Paediatric Subjects with Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Fluticasone Furoate
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: FLUTICASONE FUROATE
CAS Number: 397864-44-7
Current Sponsor code: GW685698X
Concentration unit: µg microgr
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects. 2. Age: a. Males between 5 and 19. 10. Patients should have required at least one course of corticosteroid for their asthma (inhaled or oral) in the past year. ? There must be no ICS use within 6 weeks of Visit 1 (Screening). ? There must be no oral corticosteroids use within 12 weeks of Visit 1 (Screening) 11. Using one or more of the following asthma therapies prior to entry into the study: ? Short acting beta-agonist (SABA) inhaler alone (e.g. salbutamol) on an as needed basis and/or ? Regular non-ICS controller medications for asthma (e.g. cromones or leukotriene receptor antagonists). 12. Written informed consent from at least one parent/care giver (legal guardian) and accompanying informed assent from the subject (where the subject is able to provide assent) prior to admission to the study. ? If applicable, subject must be able and willing to give assent to take part in the study according to local requirement. The study investigator is accountable for determining a child's capacity to assent for participation in a research study, taking into consideration any standards set by the responsible IEC. ? Subject and their legal guardian(s) understand that they must comply with study medication administration regimens and study assessments including recording of symptom scores and rescue albuterol/salbutamol use, attending all study visits, and being accessible by telephone. Are the trial subjects under 18? yes Number of subjects for this age range: 900 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: 1. Growth Criteria: a. Any previous or current condition that affects growth, including sleep disorders, endocrine disorders, skeletal dysplasia, Turner and Noonan syndromes, Marfan, Beckwith–Wiedeman and Sotos syndromes, Klinefelter’s syndrome, coeliac disease, inflammatory bowel diseases and renal failure or any significant abnormality or medical condition that is identified at the screening medical assessment (including serious psychological disorder) that is likely to interfere with the conduct of the study. b. Subjects with premature adrenarche (further details will be provided in the SRM). c. A child who is unable to stand, or who finds standing difficult due to illness or physical disabilities should be excluded. 2. Disease Criteria: a. Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or use of a depot corticosteroid injection within 3 months or those requiring hospitalisation for asthma (within 6 months) prior to screening. b. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject’s asthma status or the subject’s ability to participate in the study. c. Clinical visual evidence of candidiasis at Visit 1 (Screening). d. Any significant abnormality or medical condition identified at the screening medical assessment that in the Investigator’s opinion, preclude entry into the study due to risk to the subject or that may interfere with the outcome of the study. 3. General: a. Prior use of any medication or treatment that might affect growth including, but not limited to: amphetamines, anticonvulsants, biphosphonates, calcitonin, erythropoietin, growth hormone, methylphenidate, phosphate binders, antithyroid drugs (e.g., Methimazole) or thyroid hormone. 4. Use of any of the prohibited medications listed in Section 6.10.2. 5. Hypersensitivity: Known hypersensitivity to corticosteroids, leukotrienes, or any excipients in the ELLIPTA inhaler and study tablets. 6. Milk Protein Allergy: History of severe milk protein allergy. 7. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 8. Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day. 9. Children who are an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. 10. The Parent or Guardian has a history of known or suspected psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect: ? validity of consent to participate in the study ? adequate supervision of the subject during the study ? compliance of subject with study medication and study procedures (e.g.completion of daily diary, attending scheduled clinic visits) ? subject safety and well-being 11. Children in care: Children who are wards of the government or state are not eligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the magnitude of effect (with a level of precision) of inhaled FF 50 mcg versus inhaled placebo OD on growth velocity in prepubertal children over one year of treatment;Secondary Objective: To assess the safety of inhaled FF 50 mcg OD;Primary end point(s): ?Growth Velocity (cm/yr) over the doubleblind treatment period, as determined by stadiometry ;Timepoint(s) of evaluation of this end point: Entire treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Proportion of subjects below the 3rd percentile of growth velocity ? Change in growth velocity quartiles from baseline to endpoint ? Growth velocity over the first 12 weeks of double-blind treatment period ? Height standard deviation scores (SDS) at each visit ? Incidence of adverse events ? Incidence of asthma exacerbations;Timepoint(s) of evaluation of this end point: Entire treatment period. | — |
Countries
Argentina, Poland, Romania, Russian Federation, South Africa, United States
Contacts
Public ContactGSK Clinical Support Helpdesk
GlaxoSmithKline Research & Development Limited
Outcome results
None listed