A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
1 other identifier
interventional
832
1 country
43
Brief Summary
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
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 2008
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 2, 2008
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
CompletedResults Posted
Study results publicly available
September 26, 2012
CompletedSeptember 26, 2012
August 1, 2012
3 months
March 28, 2008
May 10, 2012
August 27, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)
change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.
days 1 to 14
Secondary Outcomes (2)
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
day 1 to day 14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days
day 1 to day 14
Study Arms (4)
fluticasone propionate
ACTIVE COMPARATORazelastineHcl/fluticasone propionate
EXPERIMENTALPlacebo
PLACEBO COMPARATORazelastine Hcl
ACTIVE COMPARATORInterventions
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
fluticasone propionate 200 mcg
Eligibility Criteria
You may qualify if:
- Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in the protocol
- Must be wiling and able to provide informed consent and to participate all study procedures
- Positive skin test to a prevalent spring allergen
You may not qualify if:
- On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
- Nasal or sinus surgery within the previous 6 months
- Chronic sinus infection (more than 3 per year)
- Planned travel outside the study area during the study period
- Use of any investigational drug within 30 days of the first visit
- Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
- Women who are not using an acceptable method or birth control
- Women who are pregnant or nursing
- Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
- Irregular heartbeat or other symptomatic heart conditions
- History of alcohol or drug abuse
- History of glaucoma
- Use of medications that could affect the study results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, 85251, United States
Clinical Research Center
Encinitas, California, 92024, United States
Allergy Research Foundation
Los Angeles, California, 90025, United States
Southern California Research
Mission Viejo, California, 92691, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123, United States
Bensch Research Associates
Stockton, California, 95207, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230, United States
Colorado Allergy and Asthma Centers
Lakewood, Colorado, 80401, United States
Clinical Research Atlanta
Atlanta, Georgia, 30342, 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
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
Allergy, Asthma and Immunology Associates
Lincoln, Nebraska, 68505, United States
The Asthma and Allergy Center
Papillion, Nebraska, 68046, United States
Atlantic Research Center
Ocean City, New Jersey, 07712, United States
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, 07059, United States
AAIR Research Center
Rochester, New York, 14618, United States
Island Medical Research
Rockville Centre, New York, 11570, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
Allergy Clinic of Tulsa
Tulsa, Oklahoma, 74133, United States
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, 97035, 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
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, 29407, United States
East Tennesse Center for Clinical Research
Knoxville, Tennessee, 37909, United States
Allergy and Asthma Associates
Austin, Texas, 78731, United States
Allergy and Asthma Center of Austin
Austin, Texas, 78759, United States
AARA Research Center
Dallas, Texas, 75231, United States
Jane Lee, MD, PA Research Center
Dallas, Texas, 75246, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Intermountain Clinical Research
Draper, Utah, 84020, United States
Asthma, Inc.
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Ginsberg,..
- Organization
- Meda Pharmaceutical
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 2, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
September 26, 2012
Results First Posted
September 26, 2012
Record last verified: 2012-08