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The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluticasone propionate | Active Comparator |
| |
| azelastineHcl/fluticasone propionate | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| azelastine Hcl | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo |
| |
| azelastine Hcl |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) | change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result. | days 1 to 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result. |
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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, Asthma and Immunology Associates | Scottsdale | Arizona | 85251 | United States | ||
| Clinical Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP29-02 | MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray |
| FG001 | Fluticasone Propionate | fluticasone propionate nasal spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
azelastine Hcl 548 mcg |
|
|
| azelastineHcl / fluticasone propionate | Drug | azelastine Hcl 548 mcg / fluticasone propionate 200 mcg |
|
|
| fluticasone propionate | Drug | fluticasone propionate 200 mcg |
|
|
| day 1 to day 14 |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days | adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14. The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result. | day 1 to day 14 |
| Encinitas |
| California |
| 92024 |
| United States |
| Allergy Research Foundation | Los Angeles | California | 90025 | United States |
| Southern California Research | Mission Viejo | California | 92691 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Allergy and Asthma Medical Group and Research Center | San Diego | California | 92123 | United States |
| Bensch Research Associates | Stockton | California | 95207 | United States |
| Allergy and Asthma Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Storms Clinical Research Institute | Colorado Springs | Colorado | 80907 | United States |
| Colorado Allergy and Asthma Centers | Denver | Colorado | 80230 | United States |
| Colorado Allergy and Asthma Centers | Lakewood | Colorado | 80401 | United States |
| Clinical Research Atlanta | Atlanta | Georgia | 30342 | 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 |
| 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 |
| Allergy, Asthma and Immunology Associates | Lincoln | Nebraska | 68505 | United States |
| The Asthma and Allergy Center | Papillion | Nebraska | 68046 | United States |
| Atlantic Research Center | Ocean City | New Jersey | 07712 | United States |
| Research Asthma, Sinus and Allergy Centers | Warren Township | New Jersey | 07059 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| Island Medical Research | Rockville Centre | New York | 11570 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Allergy Clinic of Tulsa | Tulsa | Oklahoma | 74133 | United States |
| Allergy Asthma and Dermatology Research | Lake Oswego | Oregon | 97035 | 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 |
| 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 |
| Allergy and Asthma Center of Austin | Austin | Texas | 78759 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Jane Lee, MD, PA Research Center | Dallas | Texas | 75246 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Intermountain Clinical Research | Draper | Utah | 84020 | United States |
| Asthma, Inc. | Seattle | Washington | 98105 | United States |
| FG002 | Azelastine HCl | azelastine HCl nasal spray nasal spray |
| FG003 | Placebo | placebo nasal spray |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP29-02 | MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray |
| BG001 | Fluticasone Propionate | fluticasone propionate nasal spray |
| BG002 | Azelastine HCl | azelastine HCl nasal spray nasal spray |
| BG003 | Placebo | placebo nasal spray |
| BG004 | 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 in 12-hour Reflective Total Nasal Symptom Score (rTNSS) | change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result. | intent to treat population (ITT)- must have had at least one post baseline efficacy assessment | Posted | Least Squares Mean | Standard Deviation | units on a scale | days 1 to 14 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result. | intent to treat population (ITT)- must have had at least one post baseline efficacy assessment | Posted | Least Squares Mean | Standard Deviation | units on a scale | day 1 to day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days | adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14. The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result. | intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment | Posted | Least Squares Mean | Standard Deviation | units on a scale | day 1 to day 14 |
|
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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 | MP29-02 | MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray | 0 | 207 | 12 | 207 | ||
| EG001 | Fluticasone Propionate | fluticasone propionate nasal spray | 0 | 207 | 16 | 207 | ||
| EG002 | Azelastine HCl | azelastine HCl nasal spray nasal spray | 0 | 208 | 19 | 208 | ||
| EG003 | Placebo | placebo nasal spray | 0 | 210 | 7 | 210 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysgusia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Investigators participating in multicenter studies must agree not to present data gathered individually or by a subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and Meda Pharmaceuticals.
Meda Pharmaceuticals requests that it receive copies of any intended communication reasonably in advance (at least 15 working days for an abstract or oral presentation and 45 working days for a manuscript)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Ginsberg,.. | Meda Pharmaceutical | 732 564 2364 | david.ginsberg@meda.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 |
| D000068298 | Fluticasone |
| C573864 | MP29-02 |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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