Trial Outcomes & Findings for Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106)(COMPLETED) (NCT NCT00468312)

Results Overview

TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

429 participants

Primary outcome timeframe

Screening through 15 days daily

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray (MFNS) MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Placebo Two sprays in each nostril once daily
Overall Study STARTED	220	209
Overall Study COMPLETED	216	204
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Mometasone Furoate Nasal Spray (MFNS) MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Placebo Two sprays in each nostril once daily
Overall Study Adverse Event	2	1
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study Protocol Violation	2	1
Overall Study Did not meet protocol eligibility	0	1

Baseline Characteristics

Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate Nasal Spray (MFNS) n=220 Participants MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Placebo n=209 Participants Two sprays in each nostril once daily	Total n=429 Participants Total of all reporting groups
Age, Customized 6 - <12 years	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Age, Customized 12 - <18 years	31 participants n=5 Participants	24 participants n=7 Participants	55 participants n=5 Participants
Age, Customized 18 - <65 years	184 participants n=5 Participants	181 participants n=7 Participants	365 participants n=5 Participants
Age, Customized >=65 years	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Sex: Female, Male Female	132 Participants n=5 Participants	125 Participants n=7 Participants	257 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	84 Participants n=7 Participants	172 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening through 15 days daily

Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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, and 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

Outcome measures
Measure	Mometasone Furoate Nasal Spray (MFNS) n=220 Participants MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Placebo n=208 Participants Two sprays in each nostril once daily
Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 Baseline TNSS	9.31 Score on a scale Standard Deviation 1.60	9.31 Score on a scale Standard Deviation 1.60
Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 Change from Baseline in TNSS	-2.54 Score on a scale Standard Deviation 1.99	-1.66 Score on a scale Standard Deviation 1.99

PRIMARY outcome

Timeframe: Screening through 15 days daily

Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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 the scale is 9.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray (MFNS) n=220 Participants MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Placebo n=208 Participants Two sprays in each nostril once daily
Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 Baseline TOSS	6.78 Score on a scale Standard Deviation 1.46	6.74 Score on a scale Standard Deviation 1.46
Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 Change from Baseline in TOSS	-1.71 Score on a scale Standard Deviation 1.60	-1.37 Score on a scale Standard Deviation 1.60

SECONDARY outcome

Timeframe: Screening through 15 days daily

Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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 measures 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

Outcome measures
Measure	Mometasone Furoate Nasal Spray (MFNS) n=220 Participants MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Placebo n=208 Participants Two sprays in each nostril once daily
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 change from Baseline in Nasal Congestion Score	-0.59 Score on a scale Standard Deviation 0.53	-0.39 Score on a scale Standard Deviation 0.53
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 Baseline Nasal Congestion Score	2.60 Score on a scale Standard Deviation 0.38	2.62 Score on a scale Standard Deviation 0.38

SECONDARY outcome

Timeframe: Baseline and 15 days

Population: The RQLQ tool is only validated in participants greater than or equal to 18 years of age. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.

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

Outcome measures
Measure	Mometasone Furoate Nasal Spray (MFNS) n=189 Participants MFNS 200 mcg (two sprays in each nostril) once daily 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	4.27 Score on a scale Standard Deviation 1.01	4.28 Score on a scale Standard Deviation 1.01
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	-1.81 Score on a scale Standard Deviation 1.36	-1.08 Score on a scale Standard Deviation 1.36

SECONDARY outcome

Timeframe: Screening through 15 days daily

Population: All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants 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

Outcome measures
Measure	Mometasone Furoate Nasal Spray (MFNS) n=220 Participants MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Placebo n=208 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	93.12 liters/minute Standard Deviation 41.3	91.96 liters/minute Standard Deviation 41.3
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 Change from Baseline in PNIF	16.55 liters/minute Standard Deviation 36.9	12.59 liters/minute Standard Deviation 36.9

Adverse Events

Mometasone Furoate Nasal Spray (MFNS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's represnetatives will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
Publication restrictions are in place

Restriction type: OTHER