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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01915823
First received: August 1, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: azelastine hydrochloride and fluticasone propionate
Drug: Dymista vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • primary efficacy [ Time Frame: 15 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: entire length of study (day 1 to day 22) ] [ Designated as safety issue: Yes ]
    • Subject-reported adverse experiences (incidence, type, and severity of adverse events)
    • Nasal Examinations
    • Vital signs assessments


Other Outcome Measures:
  • Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) [ Time Frame: day 1 to day 15 of treatment ] [ Designated as safety issue: No ]
    Change from baseline to Visits 3 and 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects ≥6 years of age


Enrollment: 348
Study Start Date: July 2013
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Dymista
Placebo Comparator: Dymista vehicle
Dose: vehicle only Regimen: 1 spray per nostril twice daily
Drug: Dymista vehicle
Other Name: placebo

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915823

  Show 31 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01915823     History of Changes
Other Study ID Numbers: MP 4008
Study First Received: August 1, 2013
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Rhinitis
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Azelastine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on September 18, 2014