Trial Outcomes & Findings for Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212) (NCT NCT01566149)
NCT ID: NCT01566149
Last Updated: 2024-05-24
Results Overview
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
COMPLETED
PHASE3
49 participants
Up to Week 14
2024-05-24
Participant Flow
Participants were recruited from one study site in Vietnam between March 2012 and September 2012.
Participants who were previously on medium-dose asthma medication were assigned to Mometasone Furoate/Formoterol Fumarate (MF/F) 200/10 mcg Metered Dose Inhaler (MDI) twice daily (BID) and participants who were previously on high-dose asthma medication were assigned to MF/F 400/10 mcg MDI BID.
Participant milestones
| Measure |
MF/F 200/10 mcg MDI BID
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
MF/F 200/10 mcg MDI BID
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Non-compliance with study medication
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
Baseline characteristics by cohort
| Measure |
MF/F 200/10 mcg MDI BID
n=24 Participants
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
n=25 Participants
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 14.48 • n=99 Participants
|
41.2 years
STANDARD_DEVIATION 14.91 • n=107 Participants
|
38.3 years
STANDARD_DEVIATION 14.84 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Outcome measures
| Measure |
MF/F 200/10 mcg MDI BID
n=24 Participants
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
n=25 Participants
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Number of Participants With At Least One Adverse Event (AE)
|
5 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.
A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Outcome measures
| Measure |
MF/F 200/10 mcg MDI BID
n=24 Participants
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
n=25 Participants
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Number of Participants With At Least One Drug-Related AE
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.
A serious AE was defined as any untoward medical occurrence or effect that at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.
Outcome measures
| Measure |
MF/F 200/10 mcg MDI BID
n=24 Participants
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
n=25 Participants
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Number of Participants With At Least One Serious AE
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Outcome measures
| Measure |
MF/F 200/10 mcg MDI BID
n=24 Participants
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
n=25 Participants
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Number of Participants Who Discontinued From the Study Due to an AE
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication and had at least one efficacy measurement post-dose.
Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.
Outcome measures
| Measure |
MF/F 200/10 mcg MDI BID
n=24 Participants
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
n=25 Participants
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Baseline FEV1
|
2.397 liters
Standard Deviation 0.6824 • Interval 0.006 to 0.214
|
2.215 liters
Standard Deviation 0.6206 • Interval -0.051 to 0.153
|
|
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Week 12 FEV1
|
2.503 liters
Standard Deviation 0.7418
|
2.270 liters
Standard Deviation 0.6041
|
|
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Change from Baseline in FEV1 at Week 12
|
0.106 liters
Standard Deviation 0.2892
|
0.054 liters
Standard Deviation 0.2055
|
Adverse Events
MF/F 200/10 mcg MDI BID
MF/F 400/10 mcg MDI BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MF/F 200/10 mcg MDI BID
n=24 participants at risk
Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
|
MF/F 400/10 mcg MDI BID
n=25 participants at risk
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.2%
1/24 • Number of events 1 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
8.0%
2/25 • Number of events 2 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
8.0%
2/25 • Number of events 2 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
3/24 • Number of events 4 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
8.0%
2/25 • Number of events 2 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
4.2%
1/24 • Number of events 1 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
8.0%
2/25 • Number of events 2 • Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER