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
1 other identifier
interventional
581
1 country
43
Brief Summary
The purpose of this study is to determine if two allergy medications are more effective than placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
43 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
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 8, 2008
CompletedFirst Posted
Study publicly available on registry
July 10, 2008
CompletedResults Posted
Study results publicly available
January 15, 2010
CompletedJune 8, 2011
June 1, 2011
1.3 years
July 8, 2008
September 30, 2009
June 6, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days
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
baseline and 28 days
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
baseline and 28 Days
Change From Baseline on Direct Visual Nasal Exams and 28 Days
baseline and 28 days
Study Arms (3)
1
PLACEBO COMPARATORPlacebo
2
EXPERIMENTAL0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks
3
EXPERIMENTAL0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
- year history of PAR
- Positive skin test to cockroach, dust mite, mold or cat/dog dander
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, 92647, United States
Allergy, Asthma and Respiratory Care medical Center
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 and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, 80907, United States
The William Storms Allergy Clinic
Colorodo Springs, Colorado, 80907, United States
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, 30188, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761, United States
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210, 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
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
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
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 Consultants of NJ/PA
Collegeville, Pennsylvania, 19426, 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
Central Texas 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
Allergy and Asthma Center
Waco, Texas, 76712, United States
Virginia Adult & Pediactric Allergy & Asthma, PC
Richmond, Virginia, 23229, United States
Asthma, Inc.
Seattle, Washington, 98105, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Ramalingam RK, Canonica GW, Berger WE. A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis. Front Allergy. 2023 Oct 18;4:1244012. doi: 10.3389/falgy.2023.1244012. eCollection 2023.
PMID: 37920410DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Standard deviations for primary endpoint are not available.
Results Point of Contact
- Title
- William Wheeler, PhD
- Organization
- 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 8, 2008
First Posted
July 10, 2008
Study Start
January 1, 2007
Primary Completion
May 1, 2008
Last Updated
June 8, 2011
Results First Posted
January 15, 2010
Record last verified: 2011-06