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The purpose of this study is to determine if two allergy medications are more effective than placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks |
|
| 3 | Experimental | 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.15% azelastine hydrochloride | Drug | 0.15% azelastine hydrochloride 1644 mcg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. | baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy and Asthma Specialist Medical Group | Huntington Beach | California | 92647 | United States | ||
| Allergy, Asthma and Respiratory Care medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37920410 | Derived | Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Ramalingam RK, Canonica GW, Berger WE. A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis. Front Allergy. 2023 Oct 18;4:1244012. doi: 10.3389/falgy.2023.1244012. eCollection 2023. |
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Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
First Observation: February 5, 2007 Last Observation: October 8, 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks |
| FG001 | Astepro 0.1% | 0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 0.1% azelastine hydrochloride |
| Drug |
0.1% azelastine hydrochloride 1096 mcg |
|
| Placebo | Drug | Placebo |
|
| baseline and 28 days |
| Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day. | baseline and 28 days |
| Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. 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. | baseline and 28 Days |
| Change From Baseline on Direct Visual Nasal Exams and 28 Days | 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 irratation 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 | baseline and 28 days |
| 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 and Asthma Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Asthma and Allergy Associates | Colorado Springs | Colorado | 80907 | United States |
| The William Storms Allergy Clinic | Colorodo Springs | Colorado | 80907 | United States |
| Atlanta Allergy and Asthma Clinic | Woodstock | Georgia | 30188 | United States |
| Sneeze, Wheeze and Itch Associates | Normal | Illinois | 61761 | United States |
| Kansas City Allergy and Asthma | Overland Park | Kansas | 66210 | 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 |
| 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 |
| 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 |
| 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 Consultants of NJ/PA | Collegeville | Pennsylvania | 19426 | 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 |
| Central Texas 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 |
| Allergy and Asthma Center | Waco | Texas | 76712 | United States |
| Virginia Adult & Pediactric Allergy & Asthma, PC | Richmond | Virginia | 23229 | United States |
| Asthma, Inc. | Seattle | Washington | 98105 | United States |
| Advanced Healthcare, SC | Milwaukee | Wisconsin | 53209 | United States |
| FG002 | Astepro 0.15% | 0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks |
| BG001 | Astepro 0.1% | 0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks |
| BG002 | Astepro 0.15% | 0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks |
| BG003 | 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 | Number of participants based on ITT population | Count of Participants | Participants |
| |||||||||||||||
| Age Continuous | Number of participants based on ITT population | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Number of participants based on ITT population | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number of participants based on ITT population | 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 in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. | ITT | Posted | Number | Scores on a Scale | baseline and 28 days |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. | ITT | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | baseline and 28 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day. | ITT | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | baseline and 28 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. 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. | ITT | Posted | Least Squares Mean | Standard Deviation | Units on a Scale | baseline and 28 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on Direct Visual Nasal Exams and 28 Days | 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 irratation 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 | ITT | Posted | Number | Participants | baseline and 28 days |
|
|
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0 participants were at risk for an SAE. No SAE's were observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks | 0 | 192 | 21 | 192 | ||
| EG001 | Astepro 0.1% | 0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks | 0 | 194 | 27 | 194 | ||
| EG002 | Astepro 0.15% | 0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks | 0 | 192 | 32 | 192 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dysgesusia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Standard deviations for primary endpoint are not available.
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 |
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| ID | Term |
|---|---|
| C020976 | azelastine |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score. |
| 0.08 |
| Mean Difference (Final Values) |
| -0.7 |
| 95 |
| -1.5 |
| 0.1 |
| No |
| Superiority or Other |
| Participants |
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| Participants |
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