A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis

NCT ID: NCT01018862

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 489 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-04-30

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.

Detailed Description

in Children Ages >6 to <12 with Perennial Allergic Rhinitis (PAR)

Conditions

Perennial Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MP03-36 (0.15% solution)

822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Group Type: ACTIVE_COMPARATOR

Azelastine hydrochloride nasal spray 0.15%

Intervention Type: DRUG

822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

MP03-33 (0.10% solution)

548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Group Type: ACTIVE_COMPARATOR

Azelastine hydrochloride nasal spray 0.10%

Intervention Type: DRUG

548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Placebo

0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Interventions

Azelastine hydrochloride nasal spray 0.15%

822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Intervention Type: DRUG

Azelastine hydrochloride nasal spray 0.10%

548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Intervention Type: DRUG

Placebo

0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Intervention Type: DRUG

Other Intervention Names

Astepro 0.15%; Astepro 0.10%

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meda Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ginsberg, DO

Role: STUDY_DIRECTOR

Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs

Locations

West Coast Clinical Trials

Costa Mesa, California, United States

Allergy, Asthma and Respiratory Care Center

Long Beach, California, United States

Southern California Research

Mission Viejo, California, United States

Joann Blessing-Moore,MD

Palo Alto, California, United States

Capital Allergy and Respiratory Disease Center

Sacramento, California, United States

Allergy and Asthma Medical Group and Research Center

San Diego, California, United States

Allergy & Asthma Associates of Santa Clara Valley Research Cntr

San Jose, California, United States

Bensch Research Associates

Stockton, California, United States

Colorado Allergy and Asthma Centers, PC

Denver, Colorado, United States

Center for Allergy, Asthma and Immunology

Waterbury, Connecticut, United States

Clinical Research Atlanta

Atlanta, Georgia, United States

Idaho Allergy

Eagle, Idaho, United States

Sneeze, Wheeze and Itch Associates

Normal, Illinois, United States

Clinical Research Institute of Indiana

Indianapolis, Indiana, United States

Chesapeake Clinical Research, Inc

Baltimore, Maryland, United States

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, United States

Clinical Research Institute

Plymouth, Minnesota, United States

Asthma and Allergy Center, PC

Papillion, Nebraska, United States

Princeton Center for Clinical Research

Skillman, New Jersey, United States

Asthma, Sinus & Allergy Centers, LLC

Warren Township, New Jersey, United States

Island Medical Research

Rockville Centre, New York, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Toledo Center for Clinical Research

Sylvania, Ohio, United States

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Oklahoma Institute of Allergy and Asthma

Oklahoma City, Oklahoma, United States

Baker Asthma, Allergy and Dermatology Research Center, LLC

Lake Oswego, Oregon, United States

Allergy Associated Research Center

Portland, Oregon, United States

Allergy and Asthma Consultants of NJ-PA, P.C

Collegeville, Pennsylvania, United States

Allergy and Asthma Consultants, LLP

Charleston, South Carolina, United States

Isis Clinical Research, LLC

Ausitn, Texas, United States

Central Texas Clinical Research

Austin, Texas, United States

Sirius Clinical Research

Austin, Texas, United States

Pharmaceutical Research & Consulting Inc

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Sylvana Research Associates

San Antonio, Texas, United States

Intermountain Clinical Research

Draper, Utah, United States

Marycliff Allergy Specialists

Spokane, Washington, United States

Gary Steven, MD

Greenfield, Wisconsin, United States

Countries

United States

Other Identifiers

MP441

Identifier Type: -

Identifier Source: org_study_id