Trial Outcomes & Findings for Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139) (NCT NCT00379288)
NCT ID: NCT00379288
Last Updated: 2024-05-20
Results Overview
AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
404 participants
Primary outcome timeframe
1 year
Results posted on
2024-05-20
Participant Flow
Subjects starting study are those subjects who completed screening procedures and randomized.
Participant milestones
| Measure |
MF/F 200/10 mcg BID
mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
MF/F 400/10 mcg BID
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
F/SC 250/50 mcg BID
fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
|
F/SC 500/50 mcg BID
F/SC 500/50 twice daily for 1 year
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
141
|
130
|
68
|
65
|
|
Overall Study
COMPLETED
|
122
|
108
|
58
|
57
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
10
|
8
|
Reasons for withdrawal
| Measure |
MF/F 200/10 mcg BID
mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
MF/F 400/10 mcg BID
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
F/SC 250/50 mcg BID
fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
|
F/SC 500/50 mcg BID
F/SC 500/50 twice daily for 1 year
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
2
|
0
|
|
Overall Study
Treatment Failure
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
0
|
|
Overall Study
Subject withdrew-unrelated to study drug
|
0
|
3
|
4
|
2
|
|
Overall Study
Subject withdrew-related to study drug
|
1
|
0
|
0
|
1
|
|
Overall Study
Noncompliance with protocol
|
8
|
6
|
2
|
1
|
|
Overall Study
Did not meet protocol eligibility
|
0
|
1
|
0
|
2
|
|
Overall Study
Administrative
|
2
|
2
|
0
|
1
|
Baseline Characteristics
Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
Baseline characteristics by cohort
| Measure |
MF/F 200/10 mcg BID
n=141 Participants
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
MF/F 400/10 mcg BID
n=130 Participants
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
F/SC 250/50 mcg BID
n=68 Participants
F/SC 250/50 twice daily for 1 year
|
F/SC 500/50 mcg BID
n=65 Participants
F/SC 500/50 twice daily for 1 year
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
35.5 years
STANDARD_DEVIATION 15.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearAEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.
Outcome measures
| Measure |
MF/F 200/10 mcg BID
n=141 Participants
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
MF/F 400/10 mcg BID
n=130 Participants
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
F/SC 250/50 mcg BID
n=68 Participants
F/SC 250/50 twice daily for 1 year
|
F/SC 500/50 mcg BID
n=65 Participants
F/SC 500/50 twice daily for 1 year
|
|---|---|---|---|---|
|
The Number of All Randomized Subjects Reporting Adverse Events (AEs).
Treatment-Emergent Adverse Events (TEAE)
|
109 participants
|
103 participants
|
56 participants
|
50 participants
|
|
The Number of All Randomized Subjects Reporting Adverse Events (AEs).
Related Adverse Events
|
40 participants
|
30 participants
|
16 participants
|
13 participants
|
|
The Number of All Randomized Subjects Reporting Adverse Events (AEs).
Severe Adverse Events
|
8 participants
|
5 participants
|
4 participants
|
4 participants
|
|
The Number of All Randomized Subjects Reporting Adverse Events (AEs).
Serious Adverse Events
|
7 participants
|
8 participants
|
4 participants
|
2 participants
|
Adverse Events
MF/F MDI 200/10 mcg BID
Serious events: 7 serious events
Other events: 93 other events
Deaths: 0 deaths
MF/F MDI 400/10 mcg BID
Serious events: 8 serious events
Other events: 82 other events
Deaths: 0 deaths
F/SC MDI 250/50 mcg BID
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
F/SC MDI 500/50 mcg BID
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MF/F MDI 200/10 mcg BID
n=141 participants at risk
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
MF/F MDI 400/10 mcg BID
n=130 participants at risk
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
F/SC MDI 250/50 mcg BID
n=68 participants at risk
F/SC 250/50 twice daily for 1 year
|
F/SC MDI 500/50 mcg BID
n=65 participants at risk
F/SC 500/50 twice daily for 1 year
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
IDIOPATHIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/141
|
0.77%
1/130 • Number of events 1
|
0.00%
0/68
|
0.00%
0/65
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/141
|
0.77%
1/130 • Number of events 1
|
0.00%
0/68
|
0.00%
0/65
|
|
Eye disorders
LENS DISORDER
|
0.00%
0/141
|
2.3%
3/130 • Number of events 3
|
1.5%
1/68 • Number of events 1
|
0.00%
0/65
|
|
Eye disorders
OCULAR HYPERTENSION
|
0.00%
0/141
|
0.77%
1/130 • Number of events 1
|
0.00%
0/68
|
0.00%
0/65
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/141
|
0.00%
0/130
|
1.5%
1/68 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
ASCITES
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
0.00%
0/65
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.00%
0/141
|
0.77%
1/130 • Number of events 1
|
0.00%
0/68
|
0.00%
0/65
|
|
General disorders
ELECTROCUTION
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
0.00%
0/65
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/141
|
0.00%
0/130
|
0.00%
0/68
|
1.5%
1/65 • Number of events 1
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
1.5%
1/68 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/141
|
0.77%
1/130 • Number of events 1
|
0.00%
0/68
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/141
|
0.00%
0/130
|
1.5%
1/68 • Number of events 1
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
VERTEBRAL INJURY
|
0.00%
0/141
|
0.77%
1/130 • Number of events 1
|
0.00%
0/68
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
0.00%
0/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
0.00%
0/65
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
0.00%
0/65
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
0.00%
0/68
|
0.00%
0/65
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/141
|
0.77%
1/130 • Number of events 1
|
0.00%
0/68
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.71%
1/141 • Number of events 1
|
0.00%
0/130
|
1.5%
1/68 • Number of events 1
|
0.00%
0/65
|
Other adverse events
| Measure |
MF/F MDI 200/10 mcg BID
n=141 participants at risk
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
MF/F MDI 400/10 mcg BID
n=130 participants at risk
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
|
F/SC MDI 250/50 mcg BID
n=68 participants at risk
F/SC 250/50 twice daily for 1 year
|
F/SC MDI 500/50 mcg BID
n=65 participants at risk
F/SC 500/50 twice daily for 1 year
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.8%
4/141 • Number of events 4
|
4.6%
6/130 • Number of events 9
|
4.4%
3/68 • Number of events 4
|
7.7%
5/65 • Number of events 6
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.1%
3/141 • Number of events 7
|
5.4%
7/130 • Number of events 10
|
4.4%
3/68 • Number of events 8
|
4.6%
3/65 • Number of events 3
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
2.1%
3/141 • Number of events 5
|
2.3%
3/130 • Number of events 4
|
5.9%
4/68 • Number of events 4
|
0.00%
0/65
|
|
General disorders
PYREXIA
|
5.7%
8/141 • Number of events 11
|
4.6%
6/130 • Number of events 6
|
5.9%
4/68 • Number of events 5
|
1.5%
1/65 • Number of events 2
|
|
Infections and infestations
BRONCHITIS
|
12.1%
17/141 • Number of events 23
|
15.4%
20/130 • Number of events 29
|
20.6%
14/68 • Number of events 17
|
10.8%
7/65 • Number of events 7
|
|
Infections and infestations
INFLUENZA
|
9.9%
14/141 • Number of events 23
|
10.0%
13/130 • Number of events 16
|
13.2%
9/68 • Number of events 13
|
16.9%
11/65 • Number of events 13
|
|
Infections and infestations
NASOPHARYNGITIS
|
20.6%
29/141 • Number of events 39
|
16.2%
21/130 • Number of events 34
|
19.1%
13/68 • Number of events 19
|
12.3%
8/65 • Number of events 9
|
|
Infections and infestations
PHARYNGITIS
|
10.6%
15/141 • Number of events 24
|
8.5%
11/130 • Number of events 11
|
13.2%
9/68 • Number of events 12
|
13.8%
9/65 • Number of events 9
|
|
Infections and infestations
RHINITIS
|
5.0%
7/141 • Number of events 10
|
5.4%
7/130 • Number of events 7
|
11.8%
8/68 • Number of events 9
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.5%
5/141 • Number of events 6
|
3.8%
5/130 • Number of events 9
|
7.4%
5/68 • Number of events 5
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.1%
10/141 • Number of events 13
|
4.6%
6/130 • Number of events 8
|
10.3%
7/68 • Number of events 11
|
4.6%
3/65 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.4%
2/141 • Number of events 2
|
2.3%
3/130 • Number of events 8
|
2.9%
2/68 • Number of events 6
|
6.2%
4/65 • Number of events 7
|
|
Nervous system disorders
HEADACHE
|
23.4%
33/141 • Number of events 77
|
23.8%
31/130 • Number of events 85
|
25.0%
17/68 • Number of events 47
|
20.0%
13/65 • Number of events 31
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.7%
8/141 • Number of events 13
|
1.5%
2/130 • Number of events 5
|
5.9%
4/68 • Number of events 4
|
3.1%
2/65 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
5.0%
7/141 • Number of events 25
|
3.8%
5/130 • Number of events 9
|
7.4%
5/68 • Number of events 5
|
3.1%
2/65 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
7.8%
11/141 • Number of events 20
|
5.4%
7/130 • Number of events 10
|
2.9%
2/68 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
7.8%
11/141 • Number of events 24
|
6.9%
9/130 • Number of events 18
|
8.8%
6/68 • Number of events 11
|
7.7%
5/65 • Number of events 5
|
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