Trial Outcomes & Findings for This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED) (NCT NCT00491504)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

310 participants

Primary outcome timeframe

Baseline and 6 hours following initial dosing

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray Day 1 Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose	Placebo Day 1 Placebo: 2 sprays each nostril for 1 dose	Mometasone Furoate Nasal Spray Day 8 Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days	Placebo Day 8 Placebo: 2 sprays each nostril for 7 days
Overall Study STARTED	77	78	78	77
Overall Study COMPLETED	77	77	74	73
Overall Study NOT COMPLETED	0	1	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Day 1 Placebo: 2 sprays each nostril for 1 dose	Mometasone Furoate Nasal Spray Day 8 Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days	Placebo Day 8 Placebo: 2 sprays each nostril for 7 days
Overall Study Protocol Violation	0	3	2
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	0	1	2

Baseline Characteristics

This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate Nasal Spray Day 1 n=77 Participants Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose	Placebo Day 1 n=78 Participants Placebo: 2 sprays each nostril for 1 dose	Mometasone Furoate Nasal Spray Day 8 n=78 Participants Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days	Placebo Day 8 n=77 Participants Placebo: 2 sprays each nostril for 7 days	Total n=310 Participants Total of all reporting groups
Age, Continuous	38.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	36.3 years STANDARD_DEVIATION 10.1 • n=7 Participants	36.9 years STANDARD_DEVIATION 10.2 • n=5 Participants	38.9 years STANDARD_DEVIATION 11.2 • n=4 Participants	37.6 years STANDARD_DEVIATION 10.6 • n=21 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	46 Participants n=7 Participants	40 Participants n=5 Participants	44 Participants n=4 Participants	175 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	32 Participants n=7 Participants	38 Participants n=5 Participants	33 Participants n=4 Participants	135 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 6 hours following initial dosing

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray 200 mcg n=155 Participants All subjects who received 2 sprays each nostril (total 200 mcg) of Mometasone Furoate Nasal Spray (MFNS) on Day 1	Placebo n=155 Participants All subjects who received 2 sprays each nostril of placebo on Day 1
Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1	-2.01 score on a scale Standard Error 0.23	-1.86 score on a scale Standard Error 0.23

Adverse Events

Mometasone Furoate Nasal Spray Day 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Day 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Mometasone Furoate Nasal Spray Day 8

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Day 8

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mometasone Furoate Nasal Spray Day 1 n=77 participants at risk Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose	Placebo Day 1 n=78 participants at risk Placebo: 2 sprays each nostril for 1 dose	Mometasone Furoate Nasal Spray Day 8 n=78 participants at risk Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days	Placebo Day 8 n=77 participants at risk Placebo: 2 sprays each nostril for 7 days
Nervous system disorders Headache	1.3% 1/77 • Number of events 1	1.3% 1/78 • Number of events 1	7.7% 6/78 • Number of events 6	5.2% 4/77 • Number of events 4

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