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: Vilanterol/GW642444
Product Code: GW642444
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Vilanterol trifenatate
CAS Number: 503070-58-4
Current Sponsor code:
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and pre-menarchial female subjects aged 5–11 years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less. 2. Diagnosis of asthma at least 6 months prior to screening. 3. Patients must be controlled on their existing asthma treatment at Screening as defined by a Childhood Asthma Control Test score of >19 and PEF >75 % predicted. 4. Subjects must be taking a stable regimen of fluticasone propionate (up to =200 µg twice daily; no more than 400 µg total daily dose) or an equivalent corticosteroid and a short acting beta-agonist inhaler on an as-needed basis for at least 4 weeks prior to screening. 5. Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions. 6. Subjects must weigh at least 15 kg. 7. Subjects must demonstrate ability to accept and effectively use the GW642444 device using the demonstration kits provided to the site. 8. The subject and parent or 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 also have the ability to manage study drug administration and PEF assessments. 9. At least one parent or 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. 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 currently receiving (or have received within 4 weeks of screening) any of the following asthma therapies: theophyllines, long-acting inhaled beta-agonists, oral beta-agonist. 2. Subjects who have changed their asthma medication within 4 weeks of screening. 3. Clinical visual evidence of oral candidiasis at screening. 4. Any clinically relevant abnormality identified on the screening medical assessment 5. Any medical condition or circumstance making the subject unsuitable for participation in the study (e.g. history of life-threatening asthma) 6. Asthma exacerbation requiring systemic corticosteroids (oral, intramuscular, intravenous) or Emergency Room attendance within 3 months or asthma exacerbation requiring hospitalization within 6 months prior to the screening visit. 7. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract which is not resolved within 4 weeks of the screening visit. 8. Any adverse reaction including immediate or delayed hypersensitivity to any betaagonist therapy. 9. Known or suspected sensitivity to the constituents of the novel dry powder inhaler (i.e., lactose or magnesium stearate), for example, history of severe milk protein allergy. 10. The parent or guardian has history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g., inability to read, comprehend or write) which will limit the validity of consent to participate in this study. 11. A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. 12. Children who are wards of the state or government. 13. Evidence of clinically significant abnormality in the 12-lead ECG at Screening, as follows: i. Ventricular rate 115 bpm if aged 5–7 years. ii. Ventricular rate 110bpm if aged 8–11 years. iii. PR interval >160 msec if aged 5–7 years. iv. PR interval >170 msec if aged 8–11 years. v. QRS >100 msec. vi. Evidence of Mobitz II second degree or third degree AV block. vii. Evidence of =2 unifocal ventricular ectopic beats, couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. viii. QTc(B) >450 msec or an ECG that is not suitable for QT measurements (e.g. poor defined termination of the T wave). ix. Right or left complete bundle branch block. x. Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome). xi. Clinically significant arrhythmias (e.g. atrial fibrillation, atrial flutter, ventricular tachycardia). xii. Non-sustained ventricular tachycardia (3 or more consecutive ventricular beats greater than 100 bpm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability following administration of GW642444 25 µg, via a novel dry powder inhaler, once-daily for 7 days in subjects aged 5–11 years.;Secondary Objective: • To characterise the pharmacokinetics of GW642444 25 µg, following administration via a novel dry powder inhaler, once-daily for 7 days in subjects aged 5–11 years. • To determine the effects of administration of GW642444 25 µg, via a novel dry powder inhaler, once-daily for 7 days on glucose and potassium in subjects aged 5–11 years. ;Primary end point(s): • Adverse events. • Clinical laboratory assessments (hematology, chemistry and urinalysis). • Peak expiratory flow on Days 1, 8 and 14. • Systolic Blood Pressure (BP). • Diastolic BP. • Heart rate at the following times: • Day 1 maximum and weighted mean at 0-2 h • Day 14 maximum and weighted mean at 0–2 h and 0-8 h. Electrocardiographic (ECG) parameters: QT duration corrected for Fridericia’s formula (QTcF) at the following times: • Day 1 weighted mean and peak response at 0-2 h • Day 14 weighted mean and peak response at 0–2 h and 0-8 h.;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 and on Days 1, 8, and 14 in the clinic; Days 9-13 at home. •Systolic and diastolic blood pressure at screening, and Days 1, 8, and 14 •Heart rate and ECG at screening, and Days 1, 8 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pharmacokinetic parameters: maximum observed plasma GW642444 maximum observed concentration at steady-state (Cmaxss), area under the concentration-time curve (AUC)(0-t), AUC(0-8) and time of maximum observed concentration at steady state (Tmaxs) on Day14. • Glucose weighted mean 0–2 h and 0–8 h and maximum (0–2 h) and maximum (0– 8 h) on Day 14. • Potassium weighted mean 0–2 h and 0–8 h and minimum (0–2 h) and minimum (0– 8 h) on Day 14.;Timepoint(s) of evaluation of this end point: •GW642444 on Day 14 •Glucose and potassium on Day 14 | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Helpdesk
GlaxoSmithKline
Outcome results
None listed