A Study Evaluating 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
776
1 country
39
Brief Summary
The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) 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 Aug 2008
Shorter than P25 for phase_3
39 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
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
September 7, 2012
CompletedSeptember 7, 2012
August 1, 2012
3 months
August 22, 2008
May 15, 2012
August 7, 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 you felt over the previous 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.A greater negative score is suggestive of improvement.
day1 to 14 days
Secondary Outcomes (2)
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
day 1 to14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
day 1 to day 14
Study Arms (4)
azelastine HCl/fluticasone propionate
EXPERIMENTALnasal spray
azelastine HCL
ACTIVE COMPARATORnasal spray
fluticasone propionate
ACTIVE COMPARATORnasal spray
placebo
PLACEBO COMPARATORnasal spray
Interventions
azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID
azelastine Hcl 548 mcg one spray per nostril BID
fluticasone propionate 200 mcg one spray per nostril BID
Eligibility Criteria
You may qualify if:
- Male and female subjects 12 years of age and older
- Provide written informed consent/pediatric assent. If the subject is a minor, parent or legal guardian must give written informed consent
- Subjects must have moderate-to-severe rhinitis, defined as having one or more of the following:
- 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 of 12 and a congestion score of 2 or 3 on Visit 1
- Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period.
- Randomization Visit: Have an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) Randomization Visit: Have an instantaneous TNSS score of 8 or more at time point zero, 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 requirementsAt least a 2-year history of SAR during Fall allergy season
- The presence of IgE-mediated hypersensitivity to a local Fall pollen, confirmed by a positive response to skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control.
- General good health and free of disease or concomitant treatment that could interfere with the interpretation of the study results
- Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit
- +1 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 at either the screening visit or randomization visit
- 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 Day -7.
- 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\*
- Respiratory Tract Infections within 14 days prior to Day -7
- Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Day -7
- 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 (39)
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
William Ebbling, MD Inc
Fresno, California, 93720, 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
Bensch Research Associates
Stockton, California, 95207, 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
Atlanta Allergy and Asthma Clinic
Stockbridge, Georgia, 30281, 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 Reseacrh 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
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 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
Southwest Allergy and Asthma Center, P.A.
San Antonio, Texas, 78229, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Intermountain Clinical Research
Draper, Utah, 84020, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Ginsberg,D.O.
- 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
- 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
August 22, 2008
First Posted
August 25, 2008
Study Start
August 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
September 7, 2012
Results First Posted
September 7, 2012
Record last verified: 2012-08