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

Completed · Phase 3 · Has a placebo group

Conditions studied: Perennial Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT01018862

Run by

Meda Pharmaceuticals

People needed

489

Starts

2009-11-01

Expected to finish

2011-04-01

Last updated by the study team

2012-06-11

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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