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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0887-064 | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Integrated Therapeutics Group | INDUSTRY |
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This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone | Experimental | Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks |
|
| Placebo | Placebo Comparator | Matching placebo nasal spray, administered QD for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone | Drug | Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Each morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her asthma symptoms. The TASS was the sum of severity scores for 4 asthma symptoms: cough, wheeze, difficulty of breathing, and chest tightness. The severity of each asthma symptom was rated on a 4-point scale (0=no symptom; 3=severe); minimum TASS=0; maximum TASS=12. A decrease in TASS indicated an improvement in asthma symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AM and PM Cough Symptom Score | Cough is an asthma symptom assessed by participants who used diary cards to record morning and evening cough (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her coughing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Cough was rated on a 4-point scale (0=no symptoms [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). Reduction in score indicated an improvement in cough symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medial Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone | Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks |
| FG001 | Placebo | Matching placebo nasal spray, administered QD for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One participant in the mometasone treatment group did not have any post-baseline assessment and was excluded from the Intent-to-Treat (ITT) population, for which baseline demograpic characteristics were summarized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone | Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks |
| BG001 | Placebo | Matching placebo nasal spray, administered QD for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Each morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her asthma symptoms. The TASS was the sum of severity scores for 4 asthma symptoms: cough, wheeze, difficulty of breathing, and chest tightness. The severity of each asthma symptom was rated on a 4-point scale (0=no symptom; 3=severe); minimum TASS=0; maximum TASS=12. A decrease in TASS indicated an improvement in asthma symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
|
Up to 59 days
An AE is any physical or clinical change or disease the participant experiences at any time during the course of the study, whether or not considered related to the use of the study drug. The population analyzed is all randomized participants who receive at least one dose of treatment.
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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 | Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture, bone | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | MedDRA 9.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | Matching placebo nasal spray, administered QD as 2 sprays in each nostril. |
|
| Albuterol/Salbutamol | Drug | Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication. |
|
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| Baseline up to Week 4 |
| Change From Baseline in AM and PM Wheeze Symptom Score | Wheezing is a symptom of asthma. The wheezing assessment was based on participant diary data only. Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her wheezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Wheeze severity was rated on a 4-point scale (0=no wheezing [best score] to 3=wheezing was hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Difficulty breathing is an asthma symptom assessed by participants using diary cards to record morning and evening difficulty breathing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her difficulty breathing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Difficulty breathing was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in AM and PM Chest Tightness Symptom Score | Chest tightness is an asthma symptom assessed by participants using diary cards to record morning and evening chest tightness (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her chest tightness for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). The severity of chest tightness was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Wheezing was assessed by the investigator or designee based upon pulmonary auscultation (listening with a stethoscope) and reported in the case report form as present or absent. The count of wheezing presence (yes, no) at visits was summarized. | Baseline, Day 15 and Day 29 |
| Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | The Total Nasal Symptom Severity (TNSS) is the sum of severity scores for 4 nasal symptoms: nasal rhinorrhea, nasal stuffiness/congestion, sneezing, and nasal itching as assessed in the participant diaries. The severity of each nasal symptom was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]); minimum TNSS=0; maximum TNSS=12. A decrease in TNSS indicated an improvement in nasal symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in AM and PM Rhinorrhea Symptom Score | Rhinorrhea is a symptom of seasonal allergic rhinitis (SAR) assessed by participants using diary cards to record morning and evening rhinorrhea (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her rhinorrhea for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Rhinorrhea was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in AM and PM Nasal Itching Symptom Score | Nasal itching is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal itching (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal itching for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Nasal sneezing is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal sneezing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal sneezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms a were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in AM and PM Nasal Congestion Symptom Score | Nasal congestion is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal congestion (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal congestion for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Participants used a peak flow meter to measure the rate of air forcibly expelled from the lungs. They performed triplicate PEFR measurements in the morning prior to taking their study medication and again in the evening, and documented the highest of the three values in their diaries. A day with worsening asthma was any day during which a decrease from baseline in morning (AM) PEFR of more than 25% occurred. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Measured by the investigator (or a designated assistant) using a spirometer, FEV1 is the volume of air forcibly expelled from the lungs in one second. | Baseline, Day 15 and Day 29 |
| Change From Baseline in Forced Vital Capacity (FVC) | Measured by the investigator (or a designated assistant) using a spirometer, FVC is the total volume of air forcibly expelled from the lungs after taking the deepest breath possible. | Baseline, Day 15 and Day 29 |
| Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Measured by the investigator (or a designated assistant) using a spirometer, FEF25%-75% is the average forcibly expelled air flow rate, measured between 75% and 25% of FVC. | Baseline, Day 15 and Day 29 |
| Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Once daily, participants recorded in their diaries the total number of puffs of albuterol/salbutamol used in each 24-hour period. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Participants recorded the number of times during the night they awakened due to asthma. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in Weekly Average Interference With Sleep | Interference with sleep was rated once each morning using a 4-point scale ranging from 0 (none) to 3 (substantially interferes with sleep). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Change From Baseline in Weekly Average Interference With Daily Activities | Interference with daily activities was rated once each evening using a 4-point scale ranging from 0 (none) to 3 (substantially interfered with activities or not able to perform the activities at all). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | Baseline up to Week 4 |
| Therapeutic Response to Asthma Symptoms | On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of asthma symptoms with those noted on Day 1. Therapeutic response for asthma symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). | Day 15 and Day 29 |
| Therapeutic Response to SAR Nasal Symptoms | On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of SAR symptoms with those noted on Day 1. Therapeutic response for SAR symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). | Day 15 and Day 29 |
| Protocol Violation |
|
| Unrelated to Study Medication |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks |
| OG001 | Placebo | Matching placebo nasal spray, administered QD for 4 weeks |
|
|
|
| Secondary | Change From Baseline in AM and PM Cough Symptom Score | Cough is an asthma symptom assessed by participants who used diary cards to record morning and evening cough (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her coughing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Cough was rated on a 4-point scale (0=no symptoms [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). Reduction in score indicated an improvement in cough symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Wheeze Symptom Score | Wheezing is a symptom of asthma. The wheezing assessment was based on participant diary data only. Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her wheezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Wheeze severity was rated on a 4-point scale (0=no wheezing [best score] to 3=wheezing was hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Difficulty breathing is an asthma symptom assessed by participants using diary cards to record morning and evening difficulty breathing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her difficulty breathing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Difficulty breathing was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Chest Tightness Symptom Score | Chest tightness is an asthma symptom assessed by participants using diary cards to record morning and evening chest tightness (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her chest tightness for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). The severity of chest tightness was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Wheezing was assessed by the investigator or designee based upon pulmonary auscultation (listening with a stethoscope) and reported in the case report form as present or absent. The count of wheezing presence (yes, no) at visits was summarized. | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Count of Participants | Participants | Baseline, Day 15 and Day 29 |
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| Secondary | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | The Total Nasal Symptom Severity (TNSS) is the sum of severity scores for 4 nasal symptoms: nasal rhinorrhea, nasal stuffiness/congestion, sneezing, and nasal itching as assessed in the participant diaries. The severity of each nasal symptom was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]); minimum TNSS=0; maximum TNSS=12. A decrease in TNSS indicated an improvement in nasal symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Rhinorrhea is a symptom of seasonal allergic rhinitis (SAR) assessed by participants using diary cards to record morning and evening rhinorrhea (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her rhinorrhea for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Rhinorrhea was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Nasal Itching Symptom Score | Nasal itching is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal itching (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal itching for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Nasal sneezing is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal sneezing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal sneezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms a were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Nasal congestion is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal congestion (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal congestion for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
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| Secondary | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Participants used a peak flow meter to measure the rate of air forcibly expelled from the lungs. They performed triplicate PEFR measurements in the morning prior to taking their study medication and again in the evening, and documented the highest of the three values in their diaries. A day with worsening asthma was any day during which a decrease from baseline in morning (AM) PEFR of more than 25% occurred. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Liters/min | Baseline up to Week 4 |
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| Secondary | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Measured by the investigator (or a designated assistant) using a spirometer, FEV1 is the volume of air forcibly expelled from the lungs in one second. | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, Day 15 and Day 29 |
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| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | Measured by the investigator (or a designated assistant) using a spirometer, FVC is the total volume of air forcibly expelled from the lungs after taking the deepest breath possible. | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, Day 15 and Day 29 |
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| Secondary | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Measured by the investigator (or a designated assistant) using a spirometer, FEF25%-75% is the average forcibly expelled air flow rate, measured between 75% and 25% of FVC. | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Liters/sec | Baseline, Day 15 and Day 29 |
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| Secondary | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Once daily, participants recorded in their diaries the total number of puffs of albuterol/salbutamol used in each 24-hour period. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Number of puffs | Baseline up to Week 4 |
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|
| Secondary | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Participants recorded the number of times during the night they awakened due to asthma. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Awakenings | Baseline up to Week 4 |
|
|
|
|
| Secondary | Change From Baseline in Weekly Average Interference With Sleep | Interference with sleep was rated once each morning using a 4-point scale ranging from 0 (none) to 3 (substantially interferes with sleep). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
|
|
|
|
| Secondary | Change From Baseline in Weekly Average Interference With Daily Activities | Interference with daily activities was rated once each evening using a 4-point scale ranging from 0 (none) to 3 (substantially interfered with activities or not able to perform the activities at all). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline up to Week 4 |
|
|
|
|
| Secondary | Therapeutic Response to Asthma Symptoms | On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of asthma symptoms with those noted on Day 1. Therapeutic response for asthma symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Mean | Standard Deviation | Score on a scale | Day 15 and Day 29 |
|
|
|
|
| Secondary | Therapeutic Response to SAR Nasal Symptoms | On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of SAR symptoms with those noted on Day 1. Therapeutic response for SAR symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). | All randomized participants who had at least one post-baseline assessment at the specified timepoint. | Posted | Mean | Standard Deviation | Score on a scale | Day 15 and Day 29 |
|
|
|
|
| 0 |
| 113 |
| 1 |
| 113 |
| 4 |
| 113 |
| EG001 | Placebo | Matching placebo nasal spray, administered QD for 4 weeks | 0 | 75 | 1 | 75 | 4 | 75 |
| Periodontitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
Manuscript(s) and abstract(s) were prepared through cooperation between the sponsor and the study investigator(s). The principal investigator (PI) had the right to publish or publicly present the Study results. The PI agreed to provide thirty (30) days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication. The sponsor had the right to review and comment on any publication.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.693 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.483 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.088 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.210 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.178 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.055 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.915 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.471 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.110 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.305 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.461 | Superiority or Other (legacy) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.116 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.749 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.289 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.982 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.941 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.128 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.484 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.673 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.250 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.450 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.774 | Superiority or Other (legacy) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.492 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.945 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.359 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.802 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.716 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.158 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.281 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.901 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.433 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.730 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.819 | Superiority or Other (legacy) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.038 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.182 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.149 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.035 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.056 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.711 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.098 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.356 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.529 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.617 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.422 | Superiority or Other (legacy) |
| Absent at Baseline |
|
|
| Present on Day 15 |
|
|
| Absent on Day 15 |
|
|
| Present on Day 29 |
|
|
| Absent on Day 29 |
|
|
| Superiority or Other (legacy) |
Day 15 |
| Cochran-Mantel-Haenszel | 0.227 | Superiority or Other (legacy) | Day 29 |
| Week 1 (AM) |
|
|
| Week 2 (AM) |
|
|
| Week 3 (AM) |
|
|
| Week 4 (AM) |
|
|
| Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Week 1 (PM) |
|
|
| Week 2 (PM) |
|
|
| Week 3 (PM) |
|
|
| Week 4 (PM) |
|
|
| Final Week (PM) |
|
|
| 0.022 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.012 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.001 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.033 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.047 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.269 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.308 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.050 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.014 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.100 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.139 | Superiority or Other (legacy) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.126 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.107 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.006 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.030 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.037 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.146 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.426 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.259 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.026 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.022 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.043 | Superiority or Other (legacy) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.014 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.004 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.002 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.027 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.069 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.373 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.148 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.009 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.016 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.113 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.173 | Superiority or Other (legacy) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.014 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.004 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.001 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.041 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.036 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.170 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.237 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.019 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.018 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.149 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.231 | Superiority or Other (legacy) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.250 |
| Superiority or Other (legacy) |
| ANOVA | 0.202 | Superiority or Other (legacy) | Change at Week 2 (AM) |
| ANOVA | 0.104 | Superiority or Other (legacy) | Change at Week 3 (AM) |
| ANOVA | 0.348 | Superiority or Other (legacy) | Change at Week 4 (AM) |
| ANOVA | 0.355 | Superiority or Other (legacy) | Change at Final Week (AM) |
| ANOVA | 0.851 | Superiority or Other (legacy) | Baseline (PM) |
| ANOVA | 0.993 | Superiority or Other (legacy) | Change at Week 1 (PM) |
| ANOVA | 0.476 | Superiority or Other (legacy) | Change at Week 2 (PM) |
| ANOVA | 0.149 | Superiority or Other (legacy) | Change at Week 3 (PM) |
| ANOVA | 0.616 | Superiority or Other (legacy) | Change at Week 4 (PM) |
| ANOVA | 0.527 | Superiority or Other (legacy) | Change at Final Week (PM) |
| Change at Week 1 (AM) |
|
|
| Change at Week 2 (AM) |
|
|
| Change at Week 3 (AM) |
|
|
| Change at Week 4 (AM) |
|
|
| Change at Final Week (AM) |
|
|
| Baseline (PM) |
|
|
| Change at Week 1 (PM) |
|
|
| Change at Week 2 (PM) |
|
|
| Change at Week 3 (PM) |
|
|
| Change at Week 4 (PM) |
|
|
| Change at Final Week (PM) |
|
|
| 0.994 |
| Superiority or Other (legacy) |
| Change at Week 2 (AM) | ANOVA | 0.961 | Superiority or Other (legacy) |
| Change at Week 3 (AM) | ANOVA | 0.183 | Superiority or Other (legacy) |
| Change at Week 4 (AM) | ANOVA | 0.440 | Superiority or Other (legacy) |
| Change at Final Week (AM) | ANOVA | 0.838 | Superiority or Other (legacy) |
| Baseline (PM) | ANOVA | 0.096 | Superiority or Other (legacy) |
| Change at Week 1 (PM) | ANOVA | 0.362 | Superiority or Other (legacy) |
| Change at Week 2 (PM) | ANOVA | 0.693 | Superiority or Other (legacy) |
| Change at Week 3 (PM) | ANOVA | 0.603 | Superiority or Other (legacy) |
| Change at Week 4 (PM) | ANOVA | 0.579 | Superiority or Other (legacy) |
| Change at Final Week (PM) | ANOVA | 0.413 | Superiority or Other (legacy) |
| Change at Day 15 |
|
|
| Change at Day 29 |
|
|
| 0.744 |
| Superiority or Other (legacy) |
| Change at Day 29 | ANOVA | 0.675 | Superiority or Other (legacy) |
| Change at Day 15 |
|
|
| Change at Day 29 |
|
|
| 0.818 |
| Superiority or Other (legacy) |
| Change at Day 29 | ANOVA | 0.915 | Superiority or Other (legacy) |
| Change at Day 15 |
|
|
| Change at Day 29 |
|
|
| 0.202 |
| Superiority or Other (legacy) |
| Change at Day 29 | ANOVA | 0.199 | Superiority or Other (legacy) |
| Change at Week 1 |
|
|
| Change at Week 2 |
|
|
| Change at Week 3 |
|
|
| Change at Week 4 |
|
|
| Change at Final Week |
|
|
| 0.710 |
| Superiority or Other (legacy) |
| Change at Week 2 | ANOVA | 0.597 | Superiority or Other (legacy) |
| Change at Week 3 | ANOVA | 0.242 | Superiority or Other (legacy) |
| Change at Week 4 | ANOVA | 0.696 | Superiority or Other (legacy) |
| Change at Final Week | ANOVA | 0.670 | Superiority or Other (legacy) |
| Change at Week 1 |
|
|
| Change at Week 2 |
|
|
| Change at Week 3 |
|
|
| Change at Week 4 |
|
|
| Change at Final Week |
|
|
| 0.025 |
| Superiority or Other (legacy) |
| Change at Week 2 | ANOVA | 0.288 | Superiority or Other (legacy) |
| Change at Week 3 | ANOVA | 0.790 | Superiority or Other (legacy) |
| Change at Week 4 | ANOVA | 0.211 | Superiority or Other (legacy) |
| Change at Final Week | ANOVA | 0.136 | Superiority or Other (legacy) |
| Change at Week 1 |
|
|
| Change at Week 2 |
|
|
| Change at Week 3 |
|
|
| Change at Week 4 |
|
|
| Change at Final Week |
|
|
| 0.656 |
| Superiority or Other (legacy) |
| Change at Week 2 | ANOVA | 0.458 | Superiority or Other (legacy) |
| Change at Week 3 | ANOVA | 0.220 | Superiority or Other (legacy) |
| Change at Week 4 | ANOVA | 0.775 | Superiority or Other (legacy) |
| Change at Final Week | ANOVA | 0.994 | Superiority or Other (legacy) |
| Change at Week 1 |
|
|
| Change at Week 2 |
|
|
| Change at Week 3 |
|
|
| Change at Week 4 |
|
|
| Change at Final Week |
|
|
| 0.262 |
| Superiority or Other (legacy) |
| Change at Week 2 | ANOVA | 0.386 | Superiority or Other (legacy) |
| Change at Week 3 | ANOVA | 0.167 | Superiority or Other (legacy) |
| Change at Week 4 | ANOVA | 0.505 | Superiority or Other (legacy) |
| Change at Final Week | ANOVA | 0.725 | Superiority or Other (legacy) |
| Asthma: Day 29 |
|
|
Stratified by center |
| 0.295 |
| Superiority or Other (legacy) |
| SAR Nasal: Day 29 |
|
|
| Cochran-Mantel-Haenszel |
Stratified by center |
| 0.154 |
| Superiority or Other (legacy) |