Trial Outcomes & Findings for Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED) (NCT NCT00453063)
NCT ID: NCT00453063
Last Updated: 2022-02-09
Results Overview
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.
COMPLETED
PHASE3
426 participants
Baseline and 15 days
2022-02-09
Participant Flow
Participant milestones
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
Two sprays in each nostril once daily
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
215
|
|
Overall Study
COMPLETED
|
208
|
212
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
Two sprays in each nostril once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=211 Participants
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
n=215 Participants
Two sprays in each nostril once daily
|
Total
n=426 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
188 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 15 daysPopulation: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
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.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=209 Participants
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
n=213 Participants
Two sprays in each nostril once daily
|
|---|---|---|
|
Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
Baseline TNSS
|
9.83 units on a scale
Standard Deviation 1.56
|
9.69 units on a scale
Standard Deviation 1.56
|
|
Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
Change from Baseline in TNSS
|
-2.36 units on a scale
Standard Deviation 2.07
|
-1.71 units on a scale
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: Baseline and 15 daysPopulation: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
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.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=209 Participants
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
n=213 Participants
Two sprays in each nostril once daily
|
|---|---|---|
|
Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
Baseline TOSS
|
7.07 units on a scale
Standard Deviation 1.54
|
7.01 units on a scale
Standard Deviation 1.54
|
|
Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
Change from Baseline in TOSS
|
-1.52 units on a scale
Standard Deviation 1.59
|
-1.36 units on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline and 15 daysPopulation: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
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.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=209 Participants
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
n=213 Participants
Two sprays in each nostril once daily
|
|---|---|---|
|
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Baseline Nasal Congestion Score
|
2.66 units on a scale
Standard Deviation 0.40
|
2.64 units on a scale
Standard Deviation 0.40
|
|
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Change from Baseline in Nasal Congestion Score
|
-0.54 units on a scale
Standard Deviation 0.54
|
-0.39 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline and 15 daysPopulation: The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group.
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.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=189 Participants
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
n=182 Participants
Two sprays in each nostril once daily
|
|---|---|---|
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
Baseline RQLQ Total Score
|
4.19 units on a scale
Standard Deviation 0.97
|
4.42 units on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
Change from Baseline in RQLQ Total Score
|
-1.63 units on a scale
Standard Deviation 1.37
|
-1.36 units on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Baseline and 15 daysPopulation: All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.
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.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=209 Participants
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
|
Placebo
n=213 Participants
Two sprays in each nostril once daily
|
|---|---|---|
|
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Baseline PNIF
|
89.11 liters/minute
Standard Deviation 37.2
|
88.85 liters/minute
Standard Deviation 37.2
|
|
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Change from Baseline in PNIF
|
10.15 liters/minute
Standard Deviation 21.1
|
8.24 liters/minute
Standard Deviation 21.1
|
Adverse Events
Mometasone Furoate Nasal Spray (MFNS)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
- Publication restrictions are in place
Restriction type: OTHER