States, 19013
      • Asthma and Allergy Research Associate
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • National Allergy, Asthma and Urticaria of Charleston
    • Charleston, South Carolina, United States, 29414
      • Allergy and Asthma Consultants, LLP
  • Texas
    • Ausitn, Texas, United States, 78731
      • ISIS Clinical Research, LLC
    • Austin, Texas, United States, 78759
      • Sirius Clinical Research
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
    • San Antonio, Texas, United States, 78233
      • Live Oak Allergy and Asthma Clinic
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
    • Waco, Texas, United States, 76712
      • Immunology/allergy and asthma Care of Waco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects ages >4 years to <12 years of age, inclusive at the screening visit
• The parent/caregiver must provide written informed consent and the child must provide pediatric assent, if possible
• Willing and able to comply with the study requirements
• Have a history of seasonal allergic rhinitis (SAR) to pollen in the prevailing allergy season.
• The presence of immunoglobulin E (IgE)-mediated hypersensitivity to prevailing pollen, confirmed by a positive response to skin prick test. A histamine skin test must also be positive. A positive response for both the pollen skin test and the histamine skin test is defined as a wheal diameter of at least 4 mm larger than the negative saline control
• 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
• On the first day of the placebo lead-in period (Visit 1) subjects must have a 12-hour reflective total nasal symptoms score (rTNSS )of ≥6 and a reflective congestion score of ≥2 to qualify for entry.

At Visit 2:

• Have taken at least 6 doses of the placebo lead-in medication during the placebo lead-in period

• At Visit 2, to be eligible for entry into the double-blind treatment period, subjects must have the total of the seven lead-in symptom assessments during the past 3 days of the lead-in period including the Day of Randomization (Visit 2, Day 1):

  • a 12-hour reflective TNSS ≥ 42
  • a 12-hour reflective congestion score of ≥14

Exclusion Criteria:

• On nasal examination, the presence of any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1B - 4) at either the screening visit or randomization visit
• 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 signing the informed consent/pediatric assent at 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 14 days prior to Visit1
• 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 that might significantly affect the subject's ability to complete this trial
• Clinically relevant abnormal physical findings which, in the opinion of the investigator or sponsor's medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures
• Family members of the research center or private practice personnel who are directly involved in this study are excluded
• Members of the same household cannot be enrolled at the same time
• Subjects who have used medications or therapies that could interfere with safety and efficacy evaluations 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
• Females of childbearing potential who are not abstinent and not 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
• 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 regimens following a brief period of missed injections do not preclude participation). Dose reduction when a new bottle is used does not preclude participation.
• Planned travel outside of the pollen area during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dymista; (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily	Drug: azelastine hydrochloride and fluticasone propionate; Other Names: Dymista
PLACEBO_COMPARATOR: Dymista vehicle; Dose: vehicle only Regimen: 1 spray per nostril twice daily	Drug: Dymista vehicle; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy	change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.	15 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Subject-reported adverse experiences (incidence, type, and severity of adverse events); Nasal Examinations; Vital signs assessments	entire length of study (day 1 to day 22)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)	Change from baseline to Visit 4 in the ITT ( intent to treat) Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects equal to or greater than 6 years old and less than12 years old compared to placebo.Scored on a 0 to 7 scale with 0 being not troubled at all and 7 being extremely troublesome. The higher the difference the better the result.	day 1 to day 15 of treatment

Collaborators and Investigators

• Sponsor: Meda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (ESTIMATE): August 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 29, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Fluticasone; Xhance; Azelastine
• Other Study ID Numbers: MP 4008