Trial Outcomes & Findings for Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583) (NCT NCT00728416)

Results Overview

Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

333 participants

Primary outcome timeframe

15 days of treatment

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray Mometasone furoate nasal spray 200 mcg QD (once per day)	Placebo Nasal Spray Matching placebo nasal spray
Overall Study STARTED	168	165
Overall Study COMPLETED	166	163
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Mometasone Furoate Nasal Spray Mometasone furoate nasal spray 200 mcg QD (once per day)	Placebo Nasal Spray Matching placebo nasal spray
Overall Study Adverse Event	1	1
Overall Study Treatment Failure	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate Nasal Spray n=168 Participants Mometasone furoate nasal spray 200 mcg QD (once per day)	Placebo Nasal Spray n=165 Participants Matching placebo nasal spray	Total n=333 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	148 Participants n=93 Participants	146 Participants n=4 Participants	294 Participants n=27 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Sex: Female, Male Female	109 Participants n=93 Participants	103 Participants n=4 Participants	212 Participants n=27 Participants
Sex: Female, Male Male	59 Participants n=93 Participants	62 Participants n=4 Participants	121 Participants n=27 Participants

PRIMARY outcome

Timeframe: 15 days of treatment

Population: 1 participant without baseline value excluded from the Placebo Nasal Spray population.

Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray n=168 Participants Mometasone furoate nasal spray 200 mcg QD (once per day)	Placebo Nasal Spray n=164 Participants Matching placebo nasal spray
Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days	-0.71 Units on a scale 95% Confidence Interval 0.55 • Interval -0.81 to -0.61	-0.40 Units on a scale 95% Confidence Interval 0.55 • Interval -0.5 to -0.3

SECONDARY outcome

Timeframe: 15 days of treatment

Population: 1 participant without baseline value excluded from the Placebo Nasal Spray population.

Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray n=168 Participants Mometasone furoate nasal spray 200 mcg QD (once per day)	Placebo Nasal Spray n=164 Participants Matching placebo nasal spray
Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days	-3.00 Units on a scale 95% Confidence Interval 2.03 • Interval -3.38 to -2.62	-1.73 Units on a scale 95% Confidence Interval 2.03 • Interval -2.11 to -1.34

Adverse Events

Mometasone Furoate Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Nasal Spray

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
Publication restrictions are in place

Restriction type: GT60