Last updated: 11/03/2018 10:53:36
Clinical Assessment Of GW815SF Salmeterol/fluticasone propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A long term (24-week) study-
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical assessment of GW815SF Salmeterol/fluticasone propionate (HFA MDI) in pediatric patients with bronchial asthma -A long term (24-week) study-
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Most Frequent Adverse Events - On Therapy
Timeframe: Baseline to Week 24
Serious Adverse Events (SAEs) - On Therapy
Timeframe: Baseline to Week 24
Secondary outcomes:
Change from Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Timeframe: Baseline and during Weeks 1-24
Change from Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Timeframe: Baseline and during Weeks 1-24
Change from Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
Timeframe: Baseline and during Weeks 1-24
Change from Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
Timeframe: Baseline and during Weeks 1-24
Number of Participants with Symptom-Free Nights and Days
Timeframe: Baseline and Week 24
Number of Participants with Rescue Medication-Free Nights and Days
Timeframe: Baseline and Week 24
Interventions:
Drug: GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
2007-24-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Bronchial Asthma
Product
fluticasone propionate, salmeterol
Collaborators
Not applicable
Study date(s)
March 2007 to November 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
5 - 14 Years
Accepts healthy volunteers
No
- 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:
- Exclusion Criteria for Entry in Run-in Period
- A patient who applies any of the following criteria is not eligible for the study:
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Clinical Trials Call Center
Funabashi, Chiba, N/A, Japan, 273
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Setagaya, Tokyo, N/A, Japan, 157
Status
Recruitment Complete
Location
GSK Clinical Trials Call Center
Takasaki, Gunma, N/A, Japan, 370
Status
Recruitment Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-24-11
Actual study completion date
2007-24-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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