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| ID | Type | Description | Link |
|---|---|---|---|
| Doc ID: 3387777; | |||
| EUDRACT No: 2004-002930-21; |
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This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | MF DPI 400 mcg once a day (QD) in the evening (PM) |
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| Group 2 | Experimental | MF DPI 200 mcg QD PM |
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| Group 3 | Active Comparator | Fluticasone propionate (FP) metered dose inhaler (MDI) 250 mcg twice a day (BID) |
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| Group 4 | Active Comparator | ML 10 mg QD PM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mometasone furoate dry powder inhaler | Drug | 400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point | The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. | Baseline and up to ~ one year of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point | The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. | Baseline and up to ~ one year of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24565713 | Result | Maspero J, Backer V, Yao R, Staudinger H, Teper A. Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma. J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):649-55.e1. doi: 10.1016/j.jaip.2013.07.011. Epub 2013 Oct 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MF DPI 200 mcg QD PM | Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year |
| FG001 | MF DPI 400 mcg QD PM | MF DPI 400 mcg QD PM for 1 year |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| mometasone furoate dry powder inhaler | Drug | 200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. |
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| fluticasone propionate hydrofluoroalkane (HFA) | Drug | 250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year |
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| montelukast | Drug | 10 mg given once daily in the evening by mouth for 1 year. |
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| Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point | The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. | Baseline and up to ~ one year of treatment |
| Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second). | Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward) | Baseline and up to ~ one year of treatment |
| FG002 | FP MDI 250 mcg BID | Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year |
| FG003 | ML 10 mg QD PM | Montelukast (ML) 10 mg QD PM for 1 year |
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| ID | Title | Description |
|---|---|---|
| BG000 | MF DPI 200 mcg QD PM | Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year |
| BG001 | MF DPI 400 mcg QD PM | MF DPI 400 mcg QD PM for 1 year |
| BG002 | FP MDI 250 mcg BID | Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year |
| BG003 | ML 10 mg QD PM | Montelukast (ML) 10 mg QD PM for 1 year |
| BG004 | 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 | ||||||||||
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| 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 | Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point | The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. | All randomized participants | Posted | Mean | Standard Deviation | percentage of BMD | Baseline and up to ~ one year of treatment |
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| Secondary | Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point | The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. | All randomized participants | Posted | Mean | Standard Deviation | percentage of BMD | Baseline and up to ~ one year of treatment |
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| Secondary | Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point | The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. | All randomized participants | Posted | Mean | Standard Deviation | percentage of BMD | Baseline and up to ~ one year of treatment |
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| Secondary | Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second). | Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward) | Posted | Mean | Standard Deviation | percentage of FEV1 | Baseline and up to ~ one year of treatment |
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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) |
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| EG000 | MF DPI 200 mcg QD PM | Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year | 5 | 140 | 61 | 140 | ||
| EG001 | MF DPI 400 mcg QD PM | MF DPI 400 mcg QD PM for 1 year | 2 | 137 | 69 | 137 | ||
| EG002 | FP MDI 250 mcg BID | Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year | 4 | 147 | 75 | 147 | ||
| EG003 | ML 10 mg QD PM | Montelukast (ML) 10 mg QD PM for 1 year | 8 | 142 | 64 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lenticular opacities | Eye disorders | MedDRA 12.1 |
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| Gastritis | Gastrointestinal disorders | MedDRA 12.1 |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 |
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| Appendicitis | Infections and infestations | MedDRA 12.1 |
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| Bronchopneumonia | Infections and infestations | MedDRA 12.1 |
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| Herpes zoster | Infections and infestations | MedDRA 12.1 |
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| Keratitis herpetic | Infections and infestations | MedDRA 12.1 |
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| Pneumonia | Infections and infestations | MedDRA 12.1 |
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| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 12.1 |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 12.1 |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 |
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| Anxiety | Psychiatric disorders | MedDRA 12.1 |
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| Depression | Psychiatric disorders | MedDRA 12.1 |
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| Psychotic disorder | Psychiatric disorders | MedDRA 12.1 |
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| Suicidal ideation | Psychiatric disorders | MedDRA 12.1 |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.1 |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
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| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
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| Victim of homicide | Social circumstances | MedDRA 12.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 |
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| Bronchitis | Infections and infestations | MedDRA 12.1 |
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| Influenza | Infections and infestations | MedDRA 12.1 |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.1 |
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| Pharyngitis | Infections and infestations | MedDRA 12.1 |
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| Rhinitis | Infections and infestations | MedDRA 12.1 |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
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| Headache | Nervous system disorders | MedDRA 12.1 |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
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Principal investigator (PI) agrees not to publish or publicly present any interim results of the study without prior written consent of the sponsor. The PI further agrees to provide to the sponsor, 30 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, PI agrees to meet with the sponsor, prior to submission for publication, to discuss and resolve any such issues or 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 |
| D000068298 | Fluticasone |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
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| Male |
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Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.
Pooled Standard deviation from the ANOVA model with treatment effects.
| ANOVA |
| 0.644 |
| Superiority or Other (legacy) |
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| Participants |
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