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
1 other identifier
interventional
703
1 country
59
Brief Summary
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2007
Shorter than P25 for phase_3
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 21, 2008
CompletedFirst Posted
Study publicly available on registry
July 22, 2008
CompletedResults Posted
Study results publicly available
January 15, 2010
CompletedMay 21, 2015
May 1, 2015
1.3 years
July 21, 2008
November 6, 2009
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
change from baseline to 12 months
Study Arms (2)
1
EXPERIMENTAL0.15% azelastine hydrochloride 1644 mcg
2
EXPERIMENTALMometasone furoate 200 mcg
Interventions
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Center of Research Excellence, LLC
Oxford, Alabama, 36203, United States
AABI Associates Medical Group
Fountain Valley, California, 92708, United States
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, 92647, United States
West Coast Clinical Trials
Long Beach, California, 90806, United States
Allergy Research Foundation
Los Angeles, California, 90025, United States
Southern California Research
Mission Viejo, California, 92691, United States
Allergy Associates Medical Group Inc
San Diego, California, 92120, 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
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, 80907, United States
Allergy and Asthma Care of Florida
Ocala, Florida, 34471, United States
Allergy and Asthma DTC
Tallahassee, Florida, 32308, United States
Georgia Pollens Clinical Research Centers Inc
Albany, Georgia, 31707, United States
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761, United States
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210, United States
RX R+D
Metairie, Louisiana, 70001, United States
Institute for Asthma and Allergy PC
Wheaton, Maryland, 20902, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
The Clinical Research Center
St Louis, Missouri, 63141, United States
The Asthma and Allergy Center
Papillion, Nebraska, 68046, United States
Las Vegas Physicians Research Group
Henderson, Nevada, 89052, United States
Allergy and Asthma Research NJ inc
Mount Laurel, New Jersey, 08054, United States
Atlantic Research Center
Ocean City, New Jersey, 07712, United States
Dr. Perin
Teaneck, New Jersey, 07666, United States
Medical Research Associates of CNY, PLLC
North Syracuse, New York, 13212, United States
AAIR Research Center
Rochester, New York, 14618, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
New Horizon's Clinical Research
Cincinnati, Ohio, 45252, United States
Oklahoma Institute of Allergy and Asthma Clinical
Edmond, Oklahoma, 73003, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, 97035, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Allergy and Asthma Specialist PC
Blue Bell, Pennsylvania, 19422, United States
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, 19426, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
Asthma and Allergy Research Associate
Upland, Pennsylvania, 19013, United States
Asthma, Nasal Disease & Allergy Research Center of New England
Providence, Rhode Island, 02906, United States
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, 29407, United States
Allergy and Asthma Associates
Austin, Texas, 78731, United States
AARA Research Center
Dallas, Texas, 75231, United States
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231, United States
Western Sky Medical Research
El Paso, Texas, 79902, United States
SWAAA Research Center
Houston, Texas, 77074, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Biogenics Research Institute
San Antonio, Texas, 78229, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, United States
VA Adult and Pediatric Allergy and Asthma
Richmond, Virginia, 23229, United States
Asthma, Inc.
Seattle, Washington, 98105, United States
Advanced Healthcare
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Kumar Ramalingam R, Canonica GW, Berger WE. In perennial allergic rhinitis, RQLQ is improved similarly by Azelastine 0.15 and mometasone furoate. World Allergy Organ J. 2025 Jan 8;18(1):101021. doi: 10.1016/j.waojou.2024.101021. eCollection 2025 Jan.
PMID: 39885937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- William Wheeler, PhD
- Organization
- Meda Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Lewis M. Fredane, MD
Meda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2008
First Posted
July 22, 2008
Study Start
March 1, 2007
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
May 21, 2015
Results First Posted
January 15, 2010
Record last verified: 2015-05