Rhinitis, Allergic, Seasonal, Asthma
Conditions
Keywords
Seasonal Allergic Rhinitis, Asthma
Brief summary
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.
Interventions
DRUGAlbuterol/Salbutamol
Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
DRUGMometasone
Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.
DRUGPlacebo
Matching placebo nasal spray, administered QD as 2 sprays in each nostril.
Sponsors
Integrated Therapeutics Group
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have at least a two-year history of seasonal allergic rhinitis and an increase in asthma symptoms associated with the allergy season under study * Demonstrate an increase in absolute FEV 1 less than 12%, with an absolute volume increase of at least 200 ml, after reversibility testing within the past 12 months * Is skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at screening, or within 12 months prior to the screening visit, to a seasonal allergen (which may include seasonal molds) prevalent during the study period. * Female participants of childbearing potential use a medically accepted method of birth control and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Females who are not sexually active at time of study agree and consent to use a medically acceptable method of birth control should they become sexually active while participating in the study.
Exclusion criteria
* Female participants who are pregnant, intend to become pregnant during the duration of the study, or are nursing. * Have asthma symptoms and require chronic use of inhaled or systemic corticosteroids. * Have current or historical frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip. * Have recent nasal septum ulcers, nasal surgery or nasal trauma, which should not be included until healing occurs. * Have rhinitis medicamentosa or chronic obstructive pulmonary disease (COPD). * Have an upper or lower respiratory tract or sinus infection that requires antibiotic therapy, or have a viral upper or lower respiratory infection. * Have nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interferes with nasal air flow. * Are dependent on nasal topical antihistamines, or nasal steroids. * On immunotherapy (desensitization therapy) and will receive an increase in dose during the study; participants who will receive desensitization treatment within 24 hours prior to a study visit. * Is a participant who smokes, or is an ex-smoker who has smoked within the previous six months. * Is an investigator, study staff member, or family member involved with this study. * Has active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, or systemic viral infections, or herpes simplex. * Is a participant whose ability to provide informed consent is compromised. * Has a history of non-compliance with medications or treatment protocols. * Is morbidly obese (BMI \>35). * Is a night-shift worker or does not have a standard asleep at night/awake during the day cycle. * Has any history of life-threatening asthma attacks or is treated in the emergency room or admitted to the hospital for asthma control within the previous 3 months or more than once in the previous 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Baseline up to Week 4 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AM and PM Wheeze Symptom Score | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Chest Tightness Symptom Score | Baseline up to Week 4 | 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). |
| Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Baseline, Day 15 and Day 29 | 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. |
| Change From Baseline in Weekly Average Interference With Daily Activities | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Rhinorrhea Symptom Score | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Nasal Itching Symptom Score | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Cough Symptom Score | Baseline up to Week 4 | 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). |
| Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Baseline up to Week 4 | 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). |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline, Day 15 and Day 29 | 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. |
| Change From Baseline in Forced Vital Capacity (FVC) | Baseline, Day 15 and Day 29 | 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. |
| Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Baseline, Day 15 and Day 29 | 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. |
| Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Baseline up to Week 4 | 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). |
| Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Baseline up to Week 4 | 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). |
| Change From Baseline in Weekly Average Interference With Sleep | Baseline up to Week 4 | 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). |
| Therapeutic Response to Asthma Symptoms | Day 15 and Day 29 | 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). |
| Therapeutic Response to SAR Nasal Symptoms | Day 15 and Day 29 | 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). |
| Change From Baseline in AM and PM Nasal Congestion Symptom Score | Baseline up to Week 4 | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks | 112 |
| Placebo Matching placebo nasal spray, administered QD for 4 weeks | 75 |
| Total | 187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lack of Efficacy | 4 | 1 |
| Overall Study | Protocol Violation | 8 | 4 |
| Overall Study | Unrelated to Study Medication | 1 | 0 |
Baseline characteristics
| Characteristic | Mometasone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33.3 Years STANDARD_DEVIATION 12.2 | 31.8 Years STANDARD_DEVIATION 10.9 | 32.7 Years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 22 Participants | 8 Participants | 30 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 83 Participants | 60 Participants | 143 Participants |
| Sex: Female, Male Female | 77 Participants | 55 Participants | 132 Participants |
| Sex: Female, Male Male | 35 Participants | 20 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 75 |
| other Total, other adverse events | 4 / 113 | 4 / 75 |
| serious Total, serious adverse events | 1 / 113 | 1 / 75 |
Outcome results
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Baseline (AM) | 6.5 Score on a scale | Standard Error 0.22 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 1 (AM) | -0.9 Score on a scale | Standard Error 0.2 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 2 (AM) | -1.5 Score on a scale | Standard Error 0.26 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 3 (AM) | -2.4 Score on a scale | Standard Error 0.26 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 4 (AM) | -2.5 Score on a scale | Standard Error 0.27 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Final Week (AM) | -2.2 Score on a scale | Standard Error 0.25 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Baseline (PM) | 6.6 Score on a scale | Standard Error 0.22 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 1 (PM) | -1.4 Score on a scale | Standard Error 0.19 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 2 (PM) | -1.7 Score on a scale | Standard Error 0.24 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 3 (PM) | -2.6 Score on a scale | Standard Error 0.24 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 4 (PM) | -2.7 Score on a scale | Standard Error 0.27 |
| Mometasone | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Final Week (PM) | -2.4 Score on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 4 (PM) | -2.5 Score on a scale | Standard Error 0.31 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Baseline (AM) | 5.9 Score on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Baseline (PM) | 6.0 Score on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 1 (AM) | -1.4 Score on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 3 (PM) | -2.3 Score on a scale | Standard Error 0.28 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 2 (AM) | -1.5 Score on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 1 (PM) | -1.7 Score on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 3 (AM) | -2.1 Score on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Final Week (PM) | -2.4 Score on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 4 (AM) | -2.6 Score on a scale | Standard Error 0.31 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Week 2 (PM) | -1.7 Score on a scale | Standard Error 0.28 |
| Placebo | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) | Change at Final Week (AM) | -2.2 Score on a scale | Standard Error 0.29 |
Comparison: Baseline (AM)p-value: 0.101ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.168ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.93ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.487ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.914ANOVA
Comparison: Change at Final Week (AM)p-value: 0.977ANOVA
Comparison: Baseline (PM)p-value: 0.109ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.291ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.984ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.373ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.623ANOVA
Comparison: Change at Final Week (PM)p-value: 0.978ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 2 (AM) | -0.3 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 1 (PM) | -0.3 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 4 (AM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 2 (PM) | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 1 (AM) | -0.2 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 3 (PM) | -0.6 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Final Week (AM) | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 4 (PM) | -0.6 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 3 (AM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Baseline (PM) | 1.6 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Chest Tightness Symptom Score | Baseline (AM) | 1.6 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Baseline (PM) | 1.6 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 1 (AM) | -0.4 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 2 (AM) | -0.4 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 3 (AM) | -0.7 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 4 (AM) | -0.7 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Final Week (AM) | -0.6 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Baseline (AM) | 1.6 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 1 (PM) | -0.5 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 2 (PM) | -0.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 3 (PM) | -0.7 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Week 4 (PM) | -0.7 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Chest Tightness Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.08 |
Comparison: Change at Week 1 (AM)p-value: 0.038ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.182ANOVA
Comparison: Baseline (AM)p-value: 0.629ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.149ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.035ANOVA
Comparison: Change at Final Week (AM)p-value: 0.056ANOVA
Comparison: Baseline (PM)p-value: 0.711ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.098ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.356ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.529ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.617ANOVA
Comparison: Change at Final Week (PM)p-value: 0.422ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Baseline (AM) | 1.7 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 1 (AM) | -0.3 Score on a scale | Standard Error 0.05 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 2 (AM) | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 3 (AM) | -0.7 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 4 (AM) | -0.7 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Final Week (AM) | -0.6 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Baseline (PM) | 1.7 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 2 (PM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 3 (PM) | -0.7 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 4 (PM) | -0.7 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Cough Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 4 (PM) | -0.6 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Baseline (AM) | 1.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Baseline (PM) | 1.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 1 (AM) | -0.3 Score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 3 (PM) | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 2 (AM) | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 3 (AM) | -0.4 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 4 (AM) | -0.5 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Week 2 (PM) | -0.4 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Cough Symptom Score | Change at Final Week (AM) | -0.5 Score on a scale | Standard Error 0.09 |
Comparison: Baseline (AM)p-value: 0.023ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.693ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.483ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.088ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.21ANOVA
Comparison: Change at Final Week (AM)p-value: 0.178ANOVA
Comparison: Baseline (PM)p-value: 0.055ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.915ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.471ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.11ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.305ANOVA
Comparison: Change at Final Week (PM)p-value: 0.461ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Baseline (AM) | 1.7 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 1 (AM) | -0.3 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 2 (AM) | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 3 (AM) | -0.7 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 4 (AM) | -0.7 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Final Week (AM) | -0.6 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Baseline (PM) | 1.7 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 1 (PM) | -0.3 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 2 (PM) | -0.4 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 3 (PM) | -0.6 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 4 (PM) | -0.7 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 4 (PM) | -0.7 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Baseline (AM) | 1.6 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Baseline (PM) | 1.6 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 1 (AM) | -0.3 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 3 (PM) | -0.6 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 2 (AM) | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 3 (AM) | -0.6 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 4 (AM) | -0.7 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Week 2 (PM) | -0.5 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Difficulty Breathing Symptom Score | Change at Final Week (AM) | -0.6 Score on a scale | Standard Error 0.08 |
Comparison: Baseline (AM)p-value: 0.078ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.492ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.945ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.359ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.802ANOVA
Comparison: Change at Final Week (AM)p-value: 0.716ANOVA
Comparison: Baseline (PM)p-value: 0.158ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.281ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.901ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.433ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.73ANOVA
Comparison: Change at Final Week (PM)p-value: 0.819ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Baseline (AM) | 2.3 Score on a scale | Standard Error 0.05 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 1 (AM) | -0.4 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 2 (AM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 3 (AM) | -0.7 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 4 (AM) | -0.8 Score on a scale | Standard Error 0.1 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Final Week (AM) | -0.8 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Baseline (PM) | 2.2 Score on a scale | Standard Error 0.05 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 2 (PM) | -0.6 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 3 (PM) | -0.8 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 4 (PM) | -0.9 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Final Week (PM) | -0.8 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 4 (PM) | -0.8 Score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Baseline (AM) | 2.3 Score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Baseline (PM) | 2.2 Score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 1 (AM) | -0.3 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 3 (PM) | -0.6 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 2 (AM) | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 3 (AM) | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Final Week (PM) | -0.7 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 4 (AM) | -0.7 Score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Week 2 (PM) | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Congestion Symptom Score | Change at Final Week (AM) | -0.6 Score on a scale | Standard Error 0.1 |
Comparison: Baseline (AM)p-value: 0.745ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.25ANOVA
p-value: 0.202ANOVA
p-value: 0.104ANOVA
p-value: 0.348ANOVA
p-value: 0.355ANOVA
p-value: 0.851ANOVA
p-value: 0.993ANOVA
p-value: 0.476ANOVA
p-value: 0.149ANOVA
p-value: 0.616ANOVA
p-value: 0.527ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 4 (AM) | -0.9 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Baseline (AM) | 2.0 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 1 (AM) | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 2 (AM) | -0.6 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 3 (AM) | -0.9 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Final Week (AM) | -0.8 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Baseline (PM) | 1.7 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 2 (PM) | -0.7 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 3 (PM) | -0.9 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 4 (PM) | -0.9 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Final Week (PM) | -0.8 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 4 (PM) | -0.7 Score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Baseline (PM) | 1.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Baseline (AM) | 1.9 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 3 (PM) | -0.6 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 1 (AM) | -0.2 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 1 (PM) | -0.3 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 2 (AM) | -0.3 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 3 (AM) | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 4 (AM) | -0.6 Score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Week 2 (PM) | -0.4 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Itching Symptom Score | Change at Final Week (AM) | -0.5 Score on a scale | Standard Error 0.1 |
Comparison: Baseline (AM)p-value: 0.181ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.014ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.004ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.002ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.027ANOVA
Comparison: Change at Final Week (AM)p-value: 0.069ANOVA
Comparison: Baseline (PM)p-value: 0.373ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.148ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.009ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.016ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.113ANOVA
Comparison: Change at Final Week (PM)p-value: 0.173ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 2 (AM) | -0.6 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 1 (PM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 4 (AM) | -0.9 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 2 (PM) | -0.7 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 1 (AM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 3 (PM) | -0.9 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Final Week (AM) | -0.8 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 4 (PM) | -0.9 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 3 (AM) | -0.9 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Final Week (PM) | -0.9 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Baseline (PM) | 1.9 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Baseline (AM) | 1.8 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Baseline (PM) | 1.8 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 1 (AM) | -0.2 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 2 (AM) | -0.6 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 3 (AM) | -0.4 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 4 (AM) | -0.6 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Final Week (AM) | -0.6 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Baseline (AM) | 1.7 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 2 (PM) | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 3 (PM) | -0.6 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Week 4 (PM) | -0.7 Score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in AM and PM Nasal Sneezing Symptom Score | Change at Final Week (PM) | -0.7 Score on a scale | Standard Error 0.1 |
Comparison: Baseline (AM)p-value: 0.089ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.014ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.004ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.001ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.041ANOVA
Comparison: Change at Final Week (AM)p-value: 0.036ANOVA
Comparison: Baseline (PM)p-value: 0.17ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.237ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.019ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.018ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.149ANOVA
Comparison: Change at Final Week (PM)p-value: 0.231ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Baseline (AM) | 382.5 Liters/min | Standard Error 8.35 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 1 (AM) | 0.9 Liters/min | Standard Error 2.83 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 2 (AM) | 4.3 Liters/min | Standard Error 3.28 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 3 (AM) | 7.7 Liters/min | Standard Error 3.34 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 4 (AM) | 7.8 Liters/min | Standard Error 3.79 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Final Week (AM) | 5.7 Liters/min | Standard Error 3.37 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Baseline (PM) | 394.4 Liters/min | Standard Error 8.18 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 1 (PM) | 0.5 Liters/min | Standard Error 2.67 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 2 (PM) | 4.9 Liters/min | Standard Error 3.43 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 3 (PM) | 5.8 Liters/min | Standard Error 3.7 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 4 (PM) | 6.9 Liters/min | Standard Error 4.08 |
| Mometasone | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Final Week (PM) | 5.6 Liters/min | Standard Error 3.58 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 4 (PM) | 10.3 Liters/min | Standard Error 4.69 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Baseline (AM) | 362.3 Liters/min | Standard Error 9.97 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Baseline (PM) | 373.4 Liters/min | Standard Error 9.77 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 1 (AM) | 1.0 Liters/min | Standard Error 3.34 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 3 (PM) | 8.7 Liters/min | Standard Error 4.19 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 2 (AM) | 4.1 Liters/min | Standard Error 3.74 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 1 (PM) | 4.3 Liters/min | Standard Error 3.15 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 3 (AM) | 1.0 Liters/min | Standard Error 3.73 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Final Week (PM) | 10.1 Liters/min | Standard Error 4.22 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 4 (AM) | 3.3 Liters/min | Standard Error 4.35 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Week 2 (PM) | 7.0 Liters/min | Standard Error 3.96 |
| Placebo | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) | Change at Final Week (AM) | 4.6 Liters/min | Standard Error 3.97 |
Comparison: Baseline (AM)p-value: 0.116ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.994ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.961ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.183ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.44ANOVA
Comparison: Change at Final Week (AM)p-value: 0.838ANOVA
Comparison: Baseline (PM)p-value: 0.096ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.362ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.693ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.603ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.579ANOVA
Comparison: Change at Final Week (PM)p-value: 0.413ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Baseline (AM) | 2.2 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 1 (AM) | -0.3 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 2 (AM) | -0.5 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 3 (AM) | -0.7 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 4 (AM) | -0.9 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Final Week (AM) | -0.8 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Baseline (PM) | 2.1 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 2 (PM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 3 (PM) | -0.8 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 4 (PM) | -0.9 Score on a scale | Standard Error 0.09 |
| Mometasone | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Final Week (PM) | -0.8 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 4 (PM) | -0.6 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Baseline (AM) | 2.1 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Baseline (PM) | 2.0 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 1 (AM) | -0.2 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 3 (PM) | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 2 (AM) | -0.3 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 1 (PM) | -0.3 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 3 (AM) | -0.4 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Final Week (PM) | -0.5 Score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 4 (AM) | -0.5 Score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Week 2 (PM) | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Rhinorrhea Symptom Score | Change at Final Week (AM) | -0.5 Score on a scale | Standard Error 0.1 |
Comparison: Baseline (AM)p-value: 0.136ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.126ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.107ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.006ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.03ANOVA
Comparison: Change at Final Week (AM)p-value: 0.037ANOVA
Comparison: Baseline (PM)p-value: 0.146ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.426ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.259ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.026ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.022ANOVA
Comparison: Change at Final Week (PM)p-value: 0.043ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 1 (AM) | -1.7 Score on a scale | Standard Error 0.21 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Baseline (PM) | 8.2 Score on a scale | Standard Error 0.2 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 1 (PM) | -1.8 Score on a scale | Standard Error 0.22 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 3 (AM) | -3.2 Score on a scale | Standard Error 0.29 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 2 (PM) | -2.6 Score on a scale | Standard Error 0.26 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Baseline (AM) | 8.4 Score on a scale | Standard Error 0.19 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 3 (PM) | -3.4 Score on a scale | Standard Error 0.28 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 4 (AM) | -3.5 Score on a scale | Standard Error 0.32 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 4 (PM) | -3.6 Score on a scale | Standard Error 0.31 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 2 (AM) | -2.3 Score on a scale | Standard Error 0.27 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Final Week (PM) | -3.3 Score on a scale | Standard Error 0.3 |
| Mometasone | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Final Week (AM) | -3.1 Score on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Final Week (PM) | -2.6 Score on a scale | Standard Error 0.35 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Baseline (AM) | 7.9 Score on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 1 (AM) | -0.9 Score on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 2 (AM) | -1.3 Score on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 3 (AM) | -1.8 Score on a scale | Standard Error 0.32 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 4 (AM) | -2.4 Score on a scale | Standard Error 0.37 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Final Week (AM) | -2.2 Score on a scale | Standard Error 0.35 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 1 (PM) | -1.5 Score on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 2 (PM) | -1.8 Score on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 3 (PM) | -2.4 Score on a scale | Standard Error 0.31 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Week 4 (PM) | -2.8 Score on a scale | Standard Error 0.36 |
| Placebo | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) | Baseline (PM) | 7.9 Score on a scale | Standard Error 0.23 |
Comparison: Baseline (AM)p-value: 0.104ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.022ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.012ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.001ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.033ANOVA
Comparison: Change at Final Week (AM)p-value: 0.047ANOVA
Comparison: Baseline (PM)p-value: 0.269ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.308ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.05ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.014ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.1ANOVA
Comparison: Change at Final Week (PM)p-value: 0.139ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Baseline (AM) | 1.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 1 (AM) | -0.2 Score on a scale | Standard Error 0.05 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 2 (AM) | -0.4 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 3 (AM) | -0.6 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 4 (AM) | -0.6 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Final Week (AM) | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Baseline (PM) | 1.5 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 1 (PM) | -0.3 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 2 (PM) | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 3 (PM) | -0.6 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 4 (PM) | -0.7 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Final Week (PM) | -0.6 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 4 (PM) | -0.6 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Baseline (AM) | 1.3 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Baseline (PM) | 1.3 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 1 (AM) | -0.3 Score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 3 (PM) | -0.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 2 (AM) | -0.3 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 1 (PM) | -0.4 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 3 (AM) | -0.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Final Week (PM) | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 4 (AM) | -0.6 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Week 2 (PM) | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in AM and PM Wheeze Symptom Score | Change at Final Week (AM) | -0.5 Score on a scale | Standard Error 0.09 |
Comparison: Baseline (AM)p-value: 0.068ANOVA
Comparison: Change at Week 1 (AM)p-value: 0.116ANOVA
Comparison: Change at Week 2 (AM)p-value: 0.749ANOVA
Comparison: Change at Week 3 (AM)p-value: 0.289ANOVA
Comparison: Change at Week 4 (AM)p-value: 0.982ANOVA
Comparison: Change at Final Week (AM)p-value: 0.941ANOVA
Comparison: Baseline (PM)p-value: 0.128ANOVA
Comparison: Change at Week 1 (PM)p-value: 0.484ANOVA
Comparison: Change at Week 2 (PM)p-value: 0.673ANOVA
Comparison: Change at Week 3 (PM)p-value: 0.25ANOVA
Comparison: Change at Week 4 (PM)p-value: 0.45ANOVA
Comparison: Change at Final Week (PM)p-value: 0.774ANOVA
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.
Time frame: Baseline, Day 15 and Day 29
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Baseline | 2.98 Liters/sec | Standard Error 0.06 |
| Mometasone | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Change at Day 15 | 0.12 Liters/sec | Standard Error 0.06 |
| Mometasone | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Change at Day 29 | 0.15 Liters/sec | Standard Error 0.06 |
| Placebo | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Change at Day 29 | 0.03 Liters/sec | Standard Error 0.07 |
| Placebo | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Baseline | 3.00 Liters/sec | Standard Error 0.07 |
| Placebo | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) | Change at Day 15 | 0.00 Liters/sec | Standard Error 0.07 |
Comparison: Baselinep-value: 0.823ANOVA
Comparison: Change at Day 15p-value: 0.202ANOVA
Comparison: Change at Day 29p-value: 0.199ANOVA
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.
Time frame: Baseline, Day 15 and Day 29
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 2.98 Liters | Standard Error 0.06 |
| Mometasone | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Change at Day 15 | 0.05 Liters | Standard Error 0.03 |
| Mometasone | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Change at Day 29 | 0.04 Liters | Standard Error 0.04 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 3.00 Liters | Standard Error 0.07 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Change at Day 15 | 0.07 Liters | Standard Error 0.04 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Change at Day 29 | 0.02 Liters | Standard Error 0.04 |
Comparison: Baselinep-value: 0.823ANOVA
Comparison: Change at Day 15p-value: 0.744ANOVA
Comparison: Change at Day 29p-value: 0.675ANOVA
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.
Time frame: Baseline, Day 15 and Day 29
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.75 Liters | Standard Error 0.08 |
| Mometasone | Change From Baseline in Forced Vital Capacity (FVC) | Change at Day 15 | 0.02 Liters | Standard Error 0.03 |
| Mometasone | Change From Baseline in Forced Vital Capacity (FVC) | Change at Day 29 | -0.00 Liters | Standard Error 0.04 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.80 Liters | Standard Error 0.1 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Change at Day 15 | 0.00 Liters | Standard Error 0.04 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Change at Day 29 | 0.00 Liters | Standard Error 0.04 |
Comparison: Baselinep-value: 0.693ANOVA
Comparison: Change at Day 15p-value: 0.818ANOVA
Comparison: Change at Day 29p-value: 0.915ANOVA
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.
Time frame: Baseline, Day 15 and Day 29
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mometasone | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Present at Baseline | 11 Participants |
| Mometasone | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Absent at Baseline | 101 Participants |
| Mometasone | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Present on Day 15 | 8 Participants |
| Mometasone | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Absent on Day 15 | 94 Participants |
| Mometasone | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Present on Day 29 | 10 Participants |
| Mometasone | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Absent on Day 29 | 98 Participants |
| Placebo | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Present on Day 29 | 3 Participants |
| Placebo | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Present at Baseline | 9 Participants |
| Placebo | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Absent on Day 15 | 68 Participants |
| Placebo | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Absent at Baseline | 66 Participants |
| Placebo | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Absent on Day 29 | 71 Participants |
| Placebo | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment | Present on Day 15 | 4 Participants |
p-value: 0.532Cochran-Mantel-Haenszel
p-value: 0.739Cochran-Mantel-Haenszel
p-value: 0.227Cochran-Mantel-Haenszel
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Baseline | 2.4 Number of puffs | Standard Error 0.18 |
| Mometasone | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 1 | -0.4 Number of puffs | Standard Error 0.14 |
| Mometasone | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 2 | -0.6 Number of puffs | Standard Error 0.16 |
| Mometasone | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 3 | -0.8 Number of puffs | Standard Error 0.15 |
| Mometasone | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 4 | -0.7 Number of puffs | Standard Error 0.17 |
| Mometasone | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Final Week | -0.7 Number of puffs | Standard Error 0.16 |
| Placebo | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 4 | -0.6 Number of puffs | Standard Error 0.19 |
| Placebo | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Baseline | 2.1 Number of puffs | Standard Error 0.21 |
| Placebo | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 3 | -0.5 Number of puffs | Standard Error 0.17 |
| Placebo | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 1 | -0.5 Number of puffs | Standard Error 0.17 |
| Placebo | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Final Week | -0.6 Number of puffs | Standard Error 0.19 |
| Placebo | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used | Change at Week 2 | -0.5 Number of puffs | Standard Error 0.18 |
Comparison: Baselinep-value: 0.375ANOVA
Comparison: Change at Week 1p-value: 0.71ANOVA
Comparison: Change at Week 2p-value: 0.597ANOVA
Comparison: Change at Week 3p-value: 0.242ANOVA
Comparison: Change at Week 4p-value: 0.696ANOVA
Comparison: Change at Final Weekp-value: 0.67ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in Weekly Average Interference With Daily Activities | Baseline | 1.5 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 1 | -0.3 Score on a scale | Standard Error 0.05 |
| Mometasone | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 2 | -0.4 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 3 | -0.6 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 4 | -0.6 Score on a scale | Standard Error 0.08 |
| Mometasone | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Final Week | -0.5 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 4 | -0.5 Score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in Weekly Average Interference With Daily Activities | Baseline | 1.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 3 | -0.4 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 1 | -0.4 Score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Final Week | -0.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Weekly Average Interference With Daily Activities | Change at Week 2 | -0.3 Score on a scale | Standard Error 0.07 |
Comparison: Baselinep-value: 0.363ANOVA
Comparison: Change at Week 1p-value: 0.262ANOVA
Comparison: Change at Week 2p-value: 0.386ANOVA
Comparison: Change at Week 3p-value: 0.167ANOVA
Comparison: Change at Week 4p-value: 0.505ANOVA
Comparison: Change at Final Weekp-value: 0.725ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 3 | -0.5 Score on a scale | Standard Error 0.06 |
| Mometasone | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 4 | -0.5 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in Weekly Average Interference With Sleep | Baseline | 1.3 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in Weekly Average Interference With Sleep | Change at Final Week | -0.4 Score on a scale | Standard Error 0.07 |
| Mometasone | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 1 | -0.2 Score on a scale | Standard Error 0.05 |
| Mometasone | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 2 | -0.4 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 1 | -0.2 Score on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 2 | -0.3 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 3 | -0.4 Score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Weekly Average Interference With Sleep | Change at Week 4 | -0.5 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Weekly Average Interference With Sleep | Change at Final Week | -0.4 Score on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in Weekly Average Interference With Sleep | Baseline | 1.2 Score on a scale | Standard Error 0.09 |
Comparison: Baselinep-value: 0.667ANOVA
Comparison: Change at Week 1p-value: 0.656ANOVA
Comparison: Change at Week 2p-value: 0.458ANOVA
Comparison: Change at Week 3p-value: 0.22ANOVA
Comparison: Change at Week 4p-value: 0.775ANOVA
Comparison: Change at Final Weekp-value: 0.994ANOVA
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).
Time frame: Baseline up to Week 4
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 2 | -0.1 Awakenings | Standard Error 0.06 |
| Mometasone | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Baseline | 0.6 Awakenings | Standard Error 0.08 |
| Mometasone | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 1 | -0.1 Awakenings | Standard Error 0.05 |
| Mometasone | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 3 | -0.3 Awakenings | Standard Error 0.07 |
| Mometasone | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 4 | -0.2 Awakenings | Standard Error 0.07 |
| Mometasone | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Final Week | -0.2 Awakenings | Standard Error 0.06 |
| Placebo | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 4 | -0.3 Awakenings | Standard Error 0.08 |
| Placebo | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 3 | -0.3 Awakenings | Standard Error 0.08 |
| Placebo | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Baseline | 0.6 Awakenings | Standard Error 0.09 |
| Placebo | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Final Week | -0.3 Awakenings | Standard Error 0.07 |
| Placebo | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 1 | -0.2 Awakenings | Standard Error 0.06 |
| Placebo | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma | Change at Week 2 | -0.2 Awakenings | Standard Error 0.07 |
Comparison: Baselinep-value: 0.865ANOVA
Comparison: Change at Week 1p-value: 0.025ANOVA
Comparison: Change at Week 2p-value: 0.288ANOVA
Comparison: Change at Week 3p-value: 0.79ANOVA
Comparison: Change at Week 4p-value: 0.211ANOVA
Comparison: Change at Final Weekp-value: 0.136ANOVA
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).
Time frame: Day 15 and Day 29
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Therapeutic Response to Asthma Symptoms | Asthma: Day 15 | 3.4 Score on a scale | Standard Deviation 1.13 |
| Mometasone | Therapeutic Response to Asthma Symptoms | Asthma: Day 29 | 3.2 Score on a scale | Standard Deviation 1.26 |
| Placebo | Therapeutic Response to Asthma Symptoms | Asthma: Day 15 | 3.4 Score on a scale | Standard Deviation 1.05 |
| Placebo | Therapeutic Response to Asthma Symptoms | Asthma: Day 29 | 3.5 Score on a scale | Standard Deviation 1.14 |
Comparison: Asthma Symptoms: Day 15p-value: 0.954Cochran-Mantel-Haenszel
Comparison: Asthma Symptoms: Day 29p-value: 0.295Cochran-Mantel-Haenszel
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).
Time frame: Day 15 and Day 29
Population: All randomized participants who had at least one post-baseline assessment at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone | Therapeutic Response to SAR Nasal Symptoms | SAR Nasal: Day 15 | 3.2 Score on a scale | Standard Deviation 1.11 |
| Mometasone | Therapeutic Response to SAR Nasal Symptoms | SAR Nasal: Day 29 | 3.0 Score on a scale | Standard Deviation 1.13 |
| Placebo | Therapeutic Response to SAR Nasal Symptoms | SAR Nasal: Day 15 | 3.4 Score on a scale | Standard Deviation 1.01 |
| Placebo | Therapeutic Response to SAR Nasal Symptoms | SAR Nasal: Day 29 | 3.4 Score on a scale | Standard Deviation 1.04 |
Comparison: SAR Nasal Symptoms: Day 15p-value: 0.268Cochran-Mantel-Haenszel
Comparison: SAR Nasal Symptoms: Day 29p-value: 0.154Cochran-Mantel-Haenszel