Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 0.15% azelastine hydrochloride 1644 mcg |
|
| 2 | Experimental | Mometasone furoate 200 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.15% azelastine hydrochloride | Drug | 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline to 12 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lewis M. Fredane, MD | Meda Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Research Excellence, LLC | Oxford | Alabama | 36203 | United States | ||
| AABI Associates Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39885937 | Derived | Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Kumar Ramalingam R, Canonica GW, Berger WE. In perennial allergic rhinitis, RQLQ is improved similarly by Azelastine 0.15 and mometasone furoate. World Allergy Organ J. 2025 Jan 8;18(1):101021. doi: 10.1016/j.waojou.2024.101021. eCollection 2025 Jan. |
Not provided
Not provided
Subjects participated in a 7 day screening period to identify appropriate subjects based on symptom scores.
First observation: 09 MAR 2007 Last observation: 20 JUN 2008
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Astepro 0.15% | 0.15% azelastine hydrochloride 1644 mcg |
| FG001 | Nasonex® | Mometasone furoate 200 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mometasone furoate | Drug | 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM) |
|
| change from baseline to 12 months |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Allergy and Asthma Specialist Medical Group | Huntington Beach | California | 92647 | 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 Associates Medical Group Inc | San Diego | California | 92120 | United States |
| Allergy and Asthma Medical Group and Research Center | San Diego | California | 92123 | United States |
| Allergy & Asthma Associates of Santa Clara Valley Research Cntr | San Jose | California | 95117 | 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 |
| Allergy and Asthma Care of Florida | Ocala | Florida | 34471 | United States |
| Allergy and Asthma DTC | Tallahassee | Florida | 32308 | United States |
| Georgia Pollens Clinical Research Centers Inc | Albany | Georgia | 31707 | 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 |
| RX R+D | Metairie | Louisiana | 70001 | United States |
| Institute for Asthma and Allergy PC | Wheaton | Maryland | 20902 | 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 |
| The Asthma and Allergy Center | Papillion | Nebraska | 68046 | United States |
| Las Vegas Physicians Research Group | Henderson | Nevada | 89052 | United States |
| Allergy and Asthma Research NJ inc | Mount Laurel | New Jersey | 08054 | United States |
| Atlantic Research Center | Ocean City | New Jersey | 07712 | United States |
| Dr. Perin | Teaneck | New Jersey | 07666 | United States |
| Medical Research Associates of CNY, PLLC | North Syracuse | New York | 13212 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| New Horizon's Clinical Research | Cincinnati | Ohio | 45252 | United States |
| Oklahoma Institute of Allergy and Asthma Clinical | Edmond | Oklahoma | 73003 | United States |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Allergy Asthma and Dermatology Research | Lake Oswego | Oregon | 97035 | United States |
| Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | 97504 | United States |
| Allergy and Asthma Specialist PC | Blue Bell | Pennsylvania | 19422 | 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 |
| Asthma, Nasal Disease & Allergy Research Center of New England | Providence | Rhode Island | 02906 | United States |
| National Allergy, Asthma and Urticaria of Charleston | Charleston | South Carolina | 29407 | United States |
| Allergy and Asthma Associates | Austin | Texas | 78731 | 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 |
| SWAAA Research Center | Houston | Texas | 77074 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Biogenics Research Institute | San Antonio | Texas | 78229 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Live Oak Allergy and Asthma Clinic | San Antonio | Texas | 78233 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| VA Adult and Pediatric Allergy and Asthma | Richmond | Virginia | 23229 | United States |
| Asthma, Inc. | Seattle | Washington | 98105 | United States |
| Advanced Healthcare | Milwaukee | Wisconsin | 53209 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Astepro 0.15% | 0.15% azelastine hydrochloride 1644 mcg |
| BG001 | Nasonex® | Mometasone furoate 200 mcg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | Participants | Change from baseline to 12 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | 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. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | change from baseline to 12 months |
|
|
12 Months
Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Astepro 0.15% | 0.15% azelastine hydrochloride 1644 mcg | 4 | 466 | 349 | 466 | ||
| EG001 | Nasonex® | Mometasone furoate 200 mcg | 4 | 237 | 163 | 237 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| CYSTOCELE | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSGEUSIA | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| SINUS HEADACHE | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| MUCOSAL EROSION | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
For multicenter studies, joint publication is required to assure that the initial publication is based on all data from all sites and investigators participating in these studies agree not to present data gathered individually or by subgroup centers before the initial publication unless jointly agreed by all other investigators and the sponsor. Authorship will be determined by mutual agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Wheeler, PhD | Meda Pharmaceuticals | 732-564-2393 | WWheeler@medapharma.us |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C020976 | azelastine |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Epistaxis - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Nasal Irritation - Day 1 |
|
| None |
|
| Grade 1A |
|
| Grade 1B |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Nasal Irritation - Month 12/ET |
|
| None |
|
| Grade 1A |
|
| Grade 1B |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Conjunctival injection - Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Conjunctival injection - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Erythematous TM - Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Erythematous TM - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Lymphadenophthy-Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Lymphadenopathy - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mucosal Edema - Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mucosal Edema - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Nasal Discharge - Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Nasal Discharge - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mucosal Erythema - Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mucosal Erythema - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mucosal Bleeding - Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mucosal Bleeding - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Crusting of Mucosa - Day 1 |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Crusting of Mucosa - Month 12/ET |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
|
|