A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis

The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 703
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Oxford, Alabama, United States, 36203
      • Center of Research Excellence, LLC
  • California
    • Fountain Valley, California, United States, 92708
      • AABI Associates Medical Group
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialist Medical Group
    • Long Beach, California, United States, 90806
      • West Coast Clinical Trials
    • 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
    • San Jose, California, United States, 95117
      • Allergy & Asthma Associates of Santa Clara Valley Research Cntr
    • Stockton, California, United States, 95207
      • Bensch Research Associates
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clinical Research, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates
  • Florida
    • Ocala, Florida, United States, 34471
      • Allergy and Asthma Care of Florida
    • Tallahassee, Florida, United States, 32308
      • Allergy and Asthma DTC
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens Clinical Research Centers Inc
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Laboratories of Savannah
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze and Itch Associates
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Kansas City Allergy and Asthma
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • RX R+D
  • 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
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • The Asthma and Allergy 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
    • North Syracuse, New York, United States, 13212
      • Medical Research Associates of CNY, PLLC
    • 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
    • Edmond, Oklahoma, United States, 73003
      • Oklahoma Institute of Allergy and Asthma Clinical
    • 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
    • Blue Bell, Pennsylvania, United States, 19422
      • Allergy and Asthma Specialist PC
    • Collegeville, Pennsylvania, United States, 19426
      • Allergy and Consultants of NJ/PA
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
    • 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
    • El Paso, Texas, United States, 79902
      • Western Sky Medical Research
    • Houston, Texas, United States, 77074
      • SWAAA Research Center
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Institute
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
    • San Antonio, Texas, United States, 78233
      • Live Oak Allergy and Asthma Clinic
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
  • Virginia
    • Richmond, Virginia, United States, 23229
      • VA Adult and Pediatric Allergy and Asthma
  • Washington
    • Seattle, Washington, United States, 98105
      • ASTHMA, Inc.
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Advanced Healthcare

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 and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
• Must be willing and able to provide informed consent and to participate in all study procedures
• Must be in generally good health
• Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

• On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
• Use of any investigational drug within 30 days of the first visit
• Any nasal surgery or sinus surgery within the previous year
• Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
• Women who are pregnant or nursing
• Women who are not using an acceptable method of birth control
• Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
• Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
• Patients with Arrythmia
• Patients with know history of alcohol and drug abuse
• Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
• Use of medications that could affect the study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 0.15% azelastine hydrochloride 1644 mcg	Drug: 0.15% azelastine hydrochloride; 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Experimental: 2; Mometasone furoate 200 mcg	Drug: Mometasone furoate; 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline on Direct Visual Nasal Exams to 12 Months	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 irritation 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	Change from baseline to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older	A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. 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.	change from baseline to 12 months

Collaborators and Investigators

• Sponsor: Meda Pharmaceuticals
• Investigators: Study Director: Lewis M. Fredane, MD, Meda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: May 1, 2015

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; Anti-Inflammatory Agents; Dermatologic Agents; 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; Mometasone Furoate; Azelastine
• Other Study ID Numbers: MP436