A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 (0.15% Solution) and MP03-33 (0.10% Solution) in Children Ages >6 to <12 With Perennial Allergic Rhinitis
1 other identifier
interventional
489
1 country
39
Brief Summary
The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2009
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
June 11, 2012
CompletedJune 11, 2012
May 1, 2012
1.4 years
November 24, 2009
March 22, 2012
May 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
baseline to 28 Days
Secondary Outcomes (3)
Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
baseline to 28 days
Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo
baseline to 28 days
Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo
baseline to 28 Days
Study Arms (3)
MP03-36 (0.15% solution)
ACTIVE COMPARATOR822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
MP03-33 (0.10% solution)
ACTIVE COMPARATOR548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Placebo
PLACEBO COMPARATOR0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Interventions
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Eligibility Criteria
You may qualify if:
- Male and female subjects \>6-\<12, inclusive at the screening visit
- At least a 1-year history of PAR
- The parent must provide written informed consent and the child must provide written assent.
- Willing and able to comply with the study requirements
- The presence of immunoglobulin E (IgE)-mediated hypersensitivity to dust mite, cockroach, mold, cat or dog dander, confirmed by a positive response to skin prick testing at the Visit 1. A positive response is defined as a wheal diameter of ≥5 mm larger than the negative control for the skin prick test. Histamine control must also be positive with a wheal diameter \>5 mm larger than the control. If there are prevailing seasonal allergies, the subject must have a negative skin test to the specific allergen.
- Screening Visit: Have a 12-hour reflective TNSS of at least 6 out of a possible 12 and a congestion score of ≥2 or a rhinorrhea score of ≥2 on Visit 1
- Randomization Visit: to be eligible for entry into the double-blind treatment period, subjects/caregivers must record:
- at least 3 symptom assessments (either AM or PM score) during the past 3 days of the Lead-In Period or the Day of Randomization:
- a 12-hour reflective TNSS ≥ 6
- a 12-hour reflective congestion score of ≥2 or a rhinorrhea score of ≥2
- 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 or a rhinorrhea score of ≥14
- Must have taken at least 10 doses of study medication during the placebo Lead-In Period
- 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
- +1 more criteria
You may not qualify if:
- On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation (Grade 1B - 4) (see section 8.1.4).
- Other nasal disease(s) likely to affect deposition of intranasal medication, such as acute sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities.
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis
- 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 drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
- Females who are pregnant or nursing
- Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- 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 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 within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
- Overnight absences from home for more than 3 nights
- Family members of research center or private practice personnel who are directly involved in this study are excluded
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
West Coast Clinical Trials
Costa Mesa, California, 92626, United States
Allergy, Asthma and Respiratory Care Center
Long Beach, California, 90806, United States
Southern California Research
Mission Viejo, California, 92691, United States
Joann Blessing-Moore,MD
Palo Alto, California, 94304, United States
Capital Allergy and Respiratory Disease Center
Sacramento, California, 95819, United States
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123, United States
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
San Jose, California, 95117, United States
Bensch Research Associates
Stockton, California, 95207, United States
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230, United States
Center for Allergy, Asthma and Immunology
Waterbury, Connecticut, 06708, United States
Clinical Research Atlanta
Atlanta, Georgia, 30342, United States
Idaho Allergy
Eagle, Idaho, 83616, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761, United States
Clinical Research Institute of Indiana
Indianapolis, Indiana, 46208, United States
Chesapeake Clinical Research, Inc
Baltimore, Maryland, 21236, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197, United States
Clinical Research Institute
Plymouth, Minnesota, 55402, United States
Asthma and Allergy Center, PC
Papillion, Nebraska, 68046, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Asthma, Sinus & Allergy Centers, LLC
Warren Township, New Jersey, 07059, United States
Island Medical Research
Rockville Centre, New York, 11570, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Institute of Allergy and Asthma
Oklahoma City, Oklahoma, 73131, United States
Baker Asthma, Allergy and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035, United States
Allergy Associated Research Center
Portland, Oregon, 97213, United States
Allergy and Asthma Consultants of NJ-PA, P.C
Collegeville, Pennsylvania, 19426, United States
Allergy and Asthma Consultants, LLP
Charleston, South Carolina, 29414, United States
Isis Clinical Research, LLC
Ausitn, Texas, 78731, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Sirius Clinical Research
Austin, Texas, 78759, United States
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231, United States
Western Sky Medical Research
El Paso, Texas, 79902, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Intermountain Clinical Research
Draper, Utah, 84020, United States
Marycliff Allergy Specialists
Spokane, Washington, 99204, United States
Gary Steven, MD
Greenfield, Wisconsin, 53228, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr.Director Medical Scientific Affairs
- Organization
- Meda Pharmaceuticals Inc
Study Officials
- STUDY DIRECTOR
David Ginsberg, DO
Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 11, 2012
Results First Posted
June 11, 2012
Record last verified: 2012-05