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The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Nasal Spray | Placebo Comparator | 0mg Placebo Nasal Spray |
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| 0.15% azelastine hydrochloride nasal spray | Active Comparator | 0.15% azelastine hydrochloride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo nasal spray | Drug | Placebo |
| |
| 0.15% azelastine hydrochloride Nasal Spray |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 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 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 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo | End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Least square means 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 baseline as a covariate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis M Fredane, MD | Meda Pharmaceuticals | Study Director |
| 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 |
Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
First observation: August 20, 2007 Last observation: November 14, 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Nasal Spray/2 sprays per nostril once daily for 14 days |
| FG001 | Astepro 0.15% | 0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
0.15% azelastine hydrochloride 822 mcg |
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| baseline and 14 days |
| Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 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. Least square means 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 14-days |
| Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined) | Reflective secondary symptom 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. Least square means 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 14-days |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days | A 28-item RQLQ was completed on Day 1 and Day 14 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. Total overall score is not calculated by adding all subscales scores for an overall score. 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 14 Days |
| Change From Baseline on Direct Visual Nasal Exams at 14 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 14 days |
| Long Beach |
| California |
| 90806 |
| 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 |
| Colorado Allergy and Asthma centers, PC | Lakewood | Colorado | 80401 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Aeroallergy Research Laboratories of Savannah | Savannah | Georgia | 31406 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | 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 |
| RX R+D | Metairie | Louisiana | 70001 | United States |
| Chesapeake Clinical Research, Inc | Baltimore | Maryland | 21236 | United States |
| Institute for Asthma and Allergy PC | Wheaton | Maryland | 20902 | United States |
| Clinical Research Institute | Plymouth | Minnesota | 55441 | United States |
| The Clinical Research Center | St Louis | Missouri | 63141 | United States |
| Midwest Allergy and Asthma Clinic | Omaha | Nebraska | 68130 | 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 |
| Allergy Consultants PA | Verona | New Jersey | 07044 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| OIAA Clinical Research, LLC | Edmond | Oklahoma | 73003 | United States |
| Asthma and Allergy Research Associates | Chester | Pennsylvania | 19013 | United States |
| Valley Clinical Research | Easton | Pennsylvania | 18045 | United States |
| UPMC-ENT | Pittsburgh | Pennsylvania | 15213 | United States |
| Asthma, Nasal Disease & Allergy Research Center of New England | Providence | Rhode Island | 02906 | United States |
| Pharmaceutical Research & Consulting Inc | Dallas | Texas | 75231 | United States |
| Jane Lee, MD, PA Research Center | Dallas | Texas | 75246 | United States |
| Western Sky Medical Research | El Paso | Texas | 79902 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| Advanced Healthcare, SC | Milwaukee | Wisconsin | 53209 | United States |
| Allergy and Asthma Center of Michigan | Novi | Wisconsin | 48375 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Nasal Spray/2 sprays per nostril once daily for 14 days |
| BG001 | Astepro 0.15% | 0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Age Continuous | Number of participants based on ITT population | Mean | Standard Deviation | years |
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| Sex: Female, Male | Number of participants is based on ITT population | Count of Participants | Participants |
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| Region of Enrollment | Participants are based on ITT population | Number | participants |
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| 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 14 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 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. | Posted | Least Squares Mean | Standard Deviation | scores on a scale | baseline and 14 days |
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| Secondary | Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo | End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Least square means 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 baseline as a covariate. | Posted | Sep 2009 | Least Squares Mean | Standard Deviation | scores on a scale | baseline and 14 days |
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| Secondary | Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 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. Least square means 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. | Posted | Least Squares Mean | Standard Deviation | total nasal symptom score | baseline and 14-days |
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| Secondary | Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined) | Reflective secondary symptom 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. Least square means 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. | Posted | Least Squares Mean | Standard Deviation | Refecltive secondary symptom score | baseline and 14-days |
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| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days | A 28-item RQLQ was completed on Day 1 and Day 14 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. Total overall score is not calculated by adding all subscales scores for an overall score. 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 | baseline and 14 Days |
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| Secondary | Change From Baseline on Direct Visual Nasal Exams at 14 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 | Posted | Number | Participants | baseline and 14 days |
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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 once daily for 14 days | 0 | 242 | 11 | 242 | ||
| EG001 | Astepro 0.15% | 0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days | 0 | 238 | 17 | 238 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgusia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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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 | 732-564-2351 | WWheeler@medapharma.us |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| 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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| >=65 years |
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| Male |
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