A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies

Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis

The purpose of this study is to determine if two allergy medications are more effective than placebo.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: Placebo; Drug: 0.15% azelastine hydrochloride; Drug: 0.1% azelastine hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 581
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialist Medical Group
    • Long Beach, California, United States, 90806
      • Allergy, Asthma and Respiratory Care medical Center
    • Los Angeles, California, United States, 90025
      • Allergy Research Foundation
    • Mission Viejo, California, United States, 92691
      • Southern California Research
    • San Diego, California, United States, 92120
      • Allergy Associates Medical Group Inc
    • San Diego, California, United States, 92123
      • Allergy and Asthma Medical Group and Research Center
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clinical Research, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates
    • Colorodo Springs, Colorado, United States, 80907
      • The William Storms Allergy Clinic
  • Georgia
    • Woodstock, Georgia, United States, 30188
      • Atlanta Allergy and Asthma Clinic
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze and Itch Associates
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Kansas City Allergy and Asthma
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Institute for Asthma and Allergy PC
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • The Clinical Research Center
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Las Vegas Physicians Research Group
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Allergy and Asthma Research NJ inc
    • Ocean, New Jersey, United States, 07712
      • Atlantic Research Center
    • Teaneck, New Jersey, United States, 07666
      • Dr. Perin
  • New York
    • Rochester, New York, United States, 14618
      • AAIR Research Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center
    • Cincinnati, Ohio, United States, 45252
      • New Horizon's Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma and Clinical Research Center
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Allergy Asthma and Dermatology Research
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon, PC
  • Pennsylvania
    • Collegeville, Pennsylvania, United States, 19426
      • Allergy and Consultants of NJ/PA
    • Upland, Pennsylvania, United States, 19013
      • Asthma and Allergy Research Associate
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Asthma, Nasal Disease & Allergy Research Center of New England
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • National Allergy, Asthma and Urticaria of Charleston
  • Texas
    • Austin, Texas, United States, 78731
      • Allergy and Asthma Associates
    • Dallas, Texas, United States, 75231
      • AARA Research Center
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research & Consulting Inc
    • New Braunfels, Texas, United States, 78130
      • Central Texas Research
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Institute
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
    • Waco, Texas, United States, 76712
      • Allergy and Asthma Center
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Virginia Adult & Pediactric Allergy & Asthma, PC
  • Washington
    • Seattle, Washington, United States, 98105
      • ASTHMA, Inc.
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Advanced Healthcare, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients 12 years of age and older
• Must be in generally good health
• Must meet minimum symptom requirements, as specified in protocol
• Must be willing and able to provide informed consent and participate in all study procedures
• 2-year history of PAR
• Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion Criteria:

• On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
• Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
• Nasal surgery or sinus surgery within the previous year
• The use of any investigational drug within 30 days
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
• Women who are pregnant or nursing
• Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
• Respiratory tract infection within 2 weeks of screening
• Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
• Patients with asthma with the exception of mild, intermittent
• Significant pulmonary disease including COPD
• Patients with arrhythmia
• Patients with a known history of alcohol or drug abuse
• Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
• Clinically relevant abnormal physical findings within one week of randomization
• Overnight abscences from home for more than 3 nights
• Employees of the research center or private practice and family members are excluded
• Patients who received prohibited medications within specified timepoints in protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo	Drug: Placebo; Placebo
Experimental: 2; 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks	Drug: 0.15% azelastine hydrochloride; 0.15% azelastine hydrochloride 1644 mcg
Experimental: 3; 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks	Drug: 0.1% azelastine hydrochloride; 0.1% azelastine hydrochloride 1096 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.	baseline and 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days	instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.	baseline and 28 days
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days	Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.	baseline and 28 days
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days	A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.	baseline and 28 Days
Change From Baseline on Direct Visual Nasal Exams and 28 Days	Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation	baseline and 28 days

Collaborators and Investigators

• Sponsor: Meda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 9, 2008
• First Posted (Estimate): July 10, 2008

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 6, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Azelastine
• Other Study ID Numbers: MP434