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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: salmeterol/fluticasone propionate
• Drug: GW815SF HFA MDI
• Drug: salmeterol and fluticasone propionate

Primary Measures

• Change from baseline in mean morning PEF during the 4-week treatment period

Secondary Measures

• Efficacy: Morning and evening PEF, Diurnal variation in PEF, Asthma symptoms, Rescue medication Safety: Adverse events, Clinical laboratory tests, Physical examinations, 12-lead ECG, Oropharyngeal test
• Efficacy: 1. Morning PEF (excluding the primary endpoint) 2. Percent morning PEF to predicted normal 3. Percent morning PEF to personal best
• 4. Evening PEF 5. Percent diurnal PEF variations 6. Percentages of symptom free nights and days
• 7. Percentages of nighttime or daytime symptom free subjects 8. Nighttime and daytime asthma symptom scores 9. Percentage of rescue medication free days
• 10. Percentage of subjects with no rescue medication use 11. Rescue medication use (number of use)
• Safety: 1. Adverse events (AEs) 2. Clinical laboratory tests (hematology, clinical chemistry) 3. Physical examinations (blood pressure, pulse rate)
• 4. 12-lead ECG 5. Oropharyngeal test (only if oral fungus infection is suspected)

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00448435

Study ID Number: 110099

ClinicalTrials.gov Identifier: NCT00448435

Health Authority: Japan: Ministry of Health, Labor and Welfare