Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma

Condition(s) targeted: Bronchial Asthma

Intervention: salmeterol/fluticasone propionate (Drug); GW815SF HFA MDI (Drug); salmeterol and fluticasone propionate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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

Primary outcome: Change from baseline in mean morning PEF during the 4-week treatment period

Secondary outcome:

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)

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.

GSK Clinical Trials Call Center, Kumagaya, Saitama 360, Japan

GSK Clinical Trials Call Center, Chiba, Chiba 260, Japan

GSK Clinical Trials Call Center, Setagaya, Tokyo 154, Japan

GSK Clinical Trials Call Center, Yokohama, Kanagawa 245, Japan

GSK Clinical Trials Call Center, Setagaya, Tokyo 158, Japan

Starting date: March 2007
Ending date: February 2008
Last updated: February 28, 2008