A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis
1 other identifier
interventional
617
1 country
30
Brief Summary
The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.
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 2006
30 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, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 6, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedOctober 6, 2011
October 1, 2011
3 months
June 6, 2011
October 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo
14 Days
Secondary Outcomes (3)
Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo
14 Days
Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo
14 Days
Change From Baseline on Direct Visual Nasal Exams
14 Days
Study Arms (4)
MP03-36 Nasal Spray
ACTIVE COMPARATORazelastine hydrochloride 0.15%
MP03-36 and Placebo Nasal Spray
ACTIVE COMPARATORazelastine hydrochloride 0.15% and Placebo
Azelastine 0.1%, Nasal Spray
ACTIVE COMPARATORAzelastine 0.1%, Nasal Spray
Placebo Nasal Sapray
PLACEBO COMPARATOR0mg, 2 sprays per nostril twice daily AM \& PM)
Interventions
1644 mcg, 2 sprays per nostril twice daily AM \& PM)
822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM \& PM)
Eligibility Criteria
You may qualify if:
- Male and female patients 12 years of age and older
- Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
- Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
- Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM or PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).
- Must have taken at least 10 doses of study medication during the lead-in period
- Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of action assessment on Day 1
- Willing and able to comply with the study requirements
- At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen allergy season
- The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test.
- General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
- Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee.
You may not qualify if:
- The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
- Women who are pregnant or nursing
- Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- Respiratory tract infections within two weeks prior to Day -7
- Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7
- Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
- Patients with asthma (with the exception of mild, intermittent asthma)
- Patients with significant pulmonary disease
- 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, might significantly alter the absorption, distribution, metabolism, or excretion of study drug
- Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
- Planned travel outside the study area during the study period
- Family members and employees should be excluded
- Patients who received prohibited medications within specified timepoints in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
AABI Associates Medical Group
Fountain Valley, California, 92708, 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 Medical Group
Roseville, California, 95678, United States
Allergy Associates Medical Group
San Diego, California, 92120, United States
Allergy and Asthma Associates of CA
San Jose, California, 95117, United States
The William Storms Allergy Clinic
Colorado Springs, Colorado, 80907, United States
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230, United States
Coastal Allergy and Asthma P.C.
Savannah, Georgia, 31406, United States
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210, United States
Institute for Asthma and Allergy, P.C.
Wheaton, Maryland, 20902, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
The Asthma and Allergy Center, PC
Papillion, Nebraska, 68046, United States
Atlantic Allergy, Asthma & Immunology
Ocean City, New Jersey, 07712, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Allergy and Asthma Institue of Rochester
Rochester, New York, 14618, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Clinical Research Center
Cincinnati, Ohio, 45231, United States
Oklahoma Institute of Allergy and Asthma
Edmond, Oklahoma, 73003, United States
Allergy and Asthma Consultants of NJ-PA, P.C
Collegeville, Pennsylvania, 19426, United States
Valley Clinical Research Center
Easton, Pennsylvania, 18045, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
Allergy Asthma Associates Research Dept.
Austin, Texas, 78731, United States
AARA Research Center
Dallas, Texas, 75231, United States
Research Across America
Dallas, Texas, 75234, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Allergy and Asthma Center
Waco, Texas, 76712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2011
First Posted
June 8, 2011
Study Start
August 1, 2006
Primary Completion
November 1, 2006
Study Completion
April 1, 2008
Last Updated
October 6, 2011
Record last verified: 2011-10