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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, parallel-group study in subjects with moderate-to-severe SAR. The study will be conducted at 8 investigational sites during the 2007-2008 Texas Mountain Cedar allergy season. After a 7-day 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), consisting of the sum of the scores of sneezing, nasal congestion, runny nose, and nasal itching. On Days -7 through 14, subjects will rate the TNSS symptoms, the 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. The 12-hour reflective TNSS, the instantaneous TNSS, the 12-hour reflective score for postnasal drip, the 12-hour reflective TOSS, and the instantaneous TOSS will be calculated based on these scores. Additional secondary efficacy variables will include reflective and individual nasal and ocular symptom scores and change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the adult 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 |
|---|---|---|---|
| MP29-02 | Experimental | azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray |
|
| azelastine Hcl 548 mcg | Active Comparator | azelastine Hcl 548 mcg nasal spray |
|
| fluticasone propionate 200 mcg | Active Comparator | fluticasone propionate 200 mcg nasal spray |
|
| placebo | Placebo Comparator | placebo nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP29-02 | Drug | azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS) | change from baseline in the 12 hour reflective total nasal symptoms 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. | day 1 to day14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | change from baseline in the 12 hour instantaneous total nasal symptoms 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. |
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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 Associates | Austin | Texas | 78731 | United States | ||
| Central Texas Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20674829 | Derived | Hampel FC, Ratner PH, Van Bavel J, Amar NJ, Daftary P, Wheeler W, Sacks H. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010 Aug;105(2):168-73. doi: 10.1016/j.anai.2010.06.008. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg | azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day |
| FG001 | Azelastine Hcl 548 Mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| azelastine Hcl | Drug | azelastine Hcl nasal spray one spray per nostril two times a day |
|
|
| fluticasone propionate | Drug | fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day |
|
|
| placebo | Drug | placebo nasal spray one spray per nostril two times a day |
|
| day 1 to day 14 |
| Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days | Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value. | day 1 to day 14 |
| New Braunfels |
| Texas |
| 78130 |
| United States |
| Southwest Allergy and Asthma Center, P.A. | San Antonio | Texas | 78229 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Allergy, Asthma Research Center | San Antonio | Texas | 78258 | United States |
| Allergy and Asthma Care | Waco | Texas | 76708 | United States |
| Allergy and Asthma Center | Waco | Texas | 76712 | United States |
azelastine Hcl nasal spray one spray per nostril two times a day
| FG002 | Fluticasone Propionate 200 Mcg | fluticasone propionate nasal spray one spray per nostril two times a day |
| FG003 | Placebo | nasal spray |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg | azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day |
| BG001 | Azelastine Hcl 548 Mcg | azelastine Hcl nasal spray one spray per nostril two times a day |
| BG002 | Fluticasone Propionate 200 Mcg | fluticasone propionate nasal spray one spray per nostril two times a day |
| BG003 | 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 the 12 hour reflective total nasal symptoms 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. | Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation | Posted | Least Squares Mean | Standard Deviation | units on a scale | day 1 to day14 |
|
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| Secondary | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | change from baseline in the 12 hour instantaneous total nasal symptoms 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. | Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy evaluation | Posted | Least Squares Mean | Standard Deviation | units on a scale | day 1 to day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days | Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value. | Intent to Treat(ITT) population (18 years of age or older) who have had at least one post baseline efficacy evaluation | 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 | Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg | azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day | 0 | 153 | 28 | 153 | ||
| EG001 | Azelastine Hcl 548 Mcg | azelastine Hcl nasal spray one spray per nostril two times a day | 0 | 152 | 15 | 152 | ||
| EG002 | Fluticasone Propionate 200 Mcg | fluticasone propionate nasal spray one spray per nostril two times a day | 0 | 151 | 13 | 151 | ||
| EG003 | Placebo | nasal spray | 0 | 151 | 10 | 151 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysgusia | Gastrointestinal disorders | medra 10.0 | Systematic Assessment |
| |
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| pharyngolaryngeal pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| acute sinusitis | Infections and infestations | MedDRA (10.0) | 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, D.O. | Meda Pharmaceuticals | 7325642364 | 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 |
|---|---|
| C573864 | MP29-02 |
| C020976 | azelastine |
| D000068298 | Fluticasone |
| 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 |
|
placebo nasal spray one spray per nostril two times a day |
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nasal spray
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