Clinical assessment of fluticasone propionate/ salmeterol xinafoate HFA MDI in 6-month to 4-year-old Japanese patients with bronchial asthma
- Conditions
- bronchial asthmaMedDRA version: 19.0Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-003479-22-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Research and development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 370
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 < 2 years old, the following description in JPGL2012 should be referenced [Japanese Society of Pediatric Allergy and Clinical Immunology, 2011].
- There are 3 or more episodes of obvious expiratory wheezing, regardless of the presence of respiratory tract infection. It is also needed to confirm that there is asymptomatic period for about a week between episodes.
In addition to this finding, if there is at least one of the following findings, it is more helpful to diagnose infantile asthma,
- At least one of parents is diagnosed with bronchial asthma by a physician (including past history).
- Specific IgE antibody for inhalation antigen is detected in at least one of parents.
- The diseased child is diagnosed with atopic dermatitis by a physician (including past history).
- Specific IgE antibody for inhalation antigen is detected in the diseased child.
- High serum IgE level in the diseased child or his/her family (serum IgE level should be determined in consideration of age).
- Eosinophils and creola bodies found in the sputum (increased eosinophils in nasal discharge and peripheral blood will be referenced).
- Expiratory wheezing occurs when seemingly there is no airway infection.
- Expiratory wheezing and labored respiration or oxygen saturation are improved after beta-2 stimulant inhalation.
7.Treatment of asthma: A patient who needs to be treated with ICS/LABA and fulfils all of the following conditions,
•At least one documented asthma exacerbation in that the patient treated with systemic glucocorticosteroids, aminophylline intravenous drip infusion (continuous drip infusion) or continuous isoproterenol inhalation within the 12 months prior to Visit 1. Or a well-documented continuous treatment with ICS (FP 200-400 micro g daily or equivalent) within 12 months prior to Visit 1.
•The patient has not received systemic glucocorticosteroids, aminophylline intravenous drip infusion (continuous drip infusion), ICS (FP > 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method