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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0887A-206 | Other Identifier | Merck Study ID |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF/F 200/10 mcg MDI BID | Active Comparator | Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks |
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| MF/F 400/10 mcg MDI BID | Active Comparator | Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI | Drug | Two oral inhalations per dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
Participants were recruited from one study site in Vietnam between March 2012 and September 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | MF/F 200/10 mcg MDI BID | Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks |
| FG001 | MF/F 400/10 mcg MDI BID | Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI | Drug | Two oral inhalations per dose |
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| Baseline and Week 12 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MF/F 200/10 mcg MDI BID | Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks |
| BG001 | MF/F 400/10 mcg MDI BID | Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | 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. | The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication. | Posted | Number | participants | Up to Week 14 |
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| Primary | 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. | The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication. | Posted | Number | participants | Up to Week 14 |
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| Primary | 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. | The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication. | Posted | Number | participants | Up to Week 14 |
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| Primary | 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. | The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication. | Posted | Number | participants | Up to Week 12 |
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| Secondary | 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%. | 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. | Posted | Mean | Standard Deviation | liters | Baseline and Week 12 |
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Up to Week 14
The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MF/F 200/10 mcg MDI BID | Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks | 0 | 24 | 5 | 24 | ||
| EG001 | MF/F 400/10 mcg MDI BID | Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks | 0 | 25 | 8 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (15.0) |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D000068759 | Formoterol Fumarate |
| D000068758 | Mometasone Furoate, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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