Asthma
Conditions
Brief summary
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.
Interventions
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bronchial asthma * FEV1/FVC must be 70% or more * \<10% decrease in FEV1 in response to inhalation of normal saline
Exclusion criteria
* Moderate or severe airflow limitation（FEV1\<60% predicted） * Heart attack or stroke in last 3 months * Uncontrolled hypertension, systolic BP\>200, or diastolic BP\>100 * known aortic aneurysm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL | Visit 1 (Day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Visit 1 (Day 1) | PC20 : the concentration of methacholine causing 20% fall in FEV1. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methacholine Chloride children with bronchial asthma
Methacholine Chloride (SK-1211) | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Methacholine Chloride |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.7 years STANDARD_DEVIATION 2.4 |
| Region of Enrollment Japan | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: Visit 1 (Day 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methacholine Chloride | The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL | 7 percentage of the subjects |
Secondary
The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation
Time frame: Visit 1 (Day 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methacholine Chloride | The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation | 7 percentage of the subjects |
Secondary
The Summary Statistics of PC20
PC20 : the concentration of methacholine causing 20% fall in FEV1.
Time frame: Visit 1 (Day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methacholine Chloride | The Summary Statistics of PC20 | 8.0674 mg/mL | Standard Deviation 11.7127 |