A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis
Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Perennial Allergic Rhinitis
Intervention: Azelastine hydrochloride nasal spray 0.15% (Drug); Azelastine hydrochloride nasal spray 0.10% (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Meda Pharmaceuticals Official(s) and/or principal investigator(s): David Ginsberg, DO, Study Director, Affiliation: Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
Secondary outcome: Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to PlaceboChange 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 Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo
Detailed description:
in Children Ages >6 to <12 with Perennial Allergic Rhinitis (PAR)
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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:
1. 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:
1. a 12-hour reflective TNSS ≥ 6
2. a 12-hour reflective congestion score of ≥2 or a rhinorrhea score of ≥2
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):
1. a 12-hour reflective TNSS ≥ 42
2. 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
- 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). Subjects receiving sublingual immunotherapy are excluded. A 6 month
washout period is required following the last dose of sublingual immunotherapy.
Exclusion Criteria:
- 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
- Members of the same family cannot enroll in the study at the same time
- Subjects who have used the medications or therapies that could interfere with symptom
evaluation within the time period specified (see Section 4. 0).
- 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
Locations and Contacts
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, New Jersey 07059, United States
Island Medical Research, Rockville Center, 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
Additional Information
Starting date: November 2009
Last updated: May 10, 2012
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