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The purpose of this study was to determine if two allergy medications are more effective than placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Nasal Spray | Placebo Comparator | Placebo nasal spray |
|
| Astepro 0.1% | Experimental | 0.1% azelastine hydrochloride nasal spray |
|
| Astepro 0.15% | Experimental | 0.15% azelastine hydrochloride nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.15% azelastine hydrochloride 1644 mcg daily | Drug | 0.15% azelastine hydrochloride 1644 mcg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo | rTNSS 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. (maximum 12 points per assessment.) 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 baseline as a covariate. | baseline and 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Research Excellence, LLC | Oxford | Alabama | 36203 | United States | ||
| Clinical Research Center |
Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
First observation: 14 Aug 2007 Last observation: 19 Nov 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days |
| FG001 | Astepro 0.1% | 0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 0.1% azelastine hydrochloride 1096 mcg daily | Drug | 0.1% azelastine hydrochloride 1096 mcg daily |
|
|
| Placebo | Drug | 0 mcg Placebo daily |
|
| baseline and 14 Days |
| Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) 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 to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | 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. 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 | 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 | 14 days |
| Encinitas |
| California |
| 92024 |
| 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 |
| Storms Clinical Research Institute | Colorado Springs | Colorado | 80907 | United States |
| Colorado Allergy and Asthma Centers | Denver | Colorado | 80230 | United States |
| ENTA Allergy, Head and Neck Associates | Decatur | Illinois | 62526 | United States |
| Sneeze, Wheeze and Itch Associates | Normal | Illinois | 61761 | United States |
| Family Allergy and Asthma Reserach | Louisville | Kentucky | 40215 | United States |
| Northeast Medical Research Associates | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Research Institute | Plymouth | Minnesota | 55441 | United States |
| Allergy, Asthma and Immunology Associates | Lincoln | Nebraska | 68505 | United States |
| Atlantic Research Center | Ocean City | New Jersey | 07712 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| Research Asthma, Sinus and Allergy Centers | Warren Township | New Jersey | 07059 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Allergy and Consultants of NJ/PA | Collegeville | Pennsylvania | 19426 | United States |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| National Allergy, Asthma and Urticaria of Charleston | Charleston | South Carolina | 29407 | United States |
| East Tennesse Center for Clinical Research | Knoxville | Tennessee | 37909 | United States |
| Allergy and Asthma Associates | Austin | Texas | 78731 | 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 |
| Allergy and Asthma Care | Waco | Texas | 76708 | United States |
| FG002 | Astepro 0.15% | 0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days |
| BG001 | Astepro 0.1% | 0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days |
| BG002 | Astepro 0.15% | 0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days |
| 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(rTNSS)for the Entire 14-day Study Period Compared to Placebo | rTNSS 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. (maximum 12 points per assessment.) 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 baseline as a covariate. | Posted | Least Squares Mean | Standard Deviation | total nasal symptom score | baseline and 14 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo | Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) 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 | Reflective secondary symptom score | baseline and 14 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older | 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. 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 | 28 item/7 domain RQLQ on 0-6 scale | baseline and 14 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on Direct Visual Nasal Exams | 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 | 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 taken 2 sprays per nostril twice a day for 14 days | 2 | 178 | 5 | 178 | ||
| EG001 | Astepro 0.1% | 0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days | 0 | 170 | 21 | 170 | ||
| EG002 | Astepro 0.15% | 0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days | 0 | 178 | 19 | 178 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exposure in utero | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgesusia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nasal Discomfort | 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 |
|---|---|
| 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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| ID | Term |
|---|---|
| C020976 | azelastine |
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| Between 18 and 65 years |
|
| >=65 years |
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| Male |
|
|
Change in baseline to Day 14 |
| ANCOVA |
ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score. |
| <0.001 |
| Mean Difference (Final Values) |
| -3.00 |
| Standard Deviation |
| 0.465 |
| 95 |
| -3.91 |
| -2.09 |
| No |
| Superiority or Other |
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| Participants |
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