Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT00448435
Eligibility Criteria:
Inclusion criteria:
* Inclusion Criteria for Entry in Run-in Period
A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study:
* Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing potential is allowed only if she is tested negative in the pregnancy testing at the start of Treatment Period 1 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail.
* Written informed consent must be obtained from a legally acceptable representative of the subject. Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner.
* An outpatient who has been treated with ICS (FP 100μg/day or equivalent) for at least 4 weeks prior to Visit 1.
* Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.
* Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.
Inclusion Criteria for Entry in Treatment Period 1 A subject will be randomized to one of the two treatment groups only if he/she has completed the run-in period and meets all the following criteria.
1. Has a mean of morning PEF measurements in the last 7 days of the run-in period (excluding the first day of Treatment Period 1) ≤90% of his/her best PEF measurement .
2. Was able to perform entry in the asthma diary and PEF measurements in a correct manner in the investigator's/subinvestigator's judgment.
3. Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.
Exclusion criteria:
* Exclusion Criteria for Entry in Run-in Period
A patient who applies any of the following criteria is not eligible for the study:
* Admitted to the hospital due to asthma exacerbation within 8 weeks prior to Visit 1.
* Used systemic steroid within 4 weeks prior to Visit 1.
* Received antibacterials or antivirals for treatment of upper or lower respiratory tract infection within 2 weeks prior to Visit 1.
* Has a safety problem in participation in the study because of a serious, uncontrolled systemic disease including nervous system disorder.
* Has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available.
* Has or is suspected to have hypersensitivity to the investigational product, rescue medication or any ingredients of them.
* Is pregnant or lactating, may be pregnant, or plans for pregnancy during the study period.
* Has received the last dose in another clinical study within 2 months prior to this study.
* Is not eligible for the study in the investigator's/subinvestigator's judgment.
Exclusion Criteria for Entry in Treatment Period 1
Enrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies:
1. Admitted to the hospital due to asthma exacerbation during the run-in period.
2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.
3. Used prohibited drugs during the 2 weeks just before Visit 2.
4. Is not eligible for the study in the investigator's/subinvestigator's judgment.
Exclusion Criteria for Entry in Treatment Period 2
Enrolment of a subject completing the washout period into Treatment Period 2 will not be allowed if any of the following applies:
1. Admitted to the hospital due to asthma exacerbation during the washout period.
2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4.
3. Used prohibited drugs during the 2 weeks just before Visit 4.
4. Is not eligible for entry in Treatment Period 2 in the investigator's/subinvestigator's judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
14 Years
Study:
NCT00448435
Study Brief:
Protocol Section:
NCT00448435