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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
| New York State Department of Health | OTHER_GOV |
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Background: In recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the United States. Given the concurrent rise in the two epidemics, there may be an underlying link. Obesity contributes to asthma severity and control, and may play a role in its underlying cause. Obesity is associated with a state of heightened inflammation that may lead to an increase asthma symptoms and severity. Obese adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better asthma control than those treated with other standard asthma medications. The use of montelukast in obese children and adolescents has not been specifically studied.
Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and objective markers of asthma to a greater degree in obese, as opposed to non-obese children and adolescents. The investigators would like to determine if the use of montelukast will improve objective asthma scores, pulmonary function, markers of inflammation and medication use to a greater degree in obese as opposed to non-obese children/adolescents.
Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a tailored approach focused on obese asthmatic children may help reduce the burden of this disease, health care costs and potential long-term complications as these children enter adulthood. Furthermore, this study may help clarify the underlying mechanisms that link asthma and obesity. Although this proposal is focused on one medication, it provides an example of how certain medications may have differential efficacy in the obese asthmatic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese atopic asthmatics, montelukast | Experimental | Obese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion. |
|
| Lean atopic asthmatics, placebo | Placebo Comparator | Normal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion. |
|
| Lean atopic asthmatics, montelukast | Active Comparator | Normal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion. |
|
| Obese atopic asthmatics, Placebo | Placebo Comparator | Obese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | Age-dependent dose, nightly, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test (ACT) Scores | The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometric Measures | Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | 24 weeks |
| Serum Leptin Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry Farzan, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore-Long Island Jewish Health System, Division of Allergy/Immunology | Great Neck | New York | 11023 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28668546 | Derived | Farzan S, Khan S, Elera C, Tsang J, Akerman M, DeVoti J. Effectiveness of montelukast in overweight and obese atopic asthmatics. Ann Allergy Asthma Immunol. 2017 Aug;119(2):189-190. doi: 10.1016/j.anai.2017.05.024. Epub 2017 Jun 28. No abstract available. |
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Potential subjects underwent spirometry with bronchodilator administration if there was no previous documentation and allergy testing (skin/blood) to evaluate for environmental allergies.There was a four to six week run-in period where all participants were maintained on an inhaled corticosteroid before randomization.
Atopic asthmatics age seven and above seen in pulmonary and allergy clinics were approached over a 2.5 year period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overweight/Obese Atopic Asthmatics, Montelukast | Montelukast: Age-dependent dose, nightly, 24 weeks |
| FG001 | Normal-weight Atopic Asthmatics, Placebo | Placebo: Age-dependent dose, nightly, 24 weeks |
| FG002 | Normal Weight Atopic Asthmatics, Montelukast | Montelukast: Age-dependent dose, nightly, 24 weeks |
| FG003 | Overweight/Obese Atopic Asthmatics, Placebo | Placebo: Age-dependent dose, nightly, 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Obese Atopic Asthmatics, Montelukast | Montelukast: Age-dependent dose, nightly, 24 weeks |
| BG001 | Normal-weight Atopic Asthmatics, Placebo | Placebo: Age-dependent dose, nightly, 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Asthma Control Test (ACT) Scores | The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 weeks |
|
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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 | Overweight/Obese Atopic Asthmatics, Montelukast | Montelukast: Age-dependent dose, nightly, 24 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood changes | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherry Farzan, Attending Physician, Assistant Professor of Medicine and Pediatrics | North Shore - Long Island Jewish Health System; Hofstra North Shore-LIJ School of Medicine | 5166225070 | sfarzan@nshs.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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|
| Placebo | Drug | Age-dependent dose, nightly, 24 weeks |
|
| Montelukast | Drug | Age-dependent dose, nightly, 24 weeks |
|
|
| Placebo | Drug | Age-dependent dose, nightly, 24 weeks |
|
Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage. |
| 24 weeks |
| Urinary Leukotriene E4 (LTE4) Levels | LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | 24 weeks |
| Exhaled Nitric Oxide Measurement | A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | 24 weeks |
| Beclomethasone Equivalents | The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | 24 weeks |
| Urinary Creatinine (Cr) Levels | Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | 24 weeks |
| Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio | The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | 24 weeks |
| Withdrawal by Subject |
|
| Adverse Event |
|
| BG002 | Normal Weight Atopic Asthmatics, Montelukast | Montelukast: Age-dependent dose, nightly, 24 weeks |
| BG003 | Obese Atopic Asthmatics, Placebo | Placebo: Age-dependent dose, nightly, 24 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height (cm) | Median | Inter-Quartile Range | cm |
|
| Weight (kg) | Median | Inter-Quartile Range | kg |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| OG002 | Normal Weight Atopic Asthmatics, Montelukast | Montelukast: Age-dependent dose, nightly, 24 weeks |
| OG003 | Overweight/Obese Atopic Asthmatics, Placebo | Placebo: Age-dependent dose, nightly, 24 weeks |
|
|
| Secondary | Spirometric Measures | Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | Posted | Mean | 95% Confidence Interval | percent predicted | 24 weeks |
|
|
|
| Secondary | Serum Leptin Levels | Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage. | Posted | Mean | 95% Confidence Interval | ng/mL | 24 weeks |
|
|
|
| Secondary | Urinary Leukotriene E4 (LTE4) Levels | LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks. | Posted | Mean | 95% Confidence Interval | pg/mL | 24 weeks |
|
|
|
| Secondary | Exhaled Nitric Oxide Measurement | A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | Posted | Mean | 95% Confidence Interval | ppb | 24 weeks |
|
|
|
| Secondary | Beclomethasone Equivalents | The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | Posted | Mean | 95% Confidence Interval | micrograms | 24 weeks |
|
|
|
| Secondary | Urinary Creatinine (Cr) Levels | Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks. | Posted | Mean | 95% Confidence Interval | mg/mL | 24 weeks |
|
|
|
| Secondary | Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio | The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. | One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks. | Posted | Mean | 95% Confidence Interval | pg/mg | 24 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Normal-weight Atopic Asthmatics, Placebo | Placebo: Age-dependent dose, nightly, 24 weeks | 0 | 5 | 0 | 5 |
| EG002 | Normal Weight Atopic Asthmatics, Montelukast | Montelukast: Age-dependent dose, nightly, 24 weeks | 0 | 5 | 0 | 5 |
| EG003 | Overweight/Obese Atopic Asthmatics, Placebo | Placebo: Age-dependent dose, nightly, 24 weeks | 0 | 9 | 3 | 9 |
"You shall have the right to publish the results derived from your performance of the Study. You agree to submit a copy of...Study results ("Publication") to Merck for comment sixty (60) days prior to its submission for publication. Merck shall have the applicable sixty (60) day period to respond to you with any requested revisions. You agree to delete any confidential information (excluding results) identified by Merck as confidential prior to submitting/presenting the Publication....."
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| FVC% |
|
| FEV1/FVC |
|
| FEF 25-75% |
|
| PEF (peak expiratory flow)% |
|
| serum adiponectin |
|