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| ID | Type | Description | Link |
|---|---|---|---|
| SCH 418131 |
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This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF/F MDI 200/10 mcg BID | Experimental | Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily. |
|
| F/SC DPI 250/50 mcg BID | Active Comparator | Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate/formoterol (MF/F) MDI | Drug | MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1 | PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22152089 | Result | Bernstein DI, Hebert J, Cheema A, Murphy KR, Cherrez-Ojeda I, Matiz-Bueno CE, Kuo WL, Nolte H. Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma. Allergy Asthma Clin Immunol. 2011 Dec 7;7(1):21. doi: 10.1186/1710-1492-7-21. | |
| 36472162 |
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In order to standardize treatment prior to randomization, participants entered a 2- to 4-week open-label Run-in period where they received MF MDI 200 mcg BID. Participants who continued to meet eligibility criteria at the completion of the Run-in Period were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MF/F MDI 200/10 mcg BID | Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI). |
| FG001 | F/SC DPI 250/50 mcg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluticasone propionate/salmeterol (F/SC) DPI | Drug | Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks. |
|
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| Baseline to 5 minutes post-dose on Day 1 |
| Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint | The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period. | Baseline to Week 12 |
| The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period. | For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods. | Baseline to Week 12 |
| Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. |
Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MF/F MDI 200/10 mcg BID | Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI). |
| BG001 | F/SC DPI 250/50 mcg BID | Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) | Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle). The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate. | Posted | Least Squares Mean | Standard Deviation | Liter x hour | Baseline to Week 12 |
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| Secondary | Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1 | PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval. | Participants with data at Day One 5 minutes post-dose. The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate. | Posted | Least Squares Mean | Standard Deviation | Liters | Baseline to 5 minutes post-dose on Day 1 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint | The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period. | Efficacy analyses were based on randomized subjects with Baseline and any postbaseline data (intent-to-treat principle). The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline ACQ score as a covariate. | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period. | For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods. | Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle). The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline proportion of symptom-free days/nights as a covariate. | Posted | Least Squares Mean | Standard Deviation | Proportion of symptom-free days/nights | Baseline to Week 12 |
|
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This study included a 2 to 4-week open-label (OL) run-in period prior to randomization. The OL MF MDI 200 mcg BID group includes all screened participants who were administered at least one dose. Participants who continued to meet eligibility criteria at the completion of the OL run-in period were subsequently randomized to either MF/F or F/SC.
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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 | Open-label (OL) MF MDI * 200 MCG BID | Mometasone furoate 200 mcg taken twice daily (BID) via a metered-dose inhaler (MDI). | 0 | 983 | 43 | 983 | ||
| EG001 | MF/F MDI * 200/10 MCG * BID | Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI). | 6 | 371 | 85 | 371 | ||
| EG002 | F/SC DPI * 250/50 MCG BID | Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID | 8 | 351 | 77 | 351 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Skin Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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The sponsor closed the study early, at 12 weeks treatment, for reasons that were not safety related. No efficacy analysis of data collected beyond 12 weeks of treatment was performed. All safety data were examined regardless of treatment duration.
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 & 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 |
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol 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 |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Title | Measurements |
|---|---|
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| >=65 years |
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| Male |
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| Units | Counts |
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| Participants |
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