A Phase 4 interventional study of Mometasone Furoate Nasal Spray and Placebo in Seasonal Allergic Rhinitis, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Organon and Co · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 310 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:
MFNS 200 mcg total dose (2 sprays each nostril)
Drug: Mometasone Furoate Nasal Spray
Placebo (2 sprays each nostril)
Other: Placebo
Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
Also known as: SCH 032088
Placebo: 2 sprays in each nostril
Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1
Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea \& itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, \& disturbing some of the time; 3=Severe: sign/symptom very noticeable \& very bothersome most of the time.
Time frame: Baseline and 6 hours following initial dosing
| Milestone | Mometasone Furoate Nasal Spray Day 1 | Placebo Day 1 | Mometasone Furoate Nasal Spray Day 8 | Placebo Day 8 |
|---|---|---|---|---|
| Started | 77 | 78 | 78 | 77 |
| Completed | 77 | 77 | 74 | 73 |
| Not completed | 0 | 1 | 4 | 4 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 2 |
| Withdrew: Protocol violation | 0 | 0 | 3 | 2 |
Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea \& itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, \& disturbing some of the time; 3=Severe: sign/symptom very noticeable \& very bothersome most of the time.
| score on a scale | Mometasone Furoate Nasal Spray 200 mcg | Placebo |
|---|---|---|
| Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 | -2.01 ± 0.23 | -1.86 ± 0.23 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mometasone Furoate Nasal Spray Day 1 | — | 0/77 (0%) | 1/77 (1.3%) |
| Placebo Day 1 | — | 0/78 (0%) | 1/78 (1.3%) |
| Mometasone Furoate Nasal Spray Day 8 | — | 0/78 (0%) | 6/78 (7.7%) |
| Placebo Day 8 | — | 0/77 (0%) | 4/77 (5.2%) |
| Event | Mometasone Furoate Nasal Spray Day 1 | Placebo Day 1 | Mometasone Furoate Nasal Spray Day 8 | Placebo Day 8 |
|---|---|---|---|---|
| HeadacheNervous system disorders | 1/77 | 1/78 | 6/78 | 4/77 |
| Age, Continuous(years) | Mometasone Furoate Nasal Spray Day 1 | Placebo Day 1 | Mometasone Furoate Nasal Spray Day 8 | Placebo Day 8 | Total |
|---|---|---|---|---|---|
| Mean | 38.3 ± 11.1 | 36.3 ± 10.1 | 36.9 ± 10.2 | 38.9 ± 11.2 | 37.6 ± 10.6 |
| Sex: Female, Male(Participants) | Mometasone Furoate Nasal Spray Day 1 | Placebo Day 1 | Mometasone Furoate Nasal Spray Day 8 | Placebo Day 8 | Total |
|---|---|---|---|---|---|
| Female | 45 | 46 | 40 | 44 | 175 |
| Male | 32 | 32 | 38 | 33 | 135 |
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