Status:
COMPLETED
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Bronchial Asthma
Eligibility:
All Genders
5-14 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate...
Eligibility Criteria
Inclusion
- 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.
- 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 .
- Was able to perform entry in the asthma diary and PEF measurements 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.
- 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:
- Admitted to the hospital due to asthma exacerbation during the run-in period.
- Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.
- Used prohibited drugs during the 2 weeks just before Visit 2.
- 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:
- Admitted to the hospital due to asthma exacerbation during the washout period.
- Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4.
- Used prohibited drugs during the 2 weeks just before Visit 4.
- Is not eligible for entry in Treatment Period 2 in the investigator's/subinvestigator's judgment.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00448435
Start Date
April 1 2007
End Date
January 1 2008
Last Update
June 8 2010
Active Locations (8)
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1
GSK Investigational Site
Chiba, Japan, 260-0001
2
GSK Investigational Site
Kanagawa, Japan, 245-0018
3
GSK Investigational Site
Saitama, Japan, 360-0018
4
GSK Investigational Site
Saitama, Japan, 360-0812