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| ID | Type | Description | Link |
|---|---|---|---|
| 3462123 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF/F MDI 100/10 mcg BID with dose counter | Experimental | MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) | Drug | MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Discrepancy Rate | Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population). | 4-week Treatment Period |
| Overall Quartile Discrepancy Rate | Quartile discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded counter readout at each of the 4 weekly visit intervals [ie, quartiles] to evaluate whether there was any difference in agreement over the life of the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population. | 4-week Treatment Period |
| Overall Discrepancy Size | Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population. | 4-week Treatment Period |
| End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) | The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period. |
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Diagnosis and Criteria for Inclusion:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21398104 | Derived | Weinstein C, Staudinger H, Scott I, Amar NJ, LaForce C. Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD. Respir Med. 2011 Jul;105(7):979-88. doi: 10.1016/j.rmed.2011.01.013. Epub 2011 Mar 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MF/F MDI 100/10 mcg BID (With Dose Counter) | MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 4-week Treatment Period |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MF/F MDI 100/10 mcg BID (With Dose Counter) | MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period. |
| Units | Counts |
|---|---|
| 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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| Number of Participants with Asthma and Chronic Obstructive Pulmonary Disease (COPD) | Number | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Discrepancy Rate | Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population). | Completer population, defined as participants who recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period. | Posted | Number | Overall discrepancies per 100 actuations | 4-week Treatment Period |
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| Primary | Overall Quartile Discrepancy Rate | Quartile discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded counter readout at each of the 4 weekly visit intervals [ie, quartiles] to evaluate whether there was any difference in agreement over the life of the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population. | Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period. | Posted | Number | discrepancies per 100 actuations | 4-week Treatment Period |
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| Primary | Overall Discrepancy Size | Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population. | Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period. | Posted | Number | Discrepancy Size Per 100 actuations | 4-week Treatment Period |
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| Primary | End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) | The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period. | Completer Population, excluding 2 participants who used more than the labeled number of actuations. | Posted | Number | Number of inhalers | 4-week Treatment Period |
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6 weeks
Participants received open-label MF/F 100/10 mcg BID during the 2-week
Screening Period and the 4-week Treatment Period. All participants who received at least one dose of MF/F were included in the safety analysis.
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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 MDI 100/10 mcg BID | Included all participants that received 100/10 mcg BID (with and without dose counter) | 1 | 272 | 0 | 272 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema Peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp and Dohme Corp. | 1-800-672-6372 | clinicaltrialsresultsdisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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