Clinical trial NCT01573767: Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 463
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period
timeFrame: Baseline; Week 1 up to Week 4
measure: Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)
timeFrame: Baseline; Week 4
measure: Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)
timeFrame: Baseline; Week 4
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Mission Viejo
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: GSK Investigational Site
state: California
city: Aventura
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Normal
country: United States
facility: GSK Investigational Site
state: Illinois
city: Shiloh
country: United States
facility: GSK Investigational Site
state: Illinois
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Nicholasville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: White Marsh
country: United States
facility: GSK Investigational Site
state: Maryland
city: Columbia
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facility: GSK Investigational Site
state: Missouri
city: Omaha
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facility: GSK Investigational Site
state: Nebraska
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
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facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Pittsburgh
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facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
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facility: GSK Investigational Site
state: South Carolina
city: Orangeburg
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state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Spring
country: United States
facility: GSK Investigational Site
state: Texas
city: Waco
country: United States
facility: GSK Investigational Site
state: Texas
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Ciudad de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Florencio Varela
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Nueve de Julio
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: Berazategui
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Rosario
country: Argentina
facility: GSK Investigational Site
city: Salta
country: Argentina
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city: Tucuman
country: Argentina
facility: GSK Investigational Site
city: Puente Alto - Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
city: Tbilisi
country: Georgia
facility: GSK Investigational Site
city: Tbilisi
country: Georgia
facility: GSK Investigational Site
city: Tbilisi
country: Georgia
facility: GSK Investigational Site
city: Tbilisi
country: Georgia
facility: GSK Investigational Site
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Rosenheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Baunatal-Grossenritte
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Neu isenburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hamm
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Wesel
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neuhaus am Rennweg
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Kagawa
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Wakayama
country: Japan
facility: GSK Investigational Site
city: Zapopan
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Puebla, Pue
country: Mexico
facility: GSK Investigational Site
state: Puebla
city: Villahermosa
country: Mexico
facility: GSK Investigational Site
state: Tabasco
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Lima 27
country: Peru
facility: GSK Investigational Site
state: Lima
city: San Miguel
country: Peru
facility: GSK Investigational Site
state: Lima
city: Santiago de Surco
country: Peru
facility: GSK Investigational Site
state: Lima
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Bienkowka
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Olesnica
country: Poland
facility: GSK Investigational Site
city: Ostrow Wielkopolski
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Zawadzkie
country: Poland
facility: GSK Investigational Site
city: Hato Rey
country: Puerto Rico
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Vysoke Tatry
country: Slovakia
facility: GSK Investigational Site
city: Meyerspark
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: CapeTown
country: South Africa
facility: GSK Investigational Site
city: Middelburg
country: South Africa
facility: GSK Investigational Site
city: Panorama
country: South Africa
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhia
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhia
country: Ukraine
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Oliver AJ, Covar RA, Goldfrad CH, Klein RM, Pedersen SE, Sorkness CA, Tomkins SA, Villaran C, Grigg J. Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy. Respir Res. 2016 Apr 5;17:37. doi: 10.1186/s12931-016-0353-4.