A Phase 3 interventional study of Mometasone furoate nasal spray (MFNS) and Loratadine in Rhinitis, Allergic, 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
The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 704 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:
Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.
Drug: Mometasone furoate nasal spray (MFNS) · Drug: Loratadine
Daily administration of 200 µg of MFNS plus oral placebo tablet.
Drug: Mometasone furoate nasal spray (MFNS) · Drug: Placebo tablet
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Drug: Loratadine · Drug: Placebo nasal spray
Daily administration of placebo nasal spray plus oral placebo tablet.
Drug: Placebo nasal spray · Drug: Placebo tablet
Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.
Also known as: SCH 32088, MK-0887, NASONEX®
Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.
Also known as: Claritin®
Daily dose of placebo administered as a nasal spray for 15 days.
Daily dose of placebo administered as an oral tablet for 15 days.
Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)
Change From Baseline in Total Symptom Score (Assessed by Participant)
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)
Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Time frame: Baseline and study day 15
Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Time frame: Baseline and study day 15
Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Time frame: Baseline and study day 8
Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Time frame: Baseline and study day 8
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Time frame: Baseline and study day 15
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Time frame: Baseline and study day 8
Response to Therapy on Day 15 (Assessed by Physician)
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.
Time frame: Study day 15
Response to Therapy on Day 8 (Assessed by Physician)
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.
Time frame: Study day 8
| Milestone | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Started | 169 | 176 | 182 | 177 |
| Treated | 169 | 176 | 181 | 176 |
| Completed | 166 | 167 | 174 | 158 |
| Not completed | 3 | 9 | 8 | 19 |
| Withdrew: Adverse event | 2 | 4 | 4 | 8 |
| Withdrew: Treatment failure | 1 | 2 | 1 | 8 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 | 2 | 1 |
| Withdrew: Did not meet entry requirements | 0 | 2 | 1 | 1 |
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 7.9 ± 2.2 | 7.8 ± 2.2 | 7.9 ± 2.2 | 8.0 ± 2.1 |
| Change From Baseline Days 1-15 | -3.0 ± 2.6 | -2.7 ± 2.5 | -1.9 ± 2.2 | -1.4 ± 2.2 |
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 14.3 ± 4.1 | 14.2 ± 4.4 | 14.4 ± 4.5 | 14.6 ± 4.3 |
| Change From Baseline Days 1-15 | -5.4 ± 4.8 | -4.8 ± 4.7 | -3.8 ± 4.2 | -2.7 ± 4.2 |
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 8.7 ± 1.8 | 8.6 ± 1.8 | 8.6 ± 1.7 | 8.8 ± 1.8 |
| Change From Baseline Day 15 | -4.4 ± 3.1 | -4.2 ± 2.8 | -3.1 ± 2.8 | -2.8 ± 2.8 |
The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 15.9 ± 3.1 | 16.1 ± 3.4 | 15.9 ± 3.2 | 16.2 ± 3.5 |
| Change From Baseline Day 15 | -8.2 ± 5.3 | -8.0 ± 5.1 | -6.2 ± 5.1 | -5.4 ± 5.3 |
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 8.7 ± 1.8 | 8.6 ± 1.8 | 8.6 ± 1.7 | 8.8 ± 1.8 |
| Change From Baseline Day 8 | -3.7 ± 3.1 | -3.6 ± 2.7 | -2.6 ± 2.6 | -2.2 ± 2.5 |
The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 15.9 ± 3.1 | 16.1 ± 3.4 | 15.9 ± 3.2 | 16.2 ± 3.5 |
| Change From Baseline Day 8 | -7.0 ± 5.4 | -6.9 ± 4.9 | -5.2 ± 4.6 | -4.6 ± 4.7 |
The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 2.3 ± 0.5 | 2.3 ± 0.5 | 2.3 ± 0.5 | 2.3 ± 0.5 |
| Change From Baseline Day 15 | -0.9 ± 0.7 | -0.9 ± 0.7 | -0.6 ± 0.8 | -0.6 ± 0.7 |
The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Baseline | 2.3 ± 0.5 | 2.3 ± 0.5 | 2.3 ± 0.5 | 2.3 ± 0.5 |
| Change From Baseline Day 8 | -0.8 ± 0.8 | -0.7 ± 0.7 | -0.5 ± 0.7 | -0.5 ± 0.7 |
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Response to Therapy on Day 15 (Assessed by Physician) | 2.8 ± 1.0 | 3.0 ± 1.0 | 3.4 ± 1.1 | 3.4 ± 1.1 |
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.
| Score on a scale | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo |
|---|---|---|---|---|
| Response to Therapy on Day 8 (Assessed by Physician) | 3.0 ± 1.1 | 3.1 ± 1.0 | 3.4 ± 0.9 | 3.6 ± 1.0 |
Collected over Up to approximately 45 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MFNS Pus Loratadine | 0/169 (0%) | 0/169 (0%) | 22/169 (13%) |
| MFNS 200 | 0/176 (0%) | 0/176 (0%) | 22/176 (12.5%) |
| Loratadine | 0/181 (0%) | 0/181 (0%) | 33/181 (18.2%) |
| Placebo | 0/176 (0%) | 0/176 (0%) | 21/176 (11.9%) |
| Event | MFNS Pus Loratadine | MFNS 200 | Loratadine | Placebo |
|---|---|---|---|---|
| HEADACHENervous system disorders | 22/169 | 22/176 | 33/181 | 21/176 |
Includes all randomized participants who received ≥1 dose of study treatment.
| Age, Continuous(Years) | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 25.6 ± 13.1 | 25.6 ± 13.2 | 25.2 ± 12.6 | 25.6 ± 13.3 | 25.5 ± 13.0 |
| Sex: Female, Male(Participants) | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 85 | 89 | 91 | 85 | 350 |
| Male | 84 | 87 | 90 | 91 | 352 |
| Ethnicity (NIH/OMB)(Participants) | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 7 | 9 | 7 | 7 | 30 |
| Not Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 162 | 167 | 174 | 169 | 672 |
| Race (NIH/OMB)(Participants) | MFNS 200 μg + Loratadine 10 mg | MFNS 200 μg | Loratadine 10 mg | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 3 | 2 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 12 | 7 | 12 | 41 |
| White | 150 | 154 | 164 | 154 | 622 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 10 | 7 | 8 | 32 |
No study locations are listed for this record.
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Organon and Co