Asthma
Conditions
Interventions
Trade Name: Serevent
Pharmaceutical Form:
INN or Proposed INN: SALMETEROL XINAFOATE
CAS Number: 94749-08-3
Other descriptive name: SALMETEROL XINAFOATE
Concentration unit: µg microgram(s)
Concentrati
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 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. Are the trial subjects under 18? yes Number of subjects for this age range: 40 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of two inhalations of GW815SF (SLM/FP) HFA MDI 25/50mcg twice daily in paediatric subjects with bronchial asthma.;Secondary Objective: Not applicable;Primary end point(s): The primary objective of the study was the assessment of adverse events (AEs).;Timepoint(s) of evaluation of this end point: Baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Morning Peak Expiratory Flow (PEF), percent predicted 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: Baseline to Week 24 | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed