A Phase 3 interventional study of Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI and Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI in Asthma, sponsored by Organon and Co. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the safety, tolerability \& effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults \& adolescents.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 49 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks
Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Two oral inhalations per dose
Also known as: Zenhale®, SCH 418131, MK-0887A
Two oral inhalations per dose
Also known as: Zenhale®, SCH 418131, MK-0887A
Number of Participants With At Least One Adverse Event (AE)
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.
Time frame: Up to Week 14
Number of Participants With At Least One Drug-Related AE
A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Time frame: Up to Week 14
Number of Participants With At Least One Serious AE
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.
Time frame: Up to Week 14
Number of Participants Who Discontinued From the Study Due to an AE
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.
Time frame: Up to Week 12
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
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%.
Time frame: Baseline and Week 12
Participants were recruited from one study site in Vietnam between March 2012 and September 2012.
| Milestone | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Started | 24 | 25 |
| Completed | 21 | 23 |
| Not completed | 3 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Non-compliance with study medication | 2 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| participants | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Number of Participants With At Least One Adverse Event (AE) | 5 | 8 |
A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
| participants | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Number of Participants With At Least One Drug-Related AE | 0 | 0 |
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.
| participants | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Number of Participants With At Least One Serious AE | 0 | 0 |
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.
| participants | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Number of Participants Who Discontinued From the Study Due to an AE | 0 | 1 |
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%.
| liters | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Baseline FEV1 | 2.397 ± 0.6824 | 2.215 ± 0.6206 |
| Week 12 FEV1 | 2.503 ± 0.7418 | 2.270 ± 0.6041 |
| Change from Baseline in FEV1 at Week 12 | 0.106 ± 0.2892 | 0.054 ± 0.2055 |
Collected over Up to Week 14. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MF/F 200/10 mcg MDI BID | — | 0/24 (0%) | 5/24 (20.8%) |
| MF/F 400/10 mcg MDI BID | — | 0/25 (0%) | 8/25 (32%) |
| Event | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 3/24 | 2/25 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/24 | 2/25 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/24 | 2/25 |
| Accidental overdoseInjury, poisoning and procedural complications | 1/24 | 2/25 |
| Age, Continuous(years) | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID | Total |
|---|---|---|---|
| Mean | 35.4 ± 14.48 | 41.2 ± 14.91 | 38.3 ± 14.84 |
| Sex: Female, Male(Participants) | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID | Total |
|---|---|---|---|
| Female | 14 | 12 | 26 |
| Male | 10 | 13 | 23 |
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