Trial Outcomes & Findings for Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED) (NCT NCT00635882)
NCT ID: NCT00635882
Last Updated: 2024-05-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Baseline to Day 14
Results posted on
2024-05-14
Participant Flow
Participant milestones
| Measure |
MF/F MDI 100/10 mcg
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
MF MDI 200 mcg BID for 14 days
|
Placebo
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
12
|
15
|
16
|
13
|
|
Overall Study
COMPLETED
|
19
|
17
|
12
|
15
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MF/F MDI 100/10 mcg
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
MF MDI 200 mcg BID for 14 days
|
Placebo
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MF/F MDI 100/10 mcg
n=20 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=17 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=15 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=16 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18 to <65 years
|
20 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
15 participants
n=4 Participants
|
16 participants
n=21 Participants
|
11 participants
n=8 Participants
|
87 participants
n=8 Participants
|
|
Age, Customized
> or = to 65 years
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
6 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 14Population: All Randomized Participants
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=19 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=16 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=14 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=15 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)
|
-35.3 percentage of eNO
Standard Deviation 40.3
|
-45.4 percentage of eNO
Standard Deviation 40.3
|
-61.4 percentage of eNO
Standard Deviation 40.3
|
-51.3 percentage of eNO
Standard Deviation 40.3
|
-46.1 percentage of eNO
Standard Deviation 40.3
|
0.1 percentage of eNO
Standard Deviation 40.3
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: All Randomized Participants
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=19 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=16 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=14 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=15 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline to Day 7 in eNO Ppb
|
-37.9 percentage of eNO
Standard Deviation 36.3
|
-39.7 percentage of eNO
Standard Deviation 36.3
|
-45.6 percentage of eNO
Standard Deviation 36.3
|
-46.0 percentage of eNO
Standard Deviation 36.3
|
-37.2 percentage of eNO
Standard Deviation 36.3
|
4.8 percentage of eNO
Standard Deviation 36.3
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: All randomized participants
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=15 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=13 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=7 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=12 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=11 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=10 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)
|
21.1 percentage of Sputum Eosinophil Count
Standard Deviation 127.6
|
-35.5 percentage of Sputum Eosinophil Count
Standard Deviation 127.6
|
-75.4 percentage of Sputum Eosinophil Count
Standard Deviation 127.6
|
-55.3 percentage of Sputum Eosinophil Count
Standard Deviation 127.6
|
-33.7 percentage of Sputum Eosinophil Count
Standard Deviation 127.6
|
71.7 percentage of Sputum Eosinophil Count
Standard Deviation 127.6
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: All randomized participants
Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=12 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=9 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=6 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=8 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=9 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=9 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Day 15 of Mannitol Challenge
Baseline
|
102.2 milligrams
Standard Deviation 106.7
|
48.6 milligrams
Standard Deviation 106.7
|
67.9 milligrams
Standard Deviation 106.7
|
137.6 milligrams
Standard Deviation 106.7
|
126.0 milligrams
Standard Deviation 106.7
|
159.4 milligrams
Standard Deviation 106.7
|
|
Mean Change From Baseline to Day 15 of Mannitol Challenge
Mean Change from Baseline to Day 15
|
176.6 milligrams
Standard Deviation 264
|
153.8 milligrams
Standard Deviation 264
|
162.9 milligrams
Standard Deviation 264
|
159.4 milligrams
Standard Deviation 264
|
146.2 milligrams
Standard Deviation 264
|
-63.7 milligrams
Standard Deviation 264
|
SECONDARY outcome
Timeframe: Baseline and Days 2-15Population: All randomized participants
Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=20 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=17 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=15 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=16 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Change From Baseline in AM Total Asthma Symptom Score at Days 2-15
Baseline
|
1.6 units on a scale
Standard Deviation 1.66
|
1.2 units on a scale
Standard Deviation 1.66
|
2.2 units on a scale
Standard Deviation 1.66
|
1.5 units on a scale
Standard Deviation 1.66
|
1.1 units on a scale
Standard Deviation 1.66
|
1.4 units on a scale
Standard Deviation 1.66
|
|
Change From Baseline in AM Total Asthma Symptom Score at Days 2-15
Mean Change from Baseline to Days 2-15
|
-0.7 units on a scale
Standard Deviation 1.28
|
-0.7 units on a scale
Standard Deviation 1.28
|
-1.5 units on a scale
Standard Deviation 1.28
|
-1.2 units on a scale
Standard Deviation 1.28
|
-0.5 units on a scale
Standard Deviation 1.28
|
-0.2 units on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline and Days 1-15Population: All randomized participants
Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=20 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=17 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=15 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=15 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PM Total Asthma Symptom Score at Days 1-15
Baseline
|
1.7 units on a scale
Standard Deviation 1.62
|
1.1 units on a scale
Standard Deviation 1.62
|
2.1 units on a scale
Standard Deviation 1.62
|
1.6 units on a scale
Standard Deviation 1.62
|
1.6 units on a scale
Standard Deviation 1.62
|
1.7 units on a scale
Standard Deviation 1.62
|
|
Change From Baseline in PM Total Asthma Symptom Score at Days 1-15
Mean Change from Baseline to Days 1-15
|
-0.4 units on a scale
Standard Deviation 1.24
|
-0.6 units on a scale
Standard Deviation 1.24
|
-1.4 units on a scale
Standard Deviation 1.24
|
-1.1 units on a scale
Standard Deviation 1.24
|
-0.7 units on a scale
Standard Deviation 1.24
|
-0.3 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline and Days 2-15Population: All randomized participants
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=20 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=17 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=15 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=16 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15
Baseline
|
452.6 liters/minute
Standard Deviation 112.1
|
421.2 liters/minute
Standard Deviation 112.1
|
468.7 liters/minute
Standard Deviation 112.1
|
466.3 liters/minute
Standard Deviation 112.1
|
473.3 liters/minute
Standard Deviation 112.1
|
413.2 liters/minute
Standard Deviation 112.1
|
|
Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15
Mean Change from Baseline to Days 2-15
|
48.1 liters/minute
Standard Deviation 47.0
|
46.9 liters/minute
Standard Deviation 47.0
|
69.8 liters/minute
Standard Deviation 47.0
|
30.3 liters/minute
Standard Deviation 47.0
|
30.8 liters/minute
Standard Deviation 47.0
|
-9.0 liters/minute
Standard Deviation 47.0
|
SECONDARY outcome
Timeframe: Baseline and Days 1-15Population: All randomized participants
Outcome measures
| Measure |
MF/F MDI 100/10 mcg
n=20 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=17 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=15 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=15 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PM PEF at Days 1-15
Baseline
|
462.0 liters/minute
Standard Deviation 114.6
|
437.2 liters/minute
Standard Deviation 114.6
|
486.7 liters/minute
Standard Deviation 114.6
|
484.4 liters/minute
Standard Deviation 114.6
|
472.5 liters/minute
Standard Deviation 114.6
|
422.7 liters/minute
Standard Deviation 114.6
|
|
Change From Baseline in PM PEF at Days 1-15
Mean Change from Baseline to Days 1-15
|
47.7 liters/minute
Standard Deviation 42.3
|
34.5 liters/minute
Standard Deviation 42.3
|
66.8 liters/minute
Standard Deviation 42.3
|
20.2 liters/minute
Standard Deviation 42.3
|
28.3 liters/minute
Standard Deviation 42.3
|
4.5 liters/minute
Standard Deviation 42.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
MF/F MDI 100/10 mcg
n=19 Participants
Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
|
MF/F MDI 200/10 mcg
n=16 Participants
MF/F MDI 200/10 mcg BID for 14 days
|
MF/F MDI 400/10 mcg
n=12 Participants
MF/F MDI 400/10 mcg BID for 14 days
|
MF DPI 200 mcg
n=14 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
|
MF MDI 200 mcg
n=15 Participants
MF MDI 200 mcg BID for 14 days
|
Placebo
n=13 Participants
Placebo MDI BID for 14 days
|
|---|---|---|---|---|---|---|
|
Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)
|
54.8 ppb
Standard Deviation 40.8
|
70.0 ppb
Standard Deviation 40.8
|
77.1 ppb
Standard Deviation 40.8
|
102.6 ppb
Standard Deviation 40.8
|
66.2 ppb
Standard Deviation 40.8
|
79.6 ppb
Standard Deviation 40.8
|
Adverse Events
MF/F MDI 100/10 MCG BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MF/F MDI 200/10 MCG BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MF/F MDI 400/10 MCG BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MF DPI 200 MCG BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MF MDI 200 MCG BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PLACEBO
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MF/F MDI 100/10 MCG BID
n=20 participants at risk
|
MF/F MDI 200/10 MCG BID
n=17 participants at risk
|
MF/F MDI 400/10 MCG BID
n=12 participants at risk
|
MF DPI 200 MCG BID
n=15 participants at risk
|
MF MDI 200 MCG BID
n=16 participants at risk
|
PLACEBO
n=13 participants at risk
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/13
|
|
General disorders
PYREXIA
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
0.00%
0/12
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/13
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/20
|
0.00%
0/17
|
8.3%
1/12 • Number of events 1
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/13
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
6.7%
1/15 • Number of events 1
|
0.00%
0/16
|
0.00%
0/13
|
|
Injury, poisoning and procedural complications
SPINAL CORD INJURY
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
6.7%
1/15 • Number of events 1
|
0.00%
0/16
|
0.00%
0/13
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
12.5%
2/16 • Number of events 3
|
0.00%
0/13
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/20
|
11.8%
2/17 • Number of events 3
|
0.00%
0/12
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
0.00%
0/15
|
0.00%
0/16
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
6.7%
1/15 • Number of events 1
|
0.00%
0/16
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.0%
1/20 • Number of events 1
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.0%
1/20 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
0.00%
0/12
|
0.00%
0/15
|
12.5%
2/16 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/20
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/20
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/15
|
6.2%
1/16 • Number of events 1
|
0.00%
0/13
|
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 investigator agrees not to publish/present any interim results without prior sponsor written consent. The investigator agrees to provide to the sponsor, 45 days prior to submission, review copies for publication that report any study results. The sponsor has the right to review and comment. If the parties disagree, investigator agrees to meet with the sponsor, prior to submission for publication, to discuss and resolve any such issues/disagreement.
- Publication restrictions are in place
Restriction type: OTHER