Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchial Asthma
Intervention: GW815SF HFA MDI (Drug); salmeterol and fluticasone propionate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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 DPI 50µg 1 inhalation bid in paediatric patients with asthma.
To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in
paediatric patients with asthma.
Clinical Details
Official title: A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Secondary outcome: Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment PeriodsAdjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods Percentage of Subjects With Symptom-Free Nights & Days Percentage of Subjects With Rescue Medication-Free Nights and Days Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Eligibility
Minimum age: 5 Years.
Maximum age: 14 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Chiba 260-0001, Japan
GSK Investigational Site, Kanagawa 245-0018, Japan
GSK Investigational Site, Saitama 360-0018, Japan
GSK Investigational Site, Saitama 360-0812, Japan
GSK Investigational Site, Tokyo 154-0002, Japan
GSK Investigational Site, Tokyo 154-0017, Japan
GSK Investigational Site, Tokyo 158-0083, Japan
GSK Investigational Site, Tokyo 158-0097, Japan
Additional Information
Starting date: April 2007
Last updated: June 3, 2010
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