Asthma
Conditions
Interventions
Trade Name: Seretide® Evohaler®
Product Name: GW815SF (SLM/FP) HFA MDI
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: FLUTICASONE PROPIONATE
CAS Number: 80474-14-2
Other descriptive nam
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 51 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the equivalence by morning Peak Expiratory Flow (PEF), of one inhalation of GW815SF HFA MDI 25/50mcg twice daily to one inhalation of SLM DPI 25mcg twice daily plus one inhalation of FP DPI 50mcg twice daily in paediatric subjects with bronchial asthma in a crossover manner.;Secondary Objective: To determine the long-term safety of one inhalation of GW815SF HFA MDI 25/50mcg twice daily in paediatric subjects with bronchial asthma in the extension period following the crossover period.;Primary end point(s): Mean change from baseline in morning PEF over Weeks 1-4 in each treatment period (Treatment Periods 1 and 2) during the crossover period.;Timepoint(s) of evaluation of this end point: Crossover Period Weeks 1-4, and 7-10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percent predicted morning PEF, percent personal best morning PEF, evening PEF, circadian variation in PEF, percentage of subjects with symptom-free nights and days, percentage of subjects with rescue medication-free nights and days;Timepoint(s) of evaluation of this end point: Crossover Period Weeks 1-4, 7-10 and Extension period weeks 11-30 | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed