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
1,791
1 country
45
Brief Summary
The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component 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 Apr 2009
Shorter than P25 for phase_3
45 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
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
September 7, 2012
CompletedJune 24, 2013
June 1, 2013
3 months
April 16, 2009
May 21, 2012
June 17, 2013
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 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.An greater negative value is suggestive of improvement.
day 1 to day 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 Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
day 1 to day 14
Study Arms (4)
placebo
PLACEBO COMPARATORazelastine Hcl
ACTIVE COMPARATORfluticasone propionate
ACTIVE COMPARATORazelastine Hcl /fluticasone propionate
EXPERIMENTALInterventions
azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg
Eligibility Criteria
You may qualify if:
- Male/female subjects 12 years of age and older
- Provide written informed consent/pediatric assent.
- Subjects must have moderate-to-severe rhinitis, with one or more of the following present:
- Sleep disturbance
- Impairment of daily activities, leisure and/or sport
- Impairment of school or work
- Troublesome symptoms
- Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Visit 1
- Randomization Visit: For the 3 days prior to Randomization and on the morning of Randomization, the sum of the 7 consecutive reflective AM and PM TNSS assessments shall be equal to or greater than 56, with a nasal congestion score equal to or greater than 14
- Randomization Visit: instantaneous TNSS score of at least 8 and a congestion score of at least 2 just prior to beginning the onset of action assessment
- Have taken at least 10 doses of the lead-in medication
- Willing and able to comply with the study requirements
- At least a 2-year history of SAR during the current allergy season
- The presence of IgE-mediated hypersensitivity to a prevailing, individual, seasonal pollen, confirmed by a positive response to skin prick within the last year.
- General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results.
- +2 more criteria
You may not qualify if:
- On Focused Nasal Examination, the presence of any superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study.
- Other nasal disease(s) likely to affect deposition of intranasal medication.
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis - more than 3 episodes per year
- Planned travel outside of the pollen area during the study period
- The use of any investigational drug within 30 days prior to Visit 1. No investigational products are permitted for use during the conduct of this study
- Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate
- Women who are pregnant or nursing
- Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception\* see section 6.1.1
- Respiratory Tract Infections within 14 days prior to Visit 1
- Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Visit 1
- Asthma (with the exception of intermittent asthma).
- Significant pulmonary disease including COPD
- Clinically significant arrhythmia or symptomatic cardiac conditions
- A known history of alcohol or drug abuse within the last 2 years
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, 85251, United States
Clinical Research Center
Encinitas, California, 92024, United States
AABI Associates Medical Group
Fountain Valley, California, 92708, United States
Allergy & Asthma Care Center of So. Cal
Long Beach, California, 90808, 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
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
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230, United States
Clinical Research Atlanta
Atlanta, Georgia, 30342, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761, United States
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210, United States
Family Allergy and Asthma Reserach
Louisville, Kentucky, 40215, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747, United States
Clinical Reseacrh Institute
Minneapolis, Minnesota, 55402, United States
The Clinical Research Center
St Louis, Missouri, 63141, United States
The Asthma and Allergy Center
Papillion, Nebraska, 68046, United States
Atlantic Research Center
Ocean City, New Jersey, 07712, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, 07059, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120, 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
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, 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
Pharmaceutical Research & Consulting Inc
Dallas, Texas, 75231, United States
Western Sky Medical Research
El Paso, Texas, 79902, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Diagnostic Research Group
San Antonio, Texas, 78229, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Allergy, Asthma Research Center
San Antonio, Texas, 78258, United States
Allergy and Asthma Center
Waco, Texas, 76712, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, 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,D.O.
- Organization
- Meda Pharmaceuticals, Inc.
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
April 16, 2009
First Posted
April 17, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
June 24, 2013
Results First Posted
September 7, 2012
Record last verified: 2013-06