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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Bronchial Asthma

Treatments: Drug: salmeterol and fluticasone propionate; Drug: GW815SF HFA MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448435

110099

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

51 participants in 3 patient groups

SLM+FP First

Active Comparator group

Description:

SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).

Treatment:

Drug: GW815SF HFA MDI

Drug: salmeterol and fluticasone propionate

SFC First

Active Comparator group

Description:

SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).

Treatment:

Drug: GW815SF HFA MDI

Drug: salmeterol and fluticasone propionate

SFC

Experimental group

Description:

SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).

Treatment:

Drug: GW815SF HFA MDI