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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007504-28 | EudraCT Number | ||
| MK-0887-086 | Other Identifier | Merck |
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The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF MDI 50 mcg BID | Experimental | Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks. |
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| MF MDI 100 mcg BID | Experimental | Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
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| MF MDI 200 mcg BID | Experimental | Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
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| MF DPI 100 mcg QD | Active Comparator | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. |
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| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg | Drug | MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo | PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27740721 | Result | Amar NJ, Shekar T, Varnell TA, Mehta A, Philip G. Mometasone furoate (MF) improves lung function in pediatric asthma: A double-blind, randomized controlled dose-ranging trial of MF metered-dose inhaler. Pediatr Pulmonol. 2017 Mar;52(3):310-318. doi: 10.1002/ppul.23563. Epub 2016 Oct 14. |
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A total of 583 participants were randomized; 5 participants were randomized in error and did not receive any doses of randomized study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | MF MDI 50 mcg BID | Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks. |
| FG001 | MF MDI 100 mcg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
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| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg | Drug | MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks |
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| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg | Drug | MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks |
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| Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg | Drug | MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks |
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| Placebo Metered Dose Inhaler (MDI) | Drug | Placebo MDI, 2 puffs BID for 12 weeks |
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| Placebo Dry Powder Inhaler (DPI) | Drug | Placebo DPI, 1 puff QD for 12 weeks |
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| Baseline and Week 12 |
| Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo | The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups. | Baseline and Week 12 |
| Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure. | Baseline and Week 12 |
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| FG002 | MF MDI 200 mcg BID | Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| FG003 | MF DPI 100 mcg QD | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. |
| FG004 | Placebo | Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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The Baseline Analysis Population consisted of all randomized participants who received at least one dose of randomized study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | MF MDI 50 mcg BID | Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| BG001 | MF MDI 100 mcg BID | Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| BG002 | MF MDI 200 mcg BID | Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| BG003 | MF DPI 100 mcg QD | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. |
| BG004 | Placebo | Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| BG005 | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure. | The Full Analysis Set (FAS) population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI or Placebo were included in this primary analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Predicted FEV1 | Baseline and Week 12 |
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| Secondary | Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo | PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups. | The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Liters/minute | Baseline and Week 12 |
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| Secondary | Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo | The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups. | The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure. | The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI 50 mcg or MF DPI were included in this secondary analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Predicted FEV1 | Baseline and Week 12 |
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Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
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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 MDI 50 mcg BID | Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. | 2 | 120 | 19 | 120 | ||
| EG001 | MF MDI 100 mcg BID | Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. | 1 | 113 | 18 | 113 | ||
| EG002 | MF MDI 200 mcg BID | Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. | 2 | 108 | 18 | 108 | ||
| EG003 | MF DPI 100 mcg QD | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. | 4 | 125 | 16 | 125 | ||
| EG004 | Placebo | Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. | 2 | 112 | 19 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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The investigator 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. | 1-800-672-6372 | 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 |
| D036501 | Metered Dose Inhalers |
| D058995 | Dry Powder Inhalers |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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| Male |
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| Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 100 mcg BID vs. Placebo | cLDA | <0.001 | cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union) | Mean Difference (Net) | 6.29 | 2-Sided | 95 | 3.05 | 9.53 | Superiority or Other (legacy) |
| Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 200 mcg BID vs. Placebo | cLDA | 0.001 | cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union) | Mean Difference (Net) | 5.34 | 2-Sided | 95 | 2.07 | 8.61 | Superiority or Other (legacy) |
| OG003 | Placebo | Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| OG004 | MF DPI 100 mcg QD | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. |
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| OG002 |
| MF MDI 200 mcg BID |
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| OG003 | Placebo | Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| OG004 | MF DPI 100 mcg QD | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. |
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