Trial Outcomes & Findings for A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828) (NCT NCT00521599)
NCT ID: NCT00521599
Last Updated: 2024-05-23
Results Overview
Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
672 participants
Primary outcome timeframe
Baseline and Week 8 End
Results posted on
2024-05-23
Participant Flow
Participant milestones
| Measure |
MF DPI 2 x 100 mcg BID
2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
|
MF DPI 1 x 200 mcg BID
1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
|
Placebo BID
2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
268
|
268
|
136
|
|
Overall Study
COMPLETED
|
243
|
239
|
100
|
|
Overall Study
NOT COMPLETED
|
25
|
29
|
36
|
Reasons for withdrawal
| Measure |
MF DPI 2 x 100 mcg BID
2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
|
MF DPI 1 x 200 mcg BID
1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
|
Placebo BID
2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
6
|
|
Overall Study
Treatment Failure
|
8
|
9
|
22
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
1
|
|
Overall Study
Withdrawal by subject treatment related
|
3
|
1
|
2
|
|
Overall Study
Protocol Violation
|
2
|
4
|
2
|
|
Overall Study
Did not meet protocol eligibility
|
2
|
2
|
1
|
Baseline Characteristics
A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828)
Baseline characteristics by cohort
| Measure |
MF DPI 2 x 100 mcg BID
n=268 Participants
2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
|
MF DPI 1 x 200 mcg BID
n=268 Participants
1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
|
Placebo BID
n=136 Participants
2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
Total
n=672 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
259 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
645 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
464 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8 EndPopulation: All treated subjects included all but one placebo-treated subject from the All Randomized Subjects data set, who was randomized, but never treated in either the open-label or double-blind Treatment Periods due to non-compliance with the protocol
Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.
Outcome measures
| Measure |
MF DPI 2 x 100 mcg BID
n=268 Participants
2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
|
MF DPI 1 x 200 mcg BID
n=268 Participants
1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
|
Placebo BID
n=136 Participants
2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
|---|---|---|---|
|
Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.
Baseline
|
361.8 liters/minute
Standard Deviation 96.7
|
374.3 liters/minute
Standard Deviation 96.7
|
348.4 liters/minute
Standard Deviation 96.7
|
|
Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.
Week 8 End
|
6.03 liters/minute
Standard Deviation 37.0
|
7.65 liters/minute
Standard Deviation 37.0
|
-7.93 liters/minute
Standard Deviation 37.0
|
Adverse Events
OL 1 X 200 mcg BID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
MF DPI 2 x 100 mcg BID
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
MF DPI 1 x 200 Mcg BID
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OL 1 X 200 mcg BID
n=950 participants at risk
Open-label MF DPI 200 mcg BID
|
MF DPI 2 x 100 mcg BID
n=268 participants at risk
2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
MF DPI 1 x 200 Mcg BID
n=268 participants at risk
1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks
|
Placebo
n=135 participants at risk
2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
OESOPHAGEAL RUPTURE
|
0.00%
0/950
|
0.37%
1/268 • Number of events 1
|
0.00%
0/268
|
0.00%
0/135
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/950
|
0.00%
0/268
|
0.37%
1/268 • Number of events 1
|
0.00%
0/135
|
|
General disorders
CHEST PAIN
|
0.11%
1/950 • Number of events 1
|
0.00%
0/268
|
0.00%
0/268
|
0.00%
0/135
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/950
|
0.37%
1/268 • Number of events 1
|
0.00%
0/268
|
0.00%
0/135
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/950
|
0.00%
0/268
|
0.37%
1/268 • Number of events 1
|
0.00%
0/135
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/950
|
0.00%
0/268
|
0.00%
0/268
|
0.74%
1/135 • Number of events 1
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/950
|
0.00%
0/268
|
0.00%
0/268
|
0.74%
1/135 • Number of events 1
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.00%
0/950
|
0.00%
0/268
|
0.00%
0/268
|
0.74%
1/135 • Number of events 1
|
|
Injury, poisoning and procedural complications
OPEN FRACTURE
|
0.00%
0/950
|
0.00%
0/268
|
0.00%
0/268
|
0.74%
1/135 • Number of events 1
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/950
|
0.37%
1/268 • Number of events 1
|
0.00%
0/268
|
0.00%
0/135
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.11%
1/950 • Number of events 1
|
0.00%
0/268
|
0.00%
0/268
|
0.74%
1/135 • Number of events 1
|
Other adverse events
| Measure |
OL 1 X 200 mcg BID
n=950 participants at risk
Open-label MF DPI 200 mcg BID
|
MF DPI 2 x 100 mcg BID
n=268 participants at risk
2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
MF DPI 1 x 200 Mcg BID
n=268 participants at risk
1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks
|
Placebo
n=135 participants at risk
2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
|
|---|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
0.63%
6/950 • Number of events 6
|
3.7%
10/268 • Number of events 10
|
6.0%
16/268 • Number of events 16
|
4.4%
6/135 • Number of events 8
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.42%
4/950 • Number of events 4
|
3.7%
10/268 • Number of events 11
|
5.2%
14/268 • Number of events 14
|
7.4%
10/135 • Number of events 10
|
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 or publicly present any interim results of the study without the prior written consent of sponsor. The investigator further agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication. The sponsor has the right to review and comment. If the parties disagree, the investigator agrees to meet with the sponsor's representative in order to resolve such issues.
- Publication restrictions are in place
Restriction type: OTHER