Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Fluticasone propionate 100mcg; Drug: Vilanterol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573767

106853

Details and patient eligibility

About

This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.

Enrollment: 463 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent from at least one parent/ legal guardian to take part in the study.:
• Diagnosis of asthma
• pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
• Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total daily dose FP 200mcg or equivalent)

Exclusion criteria

• history of life-threatening asthma
• history of asthma exacerbation for asthma within 6 months prior to screening.
• Culture-documented or suspected bacterial or viral infection
• significant abnormality or medical condition
• Present use of any tobacco products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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463 participants in 4 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler

Treatment:

Drug: Vilanterol

Drug: Fluticasone propionate 100mcg

Arm 2

Active Comparator group

Description:

Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler

Treatment:

Drug: Vilanterol

Drug: Fluticasone propionate 100mcg

Arm 3

Active Comparator group

Description:

Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler

Treatment:

Drug: Vilanterol

Drug: Fluticasone propionate 100mcg

Arm 4

Placebo Comparator group

Description:

Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler

Treatment:

Drug: Placebo

Drug: Fluticasone propionate 100mcg