A Phase 4 interventional study of Mometasone and Placebo in Rhinitis, Allergic, Seasonal and Asthma, sponsored by Organon and Co. Completed. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Organon and Co · Phase 4, Interventional, and Treatment
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.
396 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's enrollment of 188 is above the median of 136 across 360 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
Drug: Mometasone · Drug: Albuterol/Salbutamol
Matching placebo nasal spray, administered QD for 4 weeks
Drug: Placebo · Drug: Albuterol/Salbutamol
Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.
Also known as: Nasonex
Matching placebo nasal spray, administered QD as 2 sprays in each nostril.
Drug page: Albuterol
Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
Also known as: Proventil HFA
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Mometasone | Placebo |
|---|---|---|
| Started | 113 | 75 |
| Completed | 99 | 68 |
| Not completed | 14 | 7 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Lack of efficacy | 4 | 1 |
| Withdrew: Protocol violation | 8 | 4 |
| Withdrew: Unrelated to study medication | 1 | 0 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 6.5 ± 0.22 | 5.9 ± 0.26 |
| Change at Week 1 (AM) | -0.9 ± 0.20 | -1.4 ± 0.23 |
| Change at Week 2 (AM) | -1.5 ± 0.26 | -1.5 ± 0.30 |
| Change at Week 3 (AM) | -2.4 ± 0.26 | -2.1 ± 0.29 |
| Change at Week 4 (AM) | -2.5 ± 0.27 | -2.6 ± 0.31 |
| Change at Final Week (AM) | -2.2 ± 0.25 | -2.2 ± 0.29 |
| Baseline (PM) | 6.6 ± 0.22 | 6.0 ± 0.26 |
| Change at Week 1 (PM) | -1.4 ± 0.19 | -1.7 ± 0.22 |
| Change at Week 2 (PM) | -1.7 ± 0.24 | -1.7 ± 0.28 |
| Change at Week 3 (PM) | -2.6 ± 0.24 | -2.3 ± 0.28 |
| Change at Week 4 (PM) | -2.7 ± 0.27 | -2.5 ± 0.31 |
| Change at Final Week (PM) | -2.4 ± 0.25 | -2.4 ± 0.29 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 1.7 ± 0.07 | 1.5 ± 0.08 |
| Change at Week 1 (AM) | -0.3 ± 0.05 | -0.3 ± 0.06 |
| Change at Week 2 (AM) | -0.4 ± 0.07 | -0.4 ± 0.08 |
| Change at Week 3 (AM) | -0.7 ± 0.08 | -0.4 ± 0.09 |
| Change at Week 4 (AM) | -0.7 ± 0.08 | -0.5 ± 0.10 |
| Change at Final Week (AM) | -0.6 ± 0.08 | -0.5 ± 0.09 |
| Baseline (PM) | 1.7 ± 0.07 | 1.5 ± 0.08 |
| Change at Week 1 (PM) | -0.4 ± 0.06 | -0.4 ± 0.07 |
| Change at Week 2 (PM) | -0.5 ± 0.07 | -0.4 ± 0.09 |
| Change at Week 3 (PM) | -0.7 ± 0.08 | -0.5 ± 0.09 |
| Change at Week 4 (PM) | -0.7 ± 0.09 | -0.6 ± 0.10 |
| Change at Final Week (PM) | -0.6 ± 0.08 | -0.6 ± 0.09 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 1.5 ± 0.07 | 1.3 ± 0.09 |
| Change at Week 1 (AM) | -0.2 ± 0.05 | -0.3 ± 0.06 |
| Change at Week 2 (AM) | -0.4 ± 0.08 | -0.3 ± 0.09 |
| Change at Week 3 (AM) | -0.6 ± 0.08 | -0.5 ± 0.08 |
| Change at Week 4 (AM) | -0.6 ± 0.08 | -0.6 ± 0.09 |
| Change at Final Week (AM) | -0.5 ± 0.07 | -0.5 ± 0.09 |
| Baseline (PM) | 1.5 ± 0.08 | 1.3 ± 0.09 |
| Change at Week 1 (PM) | -0.3 ± 0.06 | -0.4 ± 0.07 |
| Change at Week 2 (PM) | -0.4 ± 0.07 | -0.4 ± 0.08 |
| Change at Week 3 (PM) | -0.6 ± 0.07 | -0.5 ± 0.08 |
| Change at Week 4 (PM) | -0.7 ± 0.08 | -0.6 ± 0.09 |
| Change at Final Week (PM) | -0.6 ± 0.07 | -0.5 ± 0.09 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 1.7 ± 0.06 | 1.6 ± 0.07 |
| Change at Week 1 (AM) | -0.3 ± 0.06 | -0.3 ± 0.07 |
| Change at Week 2 (AM) | -0.4 ± 0.07 | -0.4 ± 0.08 |
| Change at Week 3 (AM) | -0.7 ± 0.07 | -0.6 ± 0.08 |
| Change at Week 4 (AM) | -0.7 ± 0.07 | -0.7 ± 0.09 |
| Change at Final Week (AM) | -0.6 ± 0.07 | -0.6 ± 0.08 |
| Baseline (PM) | 1.7 ± 0.06 | 1.6 ± 0.07 |
| Change at Week 1 (PM) | -0.3 ± 0.06 | -0.4 ± 0.07 |
| Change at Week 2 (PM) | -0.4 ± 0.06 | -0.5 ± 0.07 |
| Change at Week 3 (PM) | -0.6 ± 0.07 | -0.6 ± 0.08 |
| Change at Week 4 (PM) | -0.7 ± 0.07 | -0.7 ± 0.09 |
| Change at Final Week (PM) | -0.6 ± 0.07 | -0.6 ± 0.08 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 1.6 ± 0.07 | 1.6 ± 0.08 |
| Change at Week 1 (AM) | -0.2 ± 0.06 | -0.4 ± 0.07 |
| Change at Week 2 (AM) | -0.3 ± 0.08 | -0.4 ± 0.09 |
| Change at Week 3 (AM) | -0.5 ± 0.07 | -0.7 ± 0.08 |
| Change at Week 4 (AM) | -0.5 ± 0.07 | -0.7 ± 0.08 |
| Change at Final Week (AM) | -0.4 ± 0.07 | -0.6 ± 0.08 |
| Baseline (PM) | 1.6 ± 0.07 | 1.6 ± 0.08 |
| Change at Week 1 (PM) | -0.3 ± 0.06 | -0.5 ± 0.07 |
| Change at Week 2 (PM) | -0.4 ± 0.07 | -0.5 ± 0.08 |
| Change at Week 3 (PM) | -0.6 ± 0.07 | -0.7 ± 0.08 |
| Change at Week 4 (PM) | -0.6 ± 0.07 | -0.7 ± 0.08 |
| Change at Final Week (PM) | -0.6 ± 0.06 | -0.6 ± 0.08 |
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.
| Participants | Mometasone | Placebo |
|---|---|---|
| Present at Baseline | 11 | 9 |
| Absent at Baseline | 101 | 66 |
| Present on Day 15 | 8 | 4 |
| Absent on Day 15 | 94 | 68 |
| Present on Day 29 | 10 | 3 |
| Absent on Day 29 | 98 | 71 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 8.4 ± 0.19 | 7.9 ± 0.23 |
| Week 1 (AM) | -1.7 ± 0.21 | -0.9 ± 0.25 |
| Week 2 (AM) | -2.3 ± 0.27 | -1.3 ± 0.30 |
| Week 3 (AM) | -3.2 ± 0.29 | -1.8 ± 0.32 |
| Week 4 (AM) | -3.5 ± 0.32 | -2.4 ± 0.37 |
| Final Week (AM) | -3.1 ± 0.29 | -2.2 ± 0.35 |
| Baseline (PM) | 8.2 ± 0.20 | 7.9 ± 0.23 |
| Week 1 (PM) | -1.8 ± 0.22 | -1.5 ± 0.25 |
| Week 2 (PM) | -2.6 ± 0.26 | -1.8 ± 0.30 |
| Week 3 (PM) | -3.4 ± 0.28 | -2.4 ± 0.31 |
| Week 4 (PM) | -3.6 ± 0.31 | -2.8 ± 0.36 |
| Final Week (PM) | -3.3 ± 0.30 | -2.6 ± 0.35 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 2.2 ± 0.06 | 2.1 ± 0.07 |
| Change at Week 1 (AM) | -0.3 ± 0.06 | -0.2 ± 0.07 |
| Change at Week 2 (AM) | -0.5 ± 0.08 | -0.3 ± 0.09 |
| Change at Week 3 (AM) | -0.7 ± 0.09 | -0.4 ± 0.10 |
| Change at Week 4 (AM) | -0.9 ± 0.09 | -0.5 ± 0.11 |
| Change at Final Week (AM) | -0.8 ± 0.09 | -0.5 ± 0.10 |
| Baseline (PM) | 2.1 ± 0.06 | 2.0 ± 0.07 |
| Change at Week 1 (PM) | -0.4 ± 0.06 | -0.3 ± 0.07 |
| Change at Week 2 (PM) | -0.5 ± 0.07 | -0.4 ± 0.08 |
| Change at Week 3 (PM) | -0.8 ± 0.08 | -0.5 ± 0.09 |
| Change at Week 4 (PM) | -0.9 ± 0.09 | -0.6 ± 0.10 |
| Change at Final Week (PM) | -0.8 ± 0.08 | -0.5 ± 0.10 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 2.0 ± 0.07 | 1.9 ± 0.08 |
| Change at Week 1 (AM) | -0.4 ± 0.07 | -0.2 ± 0.08 |
| Change at Week 2 (AM) | -0.6 ± 0.08 | -0.3 ± 0.09 |
| Change at Week 3 (AM) | -0.9 ± 0.08 | -0.5 ± 0.09 |
| Change at Week 4 (AM) | -0.9 ± 0.09 | -0.6 ± 0.11 |
| Change at Final Week (AM) | -0.8 ± 0.09 | -0.5 ± 0.10 |
| Baseline (PM) | 1.7 ± 0.07 | 1.5 ± 0.08 |
| Change at Week 1 (PM) | -0.4 ± 0.06 | -0.3 ± 0.07 |
| Change at Week 2 (PM) | -0.7 ± 0.07 | -0.4 ± 0.09 |
| Change at Week 3 (PM) | -0.9 ± 0.08 | -0.6 ± 0.09 |
| Change at Week 4 (PM) | -0.9 ± 0.09 | -0.7 ± 0.11 |
| Change at Final Week (PM) | -0.8 ± 0.09 | -0.6 ± 0.10 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 1.8 ± 0.07 | 1.7 ± 0.08 |
| Change at Week 1 (AM) | -0.5 ± 0.07 | -0.2 ± 0.08 |
| Change at Week 2 (AM) | -0.6 ± 0.08 | -0.6 ± 0.09 |
| Change at Week 3 (AM) | -0.9 ± 0.08 | -0.4 ± 0.09 |
| Change at Week 4 (AM) | -0.9 ± 0.09 | -0.6 ± 0.10 |
| Change at Final Week (AM) | -0.8 ± 0.08 | -0.6 ± 0.10 |
| Baseline (PM) | 1.9 ± 0.06 | 1.8 ± 0.08 |
| Change at Week 1 (PM) | -0.5 ± 0.07 | -0.4 ± 0.08 |
| Change at Week 2 (PM) | -0.7 ± 0.08 | -0.5 ± 0.09 |
| Change at Week 3 (PM) | -0.9 ± 0.08 | -0.6 ± 0.09 |
| Change at Week 4 (PM) | -0.9 ± 0.09 | -0.7 ± 0.11 |
| Change at Final Week (PM) | -0.9 ± 0.08 | -0.7 ± 0.10 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 2.3 ± 0.05 | 2.3 ± 0.06 |
| Change at Week 1 (AM) | -0.4 ± 0.06 | -0.3 ± 0.07 |
| Change at Week 2 (AM) | -0.5 ± 0.07 | -0.4 ± 0.08 |
| Change at Week 3 (AM) | -0.7 ± 0.08 | -0.5 ± 0.09 |
| Change at Week 4 (AM) | -0.8 ± 0.10 | -0.7 ± 0.11 |
| Change at Final Week (AM) | -0.8 ± 0.08 | -0.6 ± 0.10 |
| Baseline (PM) | 2.2 ± 0.05 | 2.2 ± 0.06 |
| Change at Week 1 (PM) | -0.4 ± 0.07 | -0.4 ± 0.08 |
| Change at Week 2 (PM) | -0.6 ± 0.08 | -0.5 ± 0.09 |
| Change at Week 3 (PM) | -0.8 ± 0.08 | -0.6 ± 0.09 |
| Change at Week 4 (PM) | -0.9 ± 0.09 | -0.8 ± 0.11 |
| Change at Final Week (PM) | -0.8 ± 0.09 | -0.7 ± 0.10 |
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).
| Liters/min | Mometasone | Placebo |
|---|---|---|
| Baseline (AM) | 382.5 ± 8.35 | 362.3 ± 9.97 |
| Change at Week 1 (AM) | 0.9 ± 2.83 | 1.0 ± 3.34 |
| Change at Week 2 (AM) | 4.3 ± 3.28 | 4.1 ± 3.74 |
| Change at Week 3 (AM) | 7.7 ± 3.34 | 1.0 ± 3.73 |
| Change at Week 4 (AM) | 7.8 ± 3.79 | 3.3 ± 4.35 |
| Change at Final Week (AM) | 5.7 ± 3.37 | 4.6 ± 3.97 |
| Baseline (PM) | 394.4 ± 8.18 | 373.4 ± 9.77 |
| Change at Week 1 (PM) | 0.5 ± 2.67 | 4.3 ± 3.15 |
| Change at Week 2 (PM) | 4.9 ± 3.43 | 7.0 ± 3.96 |
| Change at Week 3 (PM) | 5.8 ± 3.70 | 8.7 ± 4.19 |
| Change at Week 4 (PM) | 6.9 ± 4.08 | 10.3 ± 4.69 |
| Change at Final Week (PM) | 5.6 ± 3.58 | 10.1 ± 4.22 |
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.
| Liters | Mometasone | Placebo |
|---|---|---|
| Baseline | 2.98 ± 0.06 | 3.00 ± 0.07 |
| Change at Day 15 | 0.05 ± 0.03 | 0.07 ± 0.04 |
| Change at Day 29 | 0.04 ± 0.04 | 0.02 ± 0.04 |
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.
| Liters | Mometasone | Placebo |
|---|---|---|
| Baseline | 3.75 ± 0.08 | 3.80 ± 0.10 |
| Change at Day 15 | 0.02 ± 0.03 | 0.00 ± 0.04 |
| Change at Day 29 | -0.00 ± 0.04 | 0.00 ± 0.04 |
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.
| Liters/sec | Mometasone | Placebo |
|---|---|---|
| Baseline | 2.98 ± 0.06 | 3.00 ± 0.07 |
| Change at Day 15 | 0.12 ± 0.06 | 0.00 ± 0.07 |
| Change at Day 29 | 0.15 ± 0.06 | 0.03 ± 0.07 |
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).
| Number of puffs | Mometasone | Placebo |
|---|---|---|
| Baseline | 2.4 ± 0.18 | 2.1 ± 0.21 |
| Change at Week 1 | -0.4 ± 0.14 | -0.5 ± 0.17 |
| Change at Week 2 | -0.6 ± 0.16 | -0.5 ± 0.18 |
| Change at Week 3 | -0.8 ± 0.15 | -0.5 ± 0.17 |
| Change at Week 4 | -0.7 ± 0.17 | -0.6 ± 0.19 |
| Change at Final Week | -0.7 ± 0.16 | -0.6 ± 0.19 |
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).
| Awakenings | Mometasone | Placebo |
|---|---|---|
| Baseline | 0.6 ± 0.08 | 0.6 ± 0.09 |
| Change at Week 1 | -0.1 ± 0.05 | -0.2 ± 0.06 |
| Change at Week 2 | -0.1 ± 0.06 | -0.2 ± 0.07 |
| Change at Week 3 | -0.3 ± 0.07 | -0.3 ± 0.08 |
| Change at Week 4 | -0.2 ± 0.07 | -0.3 ± 0.08 |
| Change at Final Week | -0.2 ± 0.06 | -0.3 ± 0.07 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline | 1.3 ± 0.07 | 1.2 ± 0.09 |
| Change at Week 1 | -0.2 ± 0.05 | -0.2 ± 0.06 |
| Change at Week 2 | -0.4 ± 0.07 | -0.3 ± 0.08 |
| Change at Week 3 | -0.5 ± 0.06 | -0.4 ± 0.07 |
| Change at Week 4 | -0.5 ± 0.07 | -0.5 ± 0.08 |
| Change at Final Week | -0.4 ± 0.07 | -0.4 ± 0.08 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Baseline | 1.5 ± 0.06 | 1.4 ± 0.08 |
| Change at Week 1 | -0.3 ± 0.05 | -0.4 ± 0.06 |
| Change at Week 2 | -0.4 ± 0.06 | -0.3 ± 0.07 |
| Change at Week 3 | -0.6 ± 0.07 | -0.4 ± 0.07 |
| Change at Week 4 | -0.6 ± 0.08 | -0.5 ± 0.09 |
| Change at Final Week | -0.5 ± 0.07 | -0.5 ± 0.08 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| Asthma: Day 15 | 3.4 ± 1.13 | 3.4 ± 1.05 |
| Asthma: Day 29 | 3.2 ± 1.26 | 3.5 ± 1.14 |
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).
| Score on a scale | Mometasone | Placebo |
|---|---|---|
| SAR Nasal: Day 15 | 3.2 ± 1.11 | 3.4 ± 1.01 |
| SAR Nasal: Day 29 | 3.0 ± 1.13 | 3.4 ± 1.04 |
Collected over Up to 59 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mometasone | 0/113 (0%) | 1/113 (0.9%) | 4/113 (3.5%) |
| Placebo | 0/75 (0%) | 1/75 (1.3%) | 4/75 (5.3%) |
| Event | Mometasone | Placebo |
|---|---|---|
| PeriodontitisGastrointestinal disorders | 0/113 | 1/75 |
| Fracture, boneInjury, poisoning and procedural complications | 1/113 | 0/75 |
| Event | Mometasone | Placebo |
|---|---|---|
| HeadacheGeneral disorders | 4/113 | 4/75 |
One participant in the mometasone treatment group did not have any post-baseline assessment and was excluded from the Intent-to-Treat (ITT) population, for which baseline demograpic characteristics were summarized.
| Age, Continuous(Years) | Mometasone | Placebo | Total |
|---|---|---|---|
| Mean | 33.3 ± 12.2 | 31.8 ± 10.9 | 32.7 ± 11.6 |
| Sex: Female, Male(Participants) | Mometasone | Placebo | Total |
|---|---|---|---|
| Female | 77 | 55 | 132 |
| Male | 35 | 20 | 55 |
| Race/Ethnicity, Customized(Participants) | Mometasone | Placebo | Total |
|---|---|---|---|
| White | 83 | 60 | 143 |
| Black or African American | 22 | 8 | 30 |
| Hispanic | 5 | 6 | 11 |
| Asian | 1 | 1 | 2 |
| Other | 1 | 0 | 1 |
No study locations are listed for this record.
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Studies of the drug tested here: Mometasone Furoate
Rhinitis, Allergic, Seasonal →