A Phase 3 interventional study of mometasone furoate and Placebo in Seasonal Allergic Rhinitis, sponsored by Organon and Co. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 426 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: mometasone furoate
Drug: Placebo
50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning
Also known as: Nasonex, SCH 32088
Two sprays in each nostril once daily in the morning
Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.
Time frame: Baseline and 15 days
Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.
Time frame: Baseline and 15 days
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.
Time frame: Baseline and 15 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.
Time frame: Baseline and 15 days
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.
Time frame: Baseline and 15 days
| Milestone | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|
| Started | 211 | 215 |
| Completed | 208 | 212 |
| Not completed | 3 | 3 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.
| units on a scale | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|
| Baseline TNSS | 9.83 ± 1.56 | 9.69 ± 1.56 |
| Change from Baseline in TNSS | -2.36 ± 2.07 | -1.71 ± 2.07 |
TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.
| units on a scale | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|
| Baseline TOSS | 7.07 ± 1.54 | 7.01 ± 1.54 |
| Change from Baseline in TOSS | -1.52 ± 1.59 | -1.36 ± 1.59 |
Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.
| units on a scale | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|
| Baseline Nasal Congestion Score | 2.66 ± 0.40 | 2.64 ± 0.40 |
| Change from Baseline in Nasal Congestion Score | -0.54 ± 0.54 | -0.39 ± 0.54 |
The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.
| units on a scale | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|
| Baseline RQLQ Total Score | 4.19 ± 0.97 | 4.42 ± 0.97 |
| Change from Baseline in RQLQ Total Score | -1.63 ± 1.37 | -1.36 ± 1.37 |
Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.
| liters/minute | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|
| Baseline PNIF | 89.11 ± 37.2 | 88.85 ± 37.2 |
| Change from Baseline in PNIF | 10.15 ± 21.1 | 8.24 ± 21.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | — | 0/211 (0%) | 0/211 (0%) |
| Placebo | — | 0/215 (0%) | 0/215 (0%) |
| Age, Categorical(Participants) | Mometasone Furoate Nasal Spray (MFNS) | Placebo | Total |
|---|---|---|---|
| <=18 years | 18 | 30 | 48 |
| Between 18 and 65 years | 188 | 181 | 369 |
| >=65 years | 5 | 4 | 9 |
| Sex: Female, Male(Participants) | Mometasone Furoate Nasal Spray (MFNS) | Placebo | Total |
|---|---|---|---|
| Female | 140 | 130 | 270 |
| Male | 71 | 85 | 156 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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