Clinical trial NCT00449046: Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
Official title: Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchial Asthma
Keywords: salmeterol/fluticasone propionate combination
pediatric bronchial asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.


Eligibility 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 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail during the study period.
* Written informed consent must be obtained from the 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 100-200μg/day or equivalent) for at least 4 weeks prior to Visit 1.
* Is suitable, in the investigator's/subinvestigator's judgment, for treatment with GW815SF HFA MDI 25/50μg (administered as 2 inhalations of 25/50μg) bid.
* Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.
* Able to use MDI 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 A subject will be considered eligible for inclusion in the treatment period only if he/she has completed the run-in period and meets the following criterion.

1. Has been able, in the investigator's/subinvestigator's judgment, to make entries in the asthma diary and measure PEF, as directed, during the run-in period.

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

A subject who applies to any of the following criteria is not eligible for the study:

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.

Primary outcomes:
measure: Most Frequent Adverse Events - On Therapy
timeFrame: Baseline to Week 24
measure: Serious Adverse Events (SAEs) - On Therapy
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
timeFrame: Baseline and during Weeks 1-24
measure: Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
timeFrame: Baseline and during Weeks 1-24
measure: Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
timeFrame: Baseline and during Weeks 1-24
measure: Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
timeFrame: Baseline and during Weeks 1-24
measure: Number of Participants With Symptom-Free Nights and Days
timeFrame: Baseline and Week 24
measure: Number of Participants With Rescue Medication-Free Nights and Days
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Funabashi, Chiba
country: Japan
facility: GSK Clinical Trials Call Center
city: Setagaya, Tokyo
country: Japan
facility: GSK Clinical Trials Call Center
city: Takasaki, Gunma
country: Japan
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: