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

NCT01573767 | Completed Phase 2 Results

• 1 other identifier: 106853
• Study Type: interventional
• Target: 463
• Locations: 14 countries
• Sites: 120

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

Outcome Measures

Primary Outcomes (1)

• 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

  PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.

  Baseline; Week 1 up to Week 4

Secondary Outcomes (6)

• 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

  Baseline; Week 4

• Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period

  Baseline; Week 1 up to Week 4

• Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period

  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)

  Baseline; Week 4

• Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)

  Baseline; Week 4

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

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

Drug: Fluticasone propionate 100mcg; Drug: Vilanterol

Arm 2

ACTIVE COMPARATOR

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

Drug: Fluticasone propionate 100mcg; Drug: Vilanterol

Arm 3

ACTIVE COMPARATOR

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

Drug: Fluticasone propionate 100mcg; Drug: Vilanterol

Arm 4

PLACEBO COMPARATOR

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

Drug: Fluticasone propionate 100mcg; Drug: Placebo

Interventions

Fluticasone propionate 100mcg DRUG

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

Arm 1; Arm 2; Arm 3; Arm 4

Placebo DRUG

Placebo inhalation powder during treatment period

Arm 4

Vilanterol DRUG

subjects will recieve 4 weeks via NDPI during treament period

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (120)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

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Mobile, Alabama, 36608, United States

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Little Rock, Arkansas, 72205, United States

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Huntington Beach, California, 92647, United States

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Long Beach, California, 90808, United States

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Mission Viejo, California, 92691, United States

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Newport Beach, California, 92663, United States

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Orange, California, 92868, United States

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Rolling Hills Estates, California, 90274, United States

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Aventura, Florida, 33180, United States

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Miami, Florida, 33173, United States

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Tampa, Florida, 33613, United States

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Columbus, Georgia, 31904, United States

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Savannah, Georgia, 31406, United States

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Normal, Illinois, 61761, United States

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Shiloh, Illinois, 62269, United States

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Lenexa, Kansas, 66215, United States

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Nicholasville, Kentucky, 40356, United States

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White Marsh, Maryland, 21162, United States

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Columbia, Missouri, 65203, United States

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Omaha, Nebraska, 68107, United States

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Raleigh, North Carolina, 27607, United States

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Cincinnati, Ohio, 45231, United States

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Dayton, Ohio, 45414, United States

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Oklahoma City, Oklahoma, 73112, United States

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Medford, Oregon, 97504, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Charleston, South Carolina, 29406, United States

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Orangeburg, South Carolina, 29118, United States

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Austin, Texas, 78750, United States

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Dallas, Texas, 75230, United States

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Spring, Texas, 77379, United States

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Waco, Texas, 76712, United States

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South Burlington, Vermont, 05403, United States

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Ciudad de Buenos Aires, Buenos Aires, C1431FWO, Argentina

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La Plata, Buenos Aires, 1900, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Nueve de Julio, Buenos Aires, B6500BWQ, Argentina

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San Juan Bautista, Buenos Aires, 1888, Argentina

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Mendoza, Mendoza Province, M5500CCG, Argentina

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Salta, Salta Province, A4400ERH, Argentina

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Rosario, Santa Fe Province, S2000DBS, Argentina

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Rosario, Santa Fe Province, S2000JKR, Argentina

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Berazategui, 1886, Argentina

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Buenos Aires, C1121ABE, Argentina

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Buenos Aires, C1425BEN, Argentina

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Rosario, S2000BRH, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile

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Santiago, Región Metro de Santiago, 7520349, Chile

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Santiago, 8380453, Chile

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Viña del Mar, 2520594, Chile

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Tbilisi, 0119, Georgia

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Tbilisi, 0159, Georgia

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Tbilisi, 0160, Georgia

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Tbilisi, 0186, Georgia

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Mannheim, Baden-Wurttemberg, 68163, Germany

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Rosenheim, Bavaria, 83026, Germany

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Hamburg, Hamburg, 22415, Germany

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Baunatal-Grossenritte, Hesse, 34225, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Neu-Isenburg, Hesse, 63263, Germany

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Wolfenbüttel, Lower Saxony, 38302, Germany

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Bochum, North Rhine-Westphalia, 44791, Germany

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Hamm, North Rhine-Westphalia, 59063, Germany

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Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

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Wesel, North Rhine-Westphalia, 46483, Germany

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Koblenz, Rhineland-Palatinate, 56068, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04178, Germany

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Geesthacht, Schleswig-Holstein, 21502, Germany

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Berlin, State of Berlin, 10785, Germany

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Neuhaus am Rennweg, Thuringia, 98724, Germany

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Chiba, 260-0001, Japan

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Chiba, 273-0035, Japan

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Fukuoka, 811-1394, Japan

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Hiroshima, 720-8520, Japan

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Hokkaido, 006-0831, Japan

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Hokkaido, 064-0821, Japan

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Hyōgo, 653-0021, Japan

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Kagawa, 762-0031, Japan

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Tokyo, 154-0017, Japan

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Tokyo, 157-0066, Japan

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Tokyo, 158-0097, Japan

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Wakayama, 646-8558, Japan

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Zapopan, Jalisco, 45040, Mexico

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Puebla, Pue, Puebla, 72000, Mexico

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Villahermosa, Tabasco, 86100, Mexico

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Mexico City, 04530, Mexico

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Lima, Lima Province, Lima 1, Peru

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Lima, Lima Province, Lima 27, Peru

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San Miguel, Lima region, Lima 32, Peru

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Santiago de Surco, Lima region, Lima 33, Peru

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Cebu City, 6000, Philippines

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Manila, 1000, Philippines

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Quezon City, 1100, Philippines

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Quezon City, 1113, Philippines

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Bieńkówka, 34-212, Poland

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Bydgoszcz, 85-096, Poland

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Krakow, 31-159, Poland

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Lublin, 20-093, Poland

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Oleśnica, 56-400, Poland

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Ostrów Wielkopolski, 63-400, Poland

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Siemianowice Śląskie, 41-103, Poland

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Wroclaw, 50-445, Poland

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Wroclaw, 51-511, Poland

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Zawadzkie, 47-120, Poland

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Hato Rey, Puerto Rico, 00917, Puerto Rico

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Bratislava, 826 05, Slovakia

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Martin, 036 59, Slovakia

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Vysoké Tatry, 059 81, Slovakia

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Meyerspark, Gauteng, 0184, South Africa

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CapeTown, 7764, South Africa

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Middelburg, 1501, South Africa

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Panorama, 7500, South Africa

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Kharkiv, 61093, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04050, Ukraine

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Zaporizhia, 69063, Ukraine

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GSK Investigational Site

Zaporizhia, 69076, Ukraine

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Related Publications (1)

• 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.

  PMID: 27044326 DERIVED

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; vilanterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 9, 2017
• Results First Posted: April 3, 2015

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

PE (4); PH (4); PR (1); JP (12); ZA (4); SL (3); UA (5); DE (17); US (34); CL (4); GE (4); PL (10); AR (14); ME (4)