Trial Outcomes & Findings for Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161) (NCT NCT03879772)

NCT ID: NCT03879772

Last Updated: 2022-02-09

Results Overview

The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

679 participants

Primary outcome timeframe

Baseline (Day 1) and Day 8

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure
MFNS 25 mcg QD
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Study
STARTED
137
135
133
138
136
Overall Study
COMPLETED
133
132
123
130
128
Overall Study
NOT COMPLETED
4
3
10
8
8

Reasons for withdrawal

Reasons for withdrawal
Measure
MFNS 25 mcg QD
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Study
Adverse Event
2
2
3
4
3
Overall Study
Treatment Failure
1
0
0
2
1
Overall Study
Lost to Follow-up
0
0
0
0
1
Overall Study
Withdrawal by Subject
0
1
3
1
1
Overall Study
Protocol Violation
0
0
3
1
2
Overall Study
Did Not Meet Entry Requirements
1
0
1
0
0

Baseline Characteristics

Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MFNS 25 mcg QD
n=137 Participants
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=135 Participants
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=133 Participants
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=138 Participants
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=136 Participants
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Total
n=679 Participants
Total of all reporting groups
Age, Continuous
8.8 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
8.7 Years
STANDARD_DEVIATION 1.6 • n=7 Participants
8.8 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
8.7 Years
STANDARD_DEVIATION 1.6 • n=4 Participants
8.8 Years
STANDARD_DEVIATION 1.6 • n=21 Participants
8.8 Years
STANDARD_DEVIATION 1.6 • n=8 Participants
Sex: Female, Male
Female
52 Participants
n=5 Participants
51 Participants
n=7 Participants
54 Participants
n=5 Participants
51 Participants
n=4 Participants
52 Participants
n=21 Participants
260 Participants
n=8 Participants
Sex: Female, Male
Male
85 Participants
n=5 Participants
84 Participants
n=7 Participants
79 Participants
n=5 Participants
87 Participants
n=4 Participants
84 Participants
n=21 Participants
419 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
11 Participants
n=5 Participants
11 Participants
n=7 Participants
8 Participants
n=5 Participants
8 Participants
n=4 Participants
11 Participants
n=21 Participants
49 Participants
n=8 Participants
Race (NIH/OMB)
White
114 Participants
n=5 Participants
111 Participants
n=7 Participants
112 Participants
n=5 Participants
119 Participants
n=4 Participants
113 Participants
n=21 Participants
569 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
n=5 Participants
13 Participants
n=7 Participants
13 Participants
n=5 Participants
11 Participants
n=4 Participants
12 Participants
n=21 Participants
61 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 8

Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 8 visit data for TNSS.

The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

Outcome measures

Outcome measures
Measure
MFNS 25 mcg QD
n=137 Participants
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=135 Participants
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=132 Participants
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=136 Participants
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=134 Participants
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
Baseline
7.8 Scores on a scale
Standard Deviation 1.7
8.1 Scores on a scale
Standard Deviation 1.7
7.9 Scores on a scale
Standard Deviation 1.6
8.0 Scores on a scale
Standard Deviation 1.7
8.0 Scores on a scale
Standard Deviation 1.5
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
Change From Baseline Day 8
-2.8 Scores on a scale
Standard Deviation 2.6
-2.8 Scores on a scale
Standard Deviation 2.6
-2.8 Scores on a scale
Standard Deviation 2.5
-2.8 Scores on a scale
Standard Deviation 2.4
-1.9 Scores on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 4

Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 4 visit data for TNSS.

The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

Outcome measures

Outcome measures
Measure
MFNS 25 mcg QD
n=137 Participants
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=135 Participants
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=132 Participants
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=136 Participants
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=134 Participants
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
Baseline
7.8 Scores on a scale
Standard Deviation 1.7
8.1 Scores on a scale
Standard Deviation 1.7
7.9 Scores on a scale
Standard Deviation 1.6
8.0 Scores on a scale
Standard Deviation 1.7
8.0 Scores on a scale
Standard Deviation 1.5
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
Change From Baseline Day 4
-2.2 Scores on a scale
Standard Deviation 2.4
-2.0 Scores on a scale
Standard Deviation 2.1
-2.0 Scores on a scale
Standard Deviation 2.5
-2.4 Scores on a scale
Standard Deviation 2.3
-1.3 Scores on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 15

Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 15 visit data for TNSS.

The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

Outcome measures

Outcome measures
Measure
MFNS 25 mcg QD
n=137 Participants
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=135 Participants
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=132 Participants
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=136 Participants
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=134 Participants
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
Baseline
7.8 Scores on a scale
Standard Deviation 1.7
8.1 Scores on a scale
Standard Deviation 1.7
7.9 Scores on a scale
Standard Deviation 1.6
8.0 Scores on a scale
Standard Deviation 1.7
8.0 Scores on a scale
Standard Deviation 1.5
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
Change From Baseline Day 15
-2.9 Scores on a scale
Standard Deviation 2.7
-3.0 Scores on a scale
Standard Deviation 2.8
-3.1 Scores on a scale
Standard Deviation 2.7
-3.5 Scores on a scale
Standard Deviation 2.8
-2.4 Scores on a scale
Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 29

Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 29 visit data for TNSS.

The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

Outcome measures

Outcome measures
Measure
MFNS 25 mcg QD
n=137 Participants
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=135 Participants
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=132 Participants
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=136 Participants
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=134 Participants
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
Baseline
7.8 Scores on a scale
Standard Deviation 1.7
8.1 Scores on a scale
Standard Deviation 1.7
7.9 Scores on a scale
Standard Deviation 1.6
8.0 Scores on a scale
Standard Deviation 1.7
8.0 Scores on a scale
Standard Deviation 1.5
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
Change From Baseline Day 29
-3.1 Scores on a scale
Standard Deviation 2.9
-3.7 Scores on a scale
Standard Deviation 2.8
-3.8 Scores on a scale
Standard Deviation 2.6
-3.7 Scores on a scale
Standard Deviation 3.0
-2.5 Scores on a scale
Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline and Days 1 through 15 (average over 15 days)

Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.

Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.

Outcome measures

Outcome measures
Measure
MFNS 25 mcg QD
n=137 Participants
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=134 Participants
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=133 Participants
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=137 Participants
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=134 Participants
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant
Baseline
6.3 Scores on a scale
Standard Deviation 2.3
6.9 Scores on a scale
Standard Deviation 2.4
6.9 Scores on a scale
Standard Deviation 2.4
6.6 Scores on a scale
Standard Deviation 2.4
6.8 Scores on a scale
Standard Deviation 2.5
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant
Change From Baseline Days 1 to 15
-1.5 Scores on a scale
Standard Deviation 2.1
-1.9 Scores on a scale
Standard Deviation 2.0
-1.8 Scores on a scale
Standard Deviation 2.1
-1.9 Scores on a scale
Standard Deviation 2.1
-1.2 Scores on a scale
Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline and Days 16 through 29 (average over 15 days)

Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.

Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.

Outcome measures

Outcome measures
Measure
MFNS 25 mcg QD
n=137 Participants
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=134 Participants
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=133 Participants
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=137 Participants
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=134 Participants
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant
Baseline
6.3 Scores on a scale
Standard Deviation 2.3
6.9 Scores on a scale
Standard Deviation 2.4
6.9 Scores on a scale
Standard Deviation 2.4
6.6 Scores on a scale
Standard Deviation 2.4
6.8 Scores on a scale
Standard Deviation 2.5
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant
Change From Baseline Days 16 to 29
-2.1 Scores on a scale
Standard Deviation 2.6
-2.8 Scores on a scale
Standard Deviation 2.8
-2.7 Scores on a scale
Standard Deviation 2.7
-2.6 Scores on a scale
Standard Deviation 2.8
-1.7 Scores on a scale
Standard Deviation 2.7

Adverse Events

MFNS 25 mcg QD

Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths

MFNS 100 mcg QD

Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths

MFNS 200 mcg QD

Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths

BDP 84 mcg BID

Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
MFNS 25 mcg QD
n=137 participants at risk
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=135 participants at risk
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=133 participants at risk
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=138 participants at risk
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=136 participants at risk
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Ear and labyrinth disorders
Ear pain
0.00%
0/137
0.00%
0/135
0.75%
1/133 • Number of events 1
0.00%
0/138
0.00%
0/136
Gastrointestinal disorders
Vomiting
0.00%
0/137
0.00%
0/135
0.75%
1/133 • Number of events 1
0.00%
0/138
0.00%
0/136
General disorders
Pyrexia
0.00%
0/137
0.00%
0/135
0.75%
1/133 • Number of events 1
0.00%
0/138
0.00%
0/136
Infections and infestations
Sinusitis
0.00%
0/137
0.00%
0/135
0.75%
1/133 • Number of events 1
0.00%
0/138
0.00%
0/136
Musculoskeletal and connective tissue disorders
Pathological fracture
0.73%
1/137 • Number of events 1
0.00%
0/135
0.00%
0/133
0.00%
0/138
0.00%
0/136

Other adverse events

Other adverse events
Measure
MFNS 25 mcg QD
n=137 participants at risk
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
n=135 participants at risk
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
n=133 participants at risk
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
n=138 participants at risk
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
n=136 participants at risk
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Gastrointestinal disorders
Abdominal pain upper
3.6%
5/137 • Number of events 5
3.0%
4/135 • Number of events 4
2.3%
3/133 • Number of events 5
5.8%
8/138 • Number of events 8
1.5%
2/136 • Number of events 3
Gastrointestinal disorders
Nausea
5.1%
7/137 • Number of events 13
0.74%
1/135 • Number of events 1
1.5%
2/133 • Number of events 2
2.2%
3/138 • Number of events 3
1.5%
2/136 • Number of events 2
Gastrointestinal disorders
Vomiting
2.2%
3/137 • Number of events 3
5.2%
7/135 • Number of events 7
2.3%
3/133 • Number of events 3
3.6%
5/138 • Number of events 6
2.9%
4/136 • Number of events 4
General disorders
Pyrexia
5.1%
7/137 • Number of events 7
5.9%
8/135 • Number of events 8
8.3%
11/133 • Number of events 13
7.2%
10/138 • Number of events 11
8.1%
11/136 • Number of events 11
Nervous system disorders
Headache
18.2%
25/137 • Number of events 44
20.0%
27/135 • Number of events 51
16.5%
22/133 • Number of events 28
26.1%
36/138 • Number of events 69
17.6%
24/136 • Number of events 34
Respiratory, thoracic and mediastinal disorders
Asthma
8.8%
12/137 • Number of events 23
7.4%
10/135 • Number of events 28
7.5%
10/133 • Number of events 15
5.8%
8/138 • Number of events 14
12.5%
17/136 • Number of events 26
Respiratory, thoracic and mediastinal disorders
Cough
6.6%
9/137 • Number of events 11
5.2%
7/135 • Number of events 11
13.5%
18/133 • Number of events 24
8.0%
11/138 • Number of events 18
7.4%
10/136 • Number of events 17
Respiratory, thoracic and mediastinal disorders
Epistaxis
10.2%
14/137 • Number of events 19
8.9%
12/135 • Number of events 20
4.5%
6/133 • Number of events 8
4.3%
6/138 • Number of events 10
7.4%
10/136 • Number of events 12
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
7.3%
10/137 • Number of events 11
4.4%
6/135 • Number of events 7
8.3%
11/133 • Number of events 14
7.2%
10/138 • Number of events 18
8.8%
12/136 • Number of events 15
Respiratory, thoracic and mediastinal disorders
Sneezing
5.1%
7/137 • Number of events 11
3.0%
4/135 • Number of events 4
0.00%
0/133
1.4%
2/138 • Number of events 4
5.1%
7/136 • Number of events 8

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Results disclosure agreements

  • Principal investigator is a sponsor employee The Principal Investigator agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of the Sponsor. The Principal Investigator further agrees to provide thirty (30) days prior to submission for publication or presentation to the Sponsor to review copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the Protocol study.
  • Publication restrictions are in place

Restriction type: OTHER