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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


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 Placebo

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

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)


Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.


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


- 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


- 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

Page last updated: August 23, 2015

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