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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915823
• Other study ID #: MP 4008
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2013
• Last updated: June 9, 2015
• Start date: July 2013

Study information

• Verified date: June 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• azelastine hydrochloride and fluticasone propionate

• Dymista vehicle

Locations

Country	Name	City	State
United States	Clinical Research Atlanta	Atlanta	Georgia
United States	Isis Clinical Research, LLC	Ausitn	Texas
United States	Sirius Clinical Research	Austin	Texas
United States	Clinical Research Center of Alabama,LLC	Birmingham	Alabama
United States	Allergy and Asthma Specialist PC	Blue Bell	Pennsylvania
United States	Allergy and Asthma Consultants, LLP	Charleston	South Carolina
United States	National Allergy, Asthma and Urticaria of Charleston	Charleston	South Carolina
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Clinical Research Institute of Indiana	Indianapolis	Indiana
United States	Little Rock Allergy and Asthma Clinical research Center	Little Rock	Alaska
United States	Family Allergy and Asthma Reserach	Louisville	Kentucky
United States	Allergy and Asthma Research NJ inc	Mount Laurel	New Jersey
United States	Central Texas Health Research	New Braunfels	Texas
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
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	Clinical Research Institute	Plymouth	Minnesota
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Live Oak Allergy and Asthma Clinic	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Aeroallergy Research Laboratories of Savannah	Savannah	Georgia
United States	Princeton Center for Clinical Research	Skillman	New Jersey
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	Immunology/allergy and asthma Care of Waco	Waco	Texas
United States	Clinical Research of the Ozarks,Inc	Warrensburg	Missouri
United States	Institute for Asthma and Allergy PC	Wheaton	Maryland
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
Other	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	No
Primary	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	No
Secondary	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)	Yes