Trial Outcomes & Findings for Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500) (NCT NCT00552110)

Last Updated: 2024-05-14

Results Overview

Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

707 participants

Primary outcome timeframe

15 days of treatment

Results posted on

2024-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Combination1 Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily	Combination3 MFNS with OXY 3 sprays once daily	Mometasone MFNS once daily	Oxymetazoline OXY twice daily	Placebo Placebo nasal spray
Overall Study STARTED	146	139	139	141	142
Overall Study COMPLETED	142	134	137	133	133
Overall Study NOT COMPLETED	4	5	2	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination1 Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily	Combination3 MFNS with OXY 3 sprays once daily	Mometasone MFNS once daily	Oxymetazoline OXY twice daily	Placebo Placebo nasal spray
Overall Study Serious or Life-Threatening AE	0	0	1	0	0
Overall Study Lack of Efficacy	1	0	0	1	4
Overall Study Withdrawal by Subject	0	2	0	3	2
Overall Study Lost to Follow-up	0	0	0	1	1
Overall Study Failed to Comply With Study Requirements	1	1	1	0	1
Overall Study Withdrawn per Sponsor	0	1	0	0	1
Overall Study Use of Prohibited Medication	1	1	0	0	0
Overall Study Delay of Study due to Relabeling	0	0	0	1	0
Overall Study Increased Blood Pressure at Visit 2	0	0	0	1	0
Overall Study Nonserious Adverse Event (AE)	1	0	0	1	0

Baseline Characteristics

Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination1 n=145 Participants Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily	Combination3 n=139 Participants MFNS with OXY 3 sprays once daily	Mometasone n=139 Participants MFNS once daily	Oxymetazoline n=140 Participants OXY twice daily	Placebo n=142 Participants Placebo nasal spray	Total n=705 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=93 Participants	12 Participants n=4 Participants	5 Participants n=27 Participants	5 Participants n=483 Participants	12 Participants n=36 Participants	42 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	135 Participants n=93 Participants	124 Participants n=4 Participants	132 Participants n=27 Participants	131 Participants n=483 Participants	127 Participants n=36 Participants	649 Participants n=10 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	3 Participants n=36 Participants	14 Participants n=10 Participants
Sex: Female, Male Female	93 Participants n=93 Participants	93 Participants n=4 Participants	101 Participants n=27 Participants	95 Participants n=483 Participants	89 Participants n=36 Participants	471 Participants n=10 Participants
Sex: Female, Male Male	52 Participants n=93 Participants	46 Participants n=4 Participants	38 Participants n=27 Participants	45 Participants n=483 Participants	53 Participants n=36 Participants	234 Participants n=10 Participants

PRIMARY outcome

Timeframe: 15 days of treatment

Population: Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug

Outcome measures

Outcome measures
Measure	Combination1 n=145 Participants Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily	Combination3 n=138 Participants MFNS with OXY 3 sprays once daily	Mometasone n=139 Participants MFNS once daily	Oxymetazoline n=139 Participants OXY twice daily	Placebo n=140 Participants Placebo nasal spray
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	-3.29 units on a scale Standard Error 0.209	-3.36 units on a scale Standard Error 0.216	-2.97 units on a scale Standard Error 0.213	-2.44 units on a scale Standard Error 0.215	-1.90 units on a scale Standard Error 0.209

PRIMARY outcome

Timeframe: from baseline to hour 4 on Day 1

Population: Intention to treat: all randomized subjects who had taken at least one dose of study drug

Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.

Outcome measures

Outcome measures
Measure	Combination1 n=144 Participants Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily	Combination3 n=138 Participants MFNS with OXY 3 sprays once daily	Mometasone n=139 Participants MFNS once daily	Oxymetazoline n=139 Participants OXY twice daily	Placebo n=140 Participants Placebo nasal spray
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	-0.80 units on a scale Standard Error 0.056	-0.92 units on a scale Standard Error 0.057	-0.63 units on a scale Standard Error 0.057	-1.06 units on a scale Standard Error 0.057	-0.57 units on a scale Standard Error 0.056

Adverse Events

Combination1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Combination3

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Mometasone

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Oxymetazoline

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination1 n=145 participants at risk Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily	Combination3 n=139 participants at risk MFNS with OXY 3 sprays once daily	Mometasone n=139 participants at risk MFNS once daily	Oxymetazoline n=140 participants at risk OXY twice daily	Placebo n=142 participants at risk Placebo nasal spray
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/145	0.00% 0/139	0.00% 0/139	0.00% 0/140	0.70% 1/142 • Number of events 1
Gastrointestinal disorders Oesophageal Haemorrhage	0.00% 0/145	0.00% 0/139	0.72% 1/139 • Number of events 1	0.00% 0/140	0.00% 0/142

Other adverse events

Other adverse events
Measure	Combination1 n=145 participants at risk Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily	Combination3 n=139 participants at risk MFNS with OXY 3 sprays once daily	Mometasone n=139 participants at risk MFNS once daily	Oxymetazoline n=140 participants at risk OXY twice daily	Placebo n=142 participants at risk Placebo nasal spray
Nervous system disorders Headache	4.8% 7/145 • Number of events 9	3.6% 5/139 • Number of events 5	7.2% 10/139 • Number of events 11	5.0% 7/140 • Number of events 8	5.6% 8/142 • Number of events 8

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: LTE60