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The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methacholine Chloride | Experimental | children with bronchial asthma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methacholine Chloride (SK-1211) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL | The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer. For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more. The concentration of methacholine causing 20% fall in FEV1 is PC20. | Visit 1 (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation | Visit 1 (Day 1) | |
| The Summary Statistics of PC20 | PC20 : the concentration of methacholine causing 20% fall in FEV1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santen study sites | Osaka | Osaka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methacholine Chloride | children with bronchial asthma Methacholine Chloride (SK-1211) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who have inhaled the investigational drug at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methacholine Chloride | children with bronchial asthma Methacholine Chloride (SK-1211) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL | The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer. For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more. The concentration of methacholine causing 20% fall in FEV1 is PC20. | Posted | Number | percentage of the subjects | Visit 1 (Day 1) |
|
|
Visit 1 (Day 1)
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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 | Methacholine Chloride | children with bronchial asthma Methacholine Chloride (SK-1211) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver.17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager of Clinical Development Group | Santen Pharmaceutical Co., Ltd. | clinical@santen.co.jp |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D016210 | Methacholine Chloride |
| ID | Term |
|---|---|
| D008688 | Methacholine Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Visit 1 (Day 1) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation | Posted | Number | percentage of the subjects | Visit 1 (Day 1) |
|
|
|
| Secondary | The Summary Statistics of PC20 | PC20 : the concentration of methacholine causing 20% fall in FEV1. | Posted | Mean | Standard Deviation | mg/mL | Visit 1 (Day 1) |
|
|
|
| 0 |
| 10 |
| 7 |
| 10 |
| Choking sensation | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver.17.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver.17.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA/J ver.17.0 | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |