Last updated: 07/17/2024 15:10:10
Dose-ranging study of vilanterol (VI) inhalation powder in children
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A dose-ranging study of vilanterol (VI) inhalation powder in children aged 5-11 years with asthma on a background of inhaled corticosteroid therapy
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in daily pre-dose evening (PM) peak expiratory flow (PEF) from participant electronic daily diary averaged over the 4-week Treatment Period
Timeframe: Baseline; Week 1 up to Week 4
Secondary outcomes:
Change from Baseline in evening clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at the end of the 4-week Treatment Period in children who could perform the maneuver
Timeframe: Baseline; Week 4
Change from Baseline in the percentage of rescue-free 24-hour periods during the 4-week Treatment Period
Timeframe: Baseline; Week 1 up to Week 4
Change from Baseline in daily morning (AM) PEF averaged over the 4-week Treatment Period
Timeframe: Baseline; Week 1 up to Week 4
Change from Baseline in evening (PM) PEF over the last 7 days of the Treatment Period (Week 4)
Timeframe: Baseline; Week 4
Change from Baseline in AM PEF over the last 7 days of the Treatment Period (Week 4)
Timeframe: Baseline; Week 4
Change from Baseline in the percentage of symptom-free 24-hour periods during the 4-week Treatment Period
Timeframe: Baseline; Week 1 up to Week 4
Interventions:
Enrollment:
463
Primary completion date:
2014-28-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Oliver A, Covar R, Goldfrad C, Klein R, Pedersen S, Sorkness C, Tomkins S, VillarĂ¡n Ferreyros C, Grigg J . Randomized Trial of Once-Daily Vilanterol in Children with Asthma on Inhaled Corticosteroid Therapy. Respir Res. 2016;17(1):37.
Medical condition
Asthma
Product
fluticasone propionate, vilanterol
Collaborators
Not applicable
Study date(s)
April 2012 to April 2014
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
5 - 11 years
Accepts healthy volunteers
No
- Written informed consent from at least one parent/ legal guardian to take part in the study.:
- Diagnosis of asthma
- history of life-threatening asthma
- history of asthma exacerbation for asthma within 6 months prior to screening.
Inclusion and exclusion criteria
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 location(s)
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Ciudad AutĂ³noma de Buenos Aires, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Florencio Varela, Buenos Aires, Argentina, 1888
Status
Study Complete
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Hamm, Nordrhein-Westfalen, Germany, 59063
Status
Study Complete
Location
GSK Investigational Site
Hato Rey, Puerto Rico, Puerto Rico, 00917
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, 1900
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68163
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Nicholasville, Kentucky, United States, 40356
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Puente Alto - Santiago, RegiĂ³n Metro De Santiago, Chile, 8207257
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DBS
Status
Study Complete
Location
GSK Investigational Site
Santiago, RegiĂ³n Metro De Santiago, Chile, 7520349
Status
Study Complete
Location
GSK Investigational Site
Santiago de Surco, Lima, Peru, Lima 33
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Shiloh, Illinois, United States, 62269
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
White Marsh, Maryland, United States, 21162
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2014-28-04
Actual study completion date
2014-28-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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