clinical assessment of gw815sf hfa mdi in pediatric patients with bronchial asthma

Conditions: Bronchial Asthma

Summary: 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.


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 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.

Keywords: salmeterol fluticasone propionate salmeterol/fluticasone propionate combination pediatric bronchial asthma