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This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | 200 mcg daily |
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| Placebo | Placebo Comparator | Two sprays in each nostril in the morning |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate nasal spray | Drug | Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12. | Screening through 15 days daily |
| Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9. | Screening through 15 days daily |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3. | Screening through 15 days daily |
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Inclusion Criteria:
Exclusion Criteria:
protocols.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20434199 | Result | Prenner BM, Lanier BQ, Bernstein DI, Shekar T, Teper A. Mometasone furoate nasal spray reduces the ocular symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol. 2010 Jun;125(6):1247-1253.e5. doi: 10.1016/j.jaci.2010.03.004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate Nasal Spray (MFNS) | MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg. |
| FG001 | Placebo | Two sprays in each nostril once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Two sprays in each nostril in the morning |
|
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) |
The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants. |
| Baseline and 15 days |
| Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow. | Screening through 15 days daily |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate Nasal Spray (MFNS) | MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg. |
| BG001 | Placebo | Two sprays in each nostril once daily |
| 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, Customized | One subject was 12 years of age at the time of enrollment/screening but turned 13 years of age at the time of randomization. | Number | participants |
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| Sex: Female, Male | Count of Participants | 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 Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12. | All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | Posted | Least Squares Mean | Standard Deviation | Score on a scale | Screening through 15 days daily |
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| Primary | Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9. | All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | Posted | Least Squares Mean | Standard Deviation | Score on a scale | Screening through 15 days daily |
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| Secondary | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3. | All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | Posted | Least Squares Mean | Standard Deviation | Score on a scale | Screening through 15 days daily |
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| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants. | The RQLQ tool is only validated in participants greater than or equal to 18 years of age. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age. | Posted | Least Squares Mean | Standard Deviation | Score on a scale | Baseline and 15 days |
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| Secondary | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow. | All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | Posted | Least Squares Mean | Standard Deviation | liters/minute | Screening through 15 days daily |
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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 | Mometasone Furoate Nasal Spray (MFNS) | MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg. | 0 | 220 | 0 | 220 | ||
| EG001 | Placebo | Two sprays in each nostril once daily | 0 | 209 | 0 | 209 |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's represnetatives will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| 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 |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
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| 18 - <65 years |
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| >=65 years |
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| Male |
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| Units | Counts |
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| Participants |
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