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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.
This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period.
After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test.
Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| montelukast to placebo | Active Comparator | 14 days |
|
| Washout | No Intervention | 14 days | |
| Placebo to montelukast | Active Comparator | 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast to placebo | Drug | Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5) | Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator | up to 2 weeks |
| Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5) | Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator | up to 2 weeks |
| Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator | Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator | up to 2 weeks |
| Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10) | Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator | up to 2 weeks |
| Baseline Lung Function of FEV1 Before the Bronchodilator | baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator | up to 2 weeks |
| Baseline Lung Function of FEV1/FVC Before the Bronchodilator | baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator | up to 2 weeks |
| Baseline Lung Function in MMEF | Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change (%) of FEV1 After the Bronchodilator | Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100 | up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Man Yong Han | specify Unaffiliated | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast to Placebo | Montelukast to placebo: Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks |
| FG001 | Placebo to Montelukast | Placebo to montelukast: Subjects will receive matching placebo. Each treatment period consists of 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14days) |
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| Washout Period (14days) |
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| Second Intervention (14days) |
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Measure Analysis Population Description: two participants did not complete the second set test due to symptom aggravation
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects | All subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5) | Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator | Posted | Mean | Standard Deviation | kPa/L/s | up to 2 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 | Baseline Lung Function | Before placebo or montelukast administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. HAN, MAN YONG | CHA UNIVERSITY | 82-31-780-6262 | drmesh@gmail.com |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Placebo to montelukast | Drug | Subjects will receive matching placebo. Each treatment period consists of 2 weeks |
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| up to 2 weeks |
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Lung function (Forced Expiratory Volume 1, predicted %) | Mean | Standard Deviation | % |
|
| Lung function (Forced Expiratory Volume 1/Forced Vital Capacity, predicted %) | Mean | Standard Deviation | % |
|
| oscillometric lung function (Resistance at 5Hz, z-score) | Mean | Standard Deviation | z-score |
|
| oscillometric lung fuction(Reactance at 5Hz, z-score) | Mean | Standard Deviation | z-score |
|
Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks
|
|
| Primary | Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5) | Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator | Posted | Mean | Standard Deviation | kPa/L/s | up to 2 weeks |
|
|
|
| Primary | Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator | Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator | Posted | Mean | Standard Deviation | kPa/L/s | up to 2 weeks |
|
|
|
| Primary | Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10) | Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator | Posted | Mean | Standard Deviation | kPa/L/s | up to 2 weeks |
|
|
|
| Primary | Baseline Lung Function of FEV1 Before the Bronchodilator | baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator | Posted | Mean | Standard Deviation | L/s | up to 2 weeks |
|
|
|
| Primary | Baseline Lung Function of FEV1/FVC Before the Bronchodilator | baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator | Posted | Mean | Standard Deviation | none (ratio) | up to 2 weeks |
|
|
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| Primary | Baseline Lung Function in MMEF | Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator | Posted | Mean | Standard Deviation | L/s | up to 2 weeks |
|
|
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| Secondary | Relative Change (%) of FEV1 After the Bronchodilator | Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100 | Posted | Mean | Standard Deviation | % (relative change) | up to 2 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 2 Weeks After Placebo Administration | Subjects will receive placebo. Each treatment period consists of 2 weeks | 0 | 30 | 7 | 30 |
| EG002 | 2 Weeks After Montelukast Administration | Subjects will receive montelukast (4mg or 5mg) Each treatment period consists of 2 weeks | 0 | 32 | 1 | 32 |
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