Trial Outcomes & Findings for Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) (NCT NCT00381485)
NCT ID: NCT00381485
Last Updated: 2024-05-20
Results Overview
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
834 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2024-05-20
Participant Flow
834 participants enrolled in the open-label Run-In Period, of which 728 participants were randomized into 1 of 3 arms. Of 728 randomized participants, 643 participants overall completed the Treatment Period, while 85 participants overall discontinued investigational treatment early. All randomized participants received ≥1 dose of study medication.
Participant milestones
| Measure |
Open-Label MF MDI 400 mcg BID
Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
|
MF/F MDI 400/10 mcg BID
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
|---|---|---|---|---|
|
Open-Label Run-In Period
STARTED
|
834
|
0
|
0
|
0
|
|
Open-Label Run-In Period
COMPLETED
|
728
|
0
|
0
|
0
|
|
Open-Label Run-In Period
NOT COMPLETED
|
106
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
STARTED
|
0
|
255
|
233
|
240
|
|
Double-Blind Treatment Period
COMPLETED
|
0
|
228
|
208
|
207
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
0
|
27
|
25
|
33
|
Reasons for withdrawal
| Measure |
Open-Label MF MDI 400 mcg BID
Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
|
MF/F MDI 400/10 mcg BID
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
|---|---|---|---|---|
|
Open-Label Run-In Period
Adverse Event
|
9
|
0
|
0
|
0
|
|
Open-Label Run-In Period
Did not meet protocol eligibility
|
76
|
0
|
0
|
0
|
|
Open-Label Run-In Period
Withdrawal by Subject-reasons related
|
16
|
0
|
0
|
0
|
|
Open-Label Run-In Period
Withdrawal by Subject-reasons unrelated
|
1
|
0
|
0
|
0
|
|
Open-Label Run-In Period
Lost to Follow-up
|
3
|
0
|
0
|
0
|
|
Open-Label Run-In Period
Treatment failure
|
1
|
0
|
0
|
0
|
|
Double-Blind Treatment Period
Adverse Event
|
0
|
2
|
2
|
5
|
|
Double-Blind Treatment Period
Lack of Efficacy
|
0
|
8
|
11
|
13
|
|
Double-Blind Treatment Period
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Double-Blind Treatment Period
Noncompliance with protocol
|
0
|
9
|
3
|
3
|
|
Double-Blind Treatment Period
Did not meet protocol eligibility
|
0
|
5
|
7
|
5
|
|
Double-Blind Treatment Period
Withdrawal by Subject-reasons unrelated
|
0
|
2
|
1
|
4
|
|
Double-Blind Treatment Period
Withdrawal by Subject-reasons related
|
0
|
0
|
0
|
1
|
|
Double-Blind Treatment Period
Administrative
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MF/F MDI 400/10 mcg BID
n=255 Participants
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
n=233 Participants
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
n=240 Participants
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
Total
n=728 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
200 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
578 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
409 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
319 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=231 Participants
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
n=204 Participants
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
n=211 Participants
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
|---|---|---|---|
|
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
|
4.19 Liter x hour
Standard Deviation 3.63
|
3.59 Liter x hour
Standard Deviation 3.63
|
2.04 Liter x hour
Standard Deviation 3.63
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).
ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The ACQ Total score was the mean of the individual seven questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=222 Participants
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
n=205 Participants
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
n=206 Participants
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score
|
-0.58 Units on a Scale
Standard Deviation 0.63
|
-0.59 Units on a Scale
Standard Deviation 0.63
|
-0.42 Units on a Scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).
AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The AQLQ(S) Total score was the mean of the individual 32 questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=223 Participants
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
n=205 Participants
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
n=208 Participants
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score
|
0.51 Units on a Scale
Standard Deviation 0.70
|
0.61 Units on a Scale
Standard Deviation 0.70
|
0.50 Units on a Scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 12-week Treatment PeriodPopulation: Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).
Baseline was the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0 = no awakenings to 1 = awakenings every night. The comparison was for MF/F versus placebo. Standard deviation was pooled.
Outcome measures
| Measure |
MF/F MDI 400/10 mcg BID
n=255 Participants
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
n=233 Participants
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
n=239 Participants
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)
|
-0.10 Proportion of nights
Standard Deviation 0.17
|
-0.10 Proportion of nights
Standard Deviation 0.17
|
-0.05 Proportion of nights
Standard Deviation 0.17
|
Adverse Events
MF/F MDI 400/10 mcg BID
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
MF/F MDI 200/10 mcg BID
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
MF MDI 400 mcg BID
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Open-Label MF MDI 400 mcg BID
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MF/F MDI 400/10 mcg BID
n=255 participants at risk
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
n=233 participants at risk
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
n=240 participants at risk
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
Open-Label MF MDI 400 mcg BID
n=834 participants at risk
Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.43%
1/233 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.42%
1/240 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.42%
1/240 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
General disorders
Chest Pain
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.42%
1/240 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Injury, poisoning and procedural complications
Drug Exposure During Pregnancy
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.43%
1/233 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.43%
1/233 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.43%
1/233 • Number of events 2 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.39%
1/255 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.39%
1/255 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.42%
1/240 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/834 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.12%
1/834 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.12%
1/834 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.12%
1/834 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/255 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/233 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.00%
0/240 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.12%
1/834 • Number of events 1 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
Other adverse events
| Measure |
MF/F MDI 400/10 mcg BID
n=255 participants at risk
Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF/F MDI 200/10 mcg BID
n=233 participants at risk
Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
|
MF MDI 400 mcg BID
n=240 participants at risk
Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
|
Open-Label MF MDI 400 mcg BID
n=834 participants at risk
Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.7%
12/255 • Number of events 13 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
3.4%
8/233 • Number of events 8 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
5.4%
13/240 • Number of events 14 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
0.72%
6/834 • Number of events 6 • Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
834 participants enrolled in the OL Run-In Period, of which 728 participants completed and were randomized into 3 arms and treated in the DB treatment period. AEs were reported separately for the OL Run-In Period arm and the Treatment Period arms.
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60