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

NCT ID: NCT01573767

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-04-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

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

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate 100mcg

Intervention Type: DRUG

all subjects recieve open-label Flovent twice daily duirng the run in and treatment period

Vilanterol

Intervention Type: DRUG

subjects will recieve 4 weeks via NDPI during treament period

Arm 2

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

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate 100mcg

Intervention Type: DRUG

all subjects recieve open-label Flovent twice daily duirng the run in and treatment period

Vilanterol

Intervention Type: DRUG

subjects will recieve 4 weeks via NDPI during treament period

Arm 3

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

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate 100mcg

Intervention Type: DRUG

all subjects recieve open-label Flovent twice daily duirng the run in and treatment period

Vilanterol

Intervention Type: DRUG

subjects will recieve 4 weeks via NDPI during treament period

Arm 4

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

Group Type: PLACEBO_COMPARATOR

Fluticasone propionate 100mcg

Intervention Type: DRUG

all subjects recieve open-label Flovent twice daily duirng the run in and treatment period

Placebo

Intervention Type: DRUG

Placebo inhalation powder during treatment period

Interventions

Fluticasone propionate 100mcg

all subjects recieve open-label Flovent twice daily duirng the run in and treatment period

Intervention Type: DRUG

Placebo

Placebo inhalation powder during treatment period

Intervention Type: DRUG

Vilanterol

subjects will recieve 4 weeks via NDPI during treament period

Intervention Type: 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Mission Viejo, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Orange, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

Aventura, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Columbus, Georgia, United States

GSK Investigational Site

Savannah, Georgia, United States

GSK Investigational Site

Normal, Illinois, United States

GSK Investigational Site

Shiloh, Illinois, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Nicholasville, Kentucky, United States

GSK Investigational Site

White Marsh, Maryland, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Spring, Texas, United States

GSK Investigational Site

Waco, Texas, United States

GSK Investigational Site

South Burlington, Vermont, United States

GSK Investigational Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Plata, Buenos Aires, Argentina

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

Nueve de Julio, Buenos Aires, Argentina

GSK Investigational Site

San Juan Bautista, Buenos Aires, Argentina

GSK Investigational Site

Mendoza, Mendoza Province, Argentina

GSK Investigational Site

Salta, Salta Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Berazategui, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Rosario, , Argentina

GSK Investigational Site

San Miguel de Tucumán, , Argentina

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Viña del Mar, , Chile

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Tbilisi, , Georgia

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Rosenheim, Bavaria, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Baunatal-Grossenritte, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Hamm, North Rhine-Westphalia, Germany

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

GSK Investigational Site

Wesel, North Rhine-Westphalia, Germany

GSK Investigational Site

Koblenz, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Geesthacht, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Neuhaus am Rennweg, Thuringia, Germany

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Kagawa, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Wakayama, , Japan

GSK Investigational Site

Zapopan, Jalisco, Mexico

GSK Investigational Site

Puebla, Pue, Puebla, Mexico

GSK Investigational Site

Villahermosa, Tabasco, Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

San Miguel, Lima region, Peru

GSK Investigational Site

Santiago de Surco, Lima region, Peru

GSK Investigational Site

Cebu City, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Bieńkówka, , Poland

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Oleśnica, , Poland

GSK Investigational Site

Ostrów Wielkopolski, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Zawadzkie, , Poland

GSK Investigational Site

Hato Rey, Puerto Rico, Puerto Rico

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Martin, , Slovakia

GSK Investigational Site

Vysoké Tatry, , Slovakia

GSK Investigational Site

Meyerspark, Gauteng, South Africa

GSK Investigational Site

CapeTown, , South Africa

GSK Investigational Site

Middelburg, , South Africa

GSK Investigational Site

Panorama, , South Africa

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

Countries

United States; Argentina; Chile; Georgia; Germany; Japan; Mexico; Peru; Philippines; Poland; Puerto Rico; Slovakia; South Africa; Ukraine

References

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.

Reference Type: DERIVED

PMID: 27044326 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

106853

Identifier Type: -

Identifier Source: org_study_id