Asthma MedDRA version: 17.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Fluticasone Furoate/Vilanterol (FF/VI)
Product Code: Fluticasone Furoate/Vilanterol (FF/VI)
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: FLUTICASONE FUROATE
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Healthy as determined by a study physician, based medical history, physical examination, laboratory testing, and ECG; with no significant medical condition apart from asthma, eczema, or rhinitis. A subject with a clinical abnormality or laboratory parameters outside the reference range for this study may be included if the Investigator and GSK Medical Monitor agree the finding is unlikely to introduce additional risk factors or interfere with the study procedures. 2. Male and pre-menarchial female subjects aged 5 to less than 12 years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has not begun menses and is considered Tanner Stage 2 or less. 3. Diagnosis of asthma at least 6 months prior to screening. 4. Stable asthma therapy (fluticasone propionate, total daily dose less than or equal to 400 mcg or equivalent) and short acting beta-agonist (SABA) inhaler for at least 4 weeks prior to screening. 5. Subjects must be controlled on their existing asthma treatment at screening, which will be continued during the run-in, washout and runout periods (but not during 25 active treatment periods). Control is defined as a Childhood Asthma Control Test score of >19 and PEF = 75% predicted. 6. Subjects must demonstrate an ability to accept and effectively use a demonstration inhaler from the demonstration kits provided. 7. Subjects must weigh at least 20 kg. 8. The subject and parent/guardian are able to understand and comply with protocol requirements, instructions, and protocol stated restrictions. The parent or guardian must have the ability to read, write, and record diary information collected throughout the study. The parent or guardian must have the ability to manage study drug administration and PEF assessments. 9. At least one parent/guardian has signed and dated the written informed consent prior to admission to the study. This will be accompanied by informed assent from the subject for children aged 7 to 11 years. Are the trial subjects under 18? yes Number of subjects for this age range: 26 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.Subjects with a history of life-threatening asthma, an asthma exacerbation requiring systemic corticosteroids or ER attendance (within 3 months) or requiring hospitalization (within 6 months) prior to screening. 2. Subjects with any medical condition or circumstance making the volunteer unsuitable for participation in the study. 3. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear, not resolved within 4 weeks of screening leading to a change in asthma management; or, in the opinion of the investigator, is likely to affect the subject's asthma status or ability to participate in the study. 4. Clinical visual evidence of oral candidiasis at screening. 5. Subjects currently receiving (or have received within 4 weeks of screening) asthma therapies including theophyllines, long-acting inhaled beta-agonists, oral beta-agonists, or who have changed their asthma medication within 4 weeks of screening. 6. Significant abnormality of rate, interval, conduction or rhythm in the 12-lead ECG, determined by the investigator in conjunction with the age and gender of the child and the assessment provided by the remote analysis service. 7. QTcF > 450 msec or an ECG not suitable for QT measurement (e.g. poorly defined termination of the T wave). 8. AST, ALT, alkaline phosphatase and bilirubin > 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 9. A known or suspected sensitivity to any constituents of the novel dry powder inhaler (i.e. lactose or magnesium stearate) (e.g. history of severe milk protein allergy) 10. Any adverse reaction including immediate or delayed hypersensitivity to any beta-2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy. 11. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. 12. Consumption of red wine, seville oranges, grapefruit or grapefruit juice, and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication. 13. The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer). 14. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. 15. Where participation in the study would result in donation of blood or blood products in excess of the lesser of 50mL or 3mL per kilogram within a 56 day period. 16. Parent/guardian has a history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g. inability to read, comprehend and write) which will limit the validity of consent to participate in this study. 17. Unwillingness or inability of the subject or parent/guardian to follow the procedures outlined in the protocol. 18. Subject who is mentally or legally incapacitated. 19. Children who are wards of the state or government. 20. A subject will not be eligible for this study if he/she is an immediate family m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of inhaled FF/VI 100/25mcg administered once daily in the morning for 14 days via a novel dry powder inhaler in subjects aged 5 to 11 years;Secondary Objective: • To characterise the pharmacokinetics of FF and VI following administration as combination via a novel dry powder inhaler, once-daily for 14 days in subjects aged 5 to 11 years. • To compare the systemic pharmacodynamic effects of administration of FF and FF/VI via a novel dry powder inhaler, once-daily for 14 days on glucose, potassium and cortisol in subjects aged 5 to 11 years.;Primary end point(s): Assessment of safety and tolerability, including: • Adverse events • Clinical laboratory measurements • Lung function (peak expiratory flow rate) on Day 1 (0-2 hr) and Day 14 (0-12 hr). • Heart rate, including: • Day 1 maximum 0-2 hr • Day 14 maximum 0-2 hr • Systolic and diastolic blood pressure 0-8 hr • Electrocardiographic (ECG) parameters, including QT duration corrected for Fredrica's formula (QTcF): • Day 1 maximum QTcF 0-2 hr • Day 14 maximum QTcF 0-2 hr;Timepoint(s) of evaluation of this end point: •Adverse events from start of investigational product until follow up contact •Clinical laboratory assessments at screening and on Day 14 •Peak expiratory flow at screening, on Day 1 and 14 in the clinic and Days 2-13 at home •Maximum heart rate and blood pressure at screening and Day 1 and 14 •Blood pressure at screening and on Day 1 and 14 in the clinic | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic parameters for FF and VI: maximum observed concentration at steady-state (Cmax), area under the concentration-time curve (AUC(0-t), AUC(0-4) and time of maximum observed concentration at steady state (Tmax) on Day14 • Glucose weighted mean 0–4 hr on Day 14 • Potassium weighted mean 0–4 hr on Day 14 • Serum cortisol weighted mean (0–12hr) on Day 14;Timepoint(s) of evaluation of this end point: FF and VI on Day 14 Glucose and potassium on Day 14 Serum cortisol on Day 14 | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Helpdesk
GlaxoSmithKline
Outcome results
None listed