Back to resultsA Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0.15% azelastine hydrochloride
Mometasone furoate
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
- Must be willing and able to provide informed consent and to participate in all study procedures
- Must be in generally good health
- Positive skin test to a prevalent perennial allergen
Exclusion Criteria:
- On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Use of any investigational drug within 30 days of the first visit
- Any nasal surgery or sinus surgery within the previous year
- Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
- Women who are pregnant or nursing
- Women who are not using an acceptable method of birth control
- Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
- Patients with Arrythmia
- Patients with know history of alcohol and drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
- Use of medications that could affect the study results
Sites / Locations
- Center of Research Excellence, LLC
- AABI Associates Medical Group
- Allergy and Asthma Specialist Medical Group
- West Coast Clinical Trials
- Allergy Research Foundation
- Southern California Research
- Allergy Associates Medical Group Inc
- Allergy and Asthma Medical Group and Research Center
- Allergy & Asthma Associates of Santa Clara Valley Research Cntr
- Bensch Research Associates
- Allergy and Asthma Clinical Research, Inc.
- Asthma and Allergy Associates
- Allergy and Asthma Care of Florida
- Allergy and Asthma DTC
- Georgia Pollens Clinical Research Centers Inc
- Aeroallergy Research Laboratories of Savannah
- Clinical Research Atlanta
- Sneeze, Wheeze and Itch Associates
- Kansas City Allergy and Asthma
- RX R+D
- Institute for Asthma and Allergy PC
- Northeast Medical Research Associates
- Clinical Research Institute
- Clinical Research Institute
- The Clinical Research Center
- The Asthma and Allergy Center
- Las Vegas Physicians Research Group
- Allergy and Asthma Research NJ inc
- Atlantic Research Center
- Dr. Perin
- Medical Research Associates of CNY, PLLC
- AAIR Research Center
- North Carolina Clinical Research
- Wake Research Associates, LLC
- Bernstein Clinical Research Center
- New Horizon's Clinical Research
- Oklahoma Institute of Allergy and Asthma Clinical
- Allergy, Asthma and Clinical Research Center
- Allergy Asthma and Dermatology Research
- Clinical Research Institute of Southern Oregon, PC
- Allergy and Asthma Specialist PC
- Allergy and Consultants of NJ/PA
- Allergy and Clinical Immunology Associates
- Asthma and Allergy Research Associate
- Asthma, Nasal Disease & Allergy Research Center of New England
- National Allergy, Asthma and Urticaria of Charleston
- Allergy and Asthma Associates
- AARA Research Center
- Pharmaceutical Research & Consulting Inc
- Western Sky Medical Research
- SWAAA Research Center
- Central Texas Health Research
- Biogenics Research Institute
- Sylvana Research Associates
- Live Oak Allergy and Asthma Clinic
- Allergy Asthma Research Institute
- VA Adult and Pediatric Allergy and Asthma
- Asthma, Inc.
- Advanced Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
0.15% azelastine hydrochloride 1644 mcg
Mometasone furoate 200 mcg
Outcomes
Primary Outcome Measures
Change From Baseline on Direct Visual Nasal Exams to 12 Months
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00720382
Brief Title
A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
Official Title
Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meda Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
703 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
0.15% azelastine hydrochloride 1644 mcg
Arm Title
2
Arm Type
Experimental
Arm Description
Mometasone furoate 200 mcg
Intervention Type
Drug
Intervention Name(s)
0.15% azelastine hydrochloride
Intervention Description
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate
Intervention Description
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
Primary Outcome Measure Information:
Title
Change From Baseline on Direct Visual Nasal Exams to 12 Months
Description
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Time Frame
Change from baseline to 12 months
Other Pre-specified Outcome Measures:
Title
Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
Description
A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Time Frame
change from baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
Must be willing and able to provide informed consent and to participate in all study procedures
Must be in generally good health
Positive skin test to a prevalent perennial allergen
Exclusion Criteria:
On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
Use of any investigational drug within 30 days of the first visit
Any nasal surgery or sinus surgery within the previous year
Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
Women who are pregnant or nursing
Women who are not using an acceptable method of birth control
Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
Patients with Arrythmia
Patients with know history of alcohol and drug abuse
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
Use of medications that could affect the study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis M. Fredane, MD
Organizational Affiliation
Meda Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Center of Research Excellence, LLC
City
Oxford
State/Province
Alabama
ZIP/Postal Code
36203
Country
United States
Facility Name
AABI Associates Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Allergy and Asthma Specialist Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
West Coast Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Allergy Research Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Allergy Associates Medical Group Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Allergy and Asthma Medical Group and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Bensch Research Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Allergy and Asthma Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Asthma and Allergy Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Allergy and Asthma Care of Florida
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Allergy and Asthma DTC
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers Inc
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Aeroallergy Research Laboratories of Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Sneeze, Wheeze and Itch Associates
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Kansas City Allergy and Asthma
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
RX R+D
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Institute for Asthma and Allergy PC
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Northeast Medical Research Associates
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
The Clinical Research Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
The Asthma and Allergy Center
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Las Vegas Physicians Research Group
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Allergy and Asthma Research NJ inc
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Atlantic Research Center
City
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Dr. Perin
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Medical Research Associates of CNY, PLLC
City
North Syracuse
State/Province
New York
ZIP/Postal Code
13212
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Bernstein Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
New Horizon's Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45252
Country
United States
Facility Name
Oklahoma Institute of Allergy and Asthma Clinical
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73003
Country
United States
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Allergy Asthma and Dermatology Research
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy and Asthma Specialist PC
City
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
Allergy and Consultants of NJ/PA
City
Collegeville
State/Province
Pennsylvania
ZIP/Postal Code
19426
Country
United States
Facility Name
Allergy and Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Asthma and Allergy Research Associate
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Asthma, Nasal Disease & Allergy Research Center of New England
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
National Allergy, Asthma and Urticaria of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Allergy and Asthma Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pharmaceutical Research & Consulting Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
SWAAA Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Biogenics Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Live Oak Allergy and Asthma Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
VA Adult and Pediatric Allergy and Asthma
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Asthma, Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Advanced Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
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