Trial Outcomes & Findings for Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418) (NCT NCT00394355)
NCT ID: NCT00394355
Last Updated: 2024-05-22
Results Overview
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
566 participants
Primary outcome timeframe
Baseline and up to ~ one year of treatment
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
MF DPI 200 mcg QD PM
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
140
|
137
|
147
|
142
|
|
Overall Study
COMPLETED
|
105
|
103
|
109
|
111
|
|
Overall Study
NOT COMPLETED
|
35
|
34
|
38
|
31
|
Reasons for withdrawal
| Measure |
MF DPI 200 mcg QD PM
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
7
|
8
|
|
Overall Study
Did not meet protocol eligibility
|
1
|
5
|
4
|
2
|
|
Overall Study
Subject withdrawal - unrelated to drug
|
12
|
14
|
10
|
6
|
|
Overall Study
Subject withdrawal - related to drug
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
4
|
3
|
|
Overall Study
Noncompliance with protocol
|
4
|
3
|
10
|
8
|
|
Overall Study
Administrative
|
0
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
3
|
Baseline Characteristics
Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)
Baseline characteristics by cohort
| Measure |
MF DPI 200 mcg QD PM
n=140 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
n=137 Participants
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
n=147 Participants
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
n=142 Participants
Montelukast (ML) 10 mg QD PM for 1 year
|
Total
n=566 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
29.8 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
28.2 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
28.2 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
29.0 years
STANDARD_DEVIATION 7.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
359 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
207 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to ~ one year of treatmentPopulation: All randomized participants
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
Outcome measures
| Measure |
MF DPI 200 mcg QD PM
n=117 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
n=121 Participants
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
n=131 Participants
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
n=127 Participants
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point
|
0.7 percentage of BMD
Standard Deviation 2.56
|
0.9 percentage of BMD
Standard Deviation 2.56
|
1.1 percentage of BMD
Standard Deviation 2.56
|
1.2 percentage of BMD
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Baseline and up to ~ one year of treatmentPopulation: All randomized participants
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
Outcome measures
| Measure |
MF DPI 200 mcg QD PM
n=117 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
n=121 Participants
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
n=130 Participants
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
n=127 Participants
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
|
0.3 percentage of BMD
Standard Deviation 2.00
|
0.2 percentage of BMD
Standard Deviation 2.00
|
0.2 percentage of BMD
Standard Deviation 2.00
|
0.5 percentage of BMD
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Baseline and up to ~ one year of treatmentPopulation: All randomized participants
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
Outcome measures
| Measure |
MF DPI 200 mcg QD PM
n=117 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
n=121 Participants
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
n=130 Participants
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
n=127 Participants
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
|
-0.2 percentage of BMD
Standard Deviation 3.17
|
0.4 percentage of BMD
Standard Deviation 3.17
|
-0.4 percentage of BMD
Standard Deviation 3.17
|
-0.2 percentage of BMD
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: Baseline and up to ~ one year of treatmentMean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward)
Outcome measures
| Measure |
MF DPI 200 mcg QD PM
n=140 Participants
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
n=136 Participants
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
n=146 Participants
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
n=141 Participants
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).
|
0.29 percentage of FEV1
Standard Deviation 0.43
|
0.38 percentage of FEV1
Standard Deviation 0.43
|
0.31 percentage of FEV1
Standard Deviation 0.43
|
0.19 percentage of FEV1
Standard Deviation 0.43
|
Adverse Events
MF DPI 200 mcg QD PM
Serious events: 5 serious events
Other events: 61 other events
Deaths: 0 deaths
MF DPI 400 mcg QD PM
Serious events: 2 serious events
Other events: 69 other events
Deaths: 0 deaths
FP MDI 250 mcg BID
Serious events: 4 serious events
Other events: 75 other events
Deaths: 0 deaths
ML 10 mg QD PM
Serious events: 8 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MF DPI 200 mcg QD PM
n=140 participants at risk
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
n=137 participants at risk
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
n=147 participants at risk
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
n=142 participants at risk
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Eye disorders
Lenticular opacities
|
0.00%
0/140
|
0.73%
1/137 • Number of events 1
|
0.00%
0/147
|
0.00%
0/142
|
|
Gastrointestinal disorders
Gastritis
|
0.71%
1/140 • Number of events 1
|
0.00%
0/137
|
0.00%
0/147
|
0.00%
0/142
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.71%
1/140 • Number of events 1
|
0.00%
0/137
|
0.00%
0/147
|
0.00%
0/142
|
|
Infections and infestations
Appendicitis
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/140
|
0.00%
0/137
|
0.68%
1/147 • Number of events 1
|
0.00%
0/142
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Keratitis herpetic
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
1.4%
2/140 • Number of events 2
|
0.00%
0/137
|
0.68%
1/147 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.71%
1/140 • Number of events 1
|
0.00%
0/137
|
0.00%
0/147
|
0.00%
0/142
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.4%
2/140 • Number of events 2
|
0.00%
0/137
|
0.68%
1/147 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/140
|
0.00%
0/137
|
0.68%
1/147 • Number of events 1
|
0.00%
0/142
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/140 • Number of events 1
|
0.00%
0/137
|
0.00%
0/147
|
0.00%
0/142
|
|
Psychiatric disorders
Depression
|
0.71%
1/140 • Number of events 1
|
0.00%
0/137
|
0.00%
0/147
|
0.00%
0/142
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.71%
1/140 • Number of events 1
|
0.00%
0/137
|
0.00%
0/147
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.71%
1/140 • Number of events 1
|
0.00%
0/137
|
0.00%
0/147
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/140
|
0.73%
1/137 • Number of events 1
|
0.00%
0/147
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/140
|
0.00%
0/137
|
0.68%
1/147 • Number of events 1
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/140
|
0.00%
0/137
|
0.68%
1/147 • Number of events 1
|
0.00%
0/142
|
|
Social circumstances
Victim of homicide
|
0.00%
0/140
|
0.00%
0/137
|
0.00%
0/147
|
0.70%
1/142 • Number of events 1
|
Other adverse events
| Measure |
MF DPI 200 mcg QD PM
n=140 participants at risk
Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
|
MF DPI 400 mcg QD PM
n=137 participants at risk
MF DPI 400 mcg QD PM for 1 year
|
FP MDI 250 mcg BID
n=147 participants at risk
Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
|
ML 10 mg QD PM
n=142 participants at risk
Montelukast (ML) 10 mg QD PM for 1 year
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
5/140 • Number of events 6
|
2.9%
4/137 • Number of events 5
|
5.4%
8/147 • Number of events 28
|
4.2%
6/142 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
4/140 • Number of events 12
|
5.1%
7/137 • Number of events 8
|
1.4%
2/147 • Number of events 3
|
1.4%
2/142 • Number of events 3
|
|
Infections and infestations
Bronchitis
|
2.1%
3/140 • Number of events 4
|
7.3%
10/137 • Number of events 12
|
4.8%
7/147 • Number of events 8
|
7.0%
10/142 • Number of events 13
|
|
Infections and infestations
Influenza
|
10.0%
14/140 • Number of events 16
|
7.3%
10/137 • Number of events 15
|
7.5%
11/147 • Number of events 13
|
9.2%
13/142 • Number of events 19
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
16/140 • Number of events 29
|
19.7%
27/137 • Number of events 45
|
17.7%
26/147 • Number of events 40
|
16.2%
23/142 • Number of events 32
|
|
Infections and infestations
Pharyngitis
|
12.1%
17/140 • Number of events 19
|
10.2%
14/137 • Number of events 19
|
7.5%
11/147 • Number of events 15
|
8.5%
12/142 • Number of events 15
|
|
Infections and infestations
Rhinitis
|
2.1%
3/140 • Number of events 4
|
4.4%
6/137 • Number of events 28
|
2.0%
3/147 • Number of events 6
|
6.3%
9/142 • Number of events 21
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
6/140 • Number of events 9
|
7.3%
10/137 • Number of events 15
|
4.8%
7/147 • Number of events 7
|
1.4%
2/142 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
4/140 • Number of events 4
|
7.3%
10/137 • Number of events 14
|
6.1%
9/147 • Number of events 11
|
2.8%
4/142 • Number of events 6
|
|
Nervous system disorders
Headache
|
15.7%
22/140 • Number of events 55
|
13.1%
18/137 • Number of events 38
|
12.9%
19/147 • Number of events 37
|
14.8%
21/142 • Number of events 93
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
7/140 • Number of events 12
|
6.6%
9/137 • Number of events 14
|
7.5%
11/147 • Number of events 35
|
4.9%
7/142 • Number of events 15
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigator (PI) agrees not to publish or publicly present any interim results of the study without prior written consent of the sponsor. The PI further agrees to provide to the sponsor, 30 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, PI agrees to meet with the sponsor, prior to submission for publication, to discuss and resolve any such issues or disagreement.
- Publication restrictions are in place
Restriction type: OTHER