bronchial asthma MedDRA version: 19.0 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855
Conditions
Sponsors
GlaxoSmithKline Research and development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the product label, add other pertinent documents. Deviations from inclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects eligible for enrolment in the study must meet all of the following criteria: 1.Obtaining consent: The written informed consent must be obtained from his/her parent or legally acceptable representative. If the investigator (or subinvestigator) obtains the oral consent from the patient, the investigator (or subinvestigator) should record so in the informed consent form which is signed by his/her parent or legally acceptable representative. 2.Race: Japanese 3.Age: = 6 months and =4 years at Visit 1. 4.Sex: Male and premenarcheal female. Premenarcheal females are defined as any female who has yet to have menstruation. 5.Patients: Outpatient 6.Diagnosis of asthma: Diagnosis of infantile bronchial asthma is made by reference to JPGL2012 and the rationale is documented. As for diagnosis of children of 200 micro g daily or equivalent) or continuous isoproterenol inhalation within 4 weeks prior to Visit 1. Are the trial subjects under 18? yes Num
Exclusion criteria
Exclusion criteria: Exclusion Criteria Deviations from exclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects meeting any of the following criteria must not be enrolled in the study: 1.Concomitant medication (infectious diseases): A patient who had upper or lower respiratory tract infection and received concomitant medication within 2 weeks prior to Visit 1. 2.Infectious diseases: A patient who has confirmatory diagnosis of upper or lower respiratory tract infection at Visit 1; or a patient who has or is suspected to have deep mycosis or infection for which no effective antibacterial agent is available; or a patient who is suspected to have RS virus infection and cannot be identified to be negative for RS virus antigen. 3.Respiratory comorbidities: A patient who has respiratory disorder other than bronchial asthma, and the respiratory disorder is likely to have an impact on the assessment of efficacy in this study. 4.Liver disease: A patient who has unstable liver disease or chronic stable hepatitis B, receiving immunosuppressive agents due to risk of hepatitis B reactivation. 5.Other comorbidities: A patient who has malformation/foreign particle in an airway; or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other abnormalities that are poorly controlled with standard treatment. 6.Drug allergy/ hypersensitivity: A patient who has or is suspected to have hypersensitivity to study medications, rescue medication or any ingredients of them. 7.Other studies/ study drug: A patient who participated in other studies/ trials and was treated with other investigational product(s) and 1 month has not elapsed at Visit 1 or the period of five-fold of the half-lives (t½) has not elapsed yet. 8.ECG: As for the patients who has evaluable ECG data at Visit 1, QTc(F) is =450 msec. If the first assessment meets this criterion, ECG should be measured two more times with interval after the first ECG, and the mean value of the three assessments will be used for judgement. As for the patients who do not have evaluable ECG data at Visit 1, if the patient has known prolonged QTc (=450 msec, any correction is valid), the patient will be excluded. 9.Other: A patient who is child in care (including foster parent system), or whom the investigator (or subinvestigator) judges inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of fluticasone propionate (FP)/ salmeterol xinafoate (SLM) HFA MDI 50/25 µg 1 or 2 inhalation twice daily for 8 weeks in comparison with FP HFA MDI 50 µg 1 or 2 inhalation twice daily in 6-month to 4-year-old Japanese patients with infantile bronchial asthma. In addition, the safety of long-term treatment of FP/ SLM HFA MDI 50/25 µg 1 or 2 inhalation twice daily will be evaluated in the 16 weeks of extension period. ;Secondary Objective: Not applicable;Primary end point(s): •Mean change from baseline in asthma symptom score (total of daytime and night-time) in patient diary at the end of the treatment period 1 among the subjects who have completed 8 weeks of treatment. The baseline value is the mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2). The value at the end of the treatment period 1 is the mean value of the last 7 consecutive days during the treatment period 1 (excluding the last day of the treatment period 1). The mean value of asthma symptom score (total of daytime and night-time) for at least 5 days is acceptable if some data are missing. ;Timepoint(s) of evaluation of this end point: At 8 weeks (visit 5/the end of period 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Mean change from baseline in night-time asthma symptom score •Mean change from baseline in daytime asthma symptom score •Frequency of asthma exacerbations •Use of rescue medication (number of occasions used during a 24-hour period and percentage of days with rescue-free 24-hour period) •QOL : Mean change from baseline in JPAC score ;Timepoint(s) of evaluation of this end point: At 8 weeks (visit 5/the end of period 1) | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed