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

November 18, 2016 updated by: GlaxoSmithKline

A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
463

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Berazategui, Argentina, 1886
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1425BEN
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
      • Rosario, Argentina, S2000BRH
        • GSK Investigational Site
      • Salta, Argentina, A4400ERH
        • GSK Investigational Site
      • Tucuman, Argentina, 4000
        • GSK Investigational Site
    • Buenos Aires
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO
        • GSK Investigational Site
      • Florencio Varela, Buenos Aires, Argentina, 1888
        • GSK Investigational Site
      • La Plata, Buenos Aires, Argentina, 1900
        • GSK Investigational Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • GSK Investigational Site
      • Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DBS
        • GSK Investigational Site
      • Rosario, Santa Fe, Argentina, S2000JKR
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8380453
        • GSK Investigational Site
      • Viña del Mar, Chile, 2520594
        • GSK Investigational Site
    • Región Metro De Santiago
      • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7520349
        • GSK Investigational Site
  • Georgia
      • Tbilisi, Georgia, 0159
        • GSK Investigational Site
      • Tbilisi, Georgia, 0160
        • GSK Investigational Site
      • Tbilisi, Georgia, 0186
        • GSK Investigational Site
      • Tbilisi, Georgia, 0119
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10785
        • GSK Investigational Site
      • Hamburg, Germany, 22415
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68163
        • GSK Investigational Site
    • Bayern
      • Rosenheim, Bayern, Germany, 83026
        • GSK Investigational Site
    • Hessen
      • Baunatal-Grossenritte, Hessen, Germany, 34225
        • GSK Investigational Site
      • Frankfurt am Main, Hessen, Germany, 60596
        • GSK Investigational Site
      • Neu isenburg, Hessen, Germany, 63263
        • GSK Investigational Site
    • Niedersachsen
      • Wolfenbuettel, Niedersachsen, Germany, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • GSK Investigational Site
      • Hamm, Nordrhein-Westfalen, Germany, 59063
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
        • GSK Investigational Site
      • Wesel, Nordrhein-Westfalen, Germany, 46483
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04178
        • GSK Investigational Site
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany, 21502
        • GSK Investigational Site
    • Thueringen
      • Neuhaus am Rennweg, Thueringen, Germany, 98724
        • GSK Investigational Site
  • Japan
      • Chiba, Japan, 260-0001
        • GSK Investigational Site
      • Chiba, Japan, 273-0035
        • GSK Investigational Site
      • Fukuoka, Japan, 811-1394
        • GSK Investigational Site
      • Hiroshima, Japan, 720-8520
        • GSK Investigational Site
      • Hokkaido, Japan, 006-0831
        • GSK Investigational Site
      • Hokkaido, Japan, 064-0821
        • GSK Investigational Site
      • Hyogo, Japan, 653-0021
        • GSK Investigational Site
      • Kagawa, Japan, 762-0031
        • GSK Investigational Site
      • Tokyo, Japan, 154-0017
        • GSK Investigational Site
      • Tokyo, Japan, 157-0066
        • GSK Investigational Site
      • Tokyo, Japan, 158-0097
        • GSK Investigational Site
      • Wakayama, Japan, 646-8558
        • GSK Investigational Site
  • Mexico
      • Mexico city, Mexico, 04530
        • GSK Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45040
        • GSK Investigational Site
    • Puebla
      • Puebla, Pue, Puebla, Mexico, 72000
        • GSK Investigational Site
    • Tabasco
      • Villahermosa, Tabasco, Mexico, 86100
        • GSK Investigational Site
  • Peru
      • Lima, Peru, Lima 1
        • GSK Investigational Site
      • Lima, Peru, Lima 27
        • GSK Investigational Site
    • Lima
      • Lima 27, Lima, Peru, Lima 27
        • GSK Investigational Site
      • San Miguel, Lima, Peru, Lima 32
        • GSK Investigational Site
      • Santiago de Surco, Lima, Peru, Lima 33
        • GSK Investigational Site
  • Philippines
      • Cebu City, Philippines, 6000
        • GSK Investigational Site
      • Manila, Philippines, 1000
        • GSK Investigational Site
      • Quezon City, Philippines, 1113
        • GSK Investigational Site
      • Quezon City, Philippines, 1100
        • GSK Investigational Site
  • Poland
      • Bienkowka, Poland, 34-212
        • GSK Investigational Site
      • Bydgoszcz, Poland, 85-096
        • GSK Investigational Site
      • Krakow, Poland, 31-159
        • GSK Investigational Site
      • Lublin, Poland, 20-093
        • GSK Investigational Site
      • Olesnica, Poland, 56-400
        • GSK Investigational Site
      • Ostrow Wielkopolski, Poland, 63-400
        • GSK Investigational Site
      • Siemianowice Slaskie, Poland, 41-103
        • GSK Investigational Site
      • Wroclaw, Poland, 50-445
        • GSK Investigational Site
      • Wroclaw, Poland, 51-511
        • GSK Investigational Site
      • Zawadzkie, Poland, 47-120
        • GSK Investigational Site
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 05
        • GSK Investigational Site
      • Martin, Slovakia, 036 59
        • GSK Investigational Site
      • Vysoke Tatry, Slovakia, 059 81
        • GSK Investigational Site
  • South Africa
      • CapeTown, South Africa, 7764
        • GSK Investigational Site
      • Middelburg, South Africa, 1501
        • GSK Investigational Site
      • Panorama, South Africa, 7500
        • GSK Investigational Site
    • Gauteng
      • Meyerspark, Gauteng, South Africa, 0184
        • GSK Investigational Site
  • Ukraine
      • Kharkiv, Ukraine, 61093
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 04050
        • GSK Investigational Site
      • Zaporizhia, Ukraine, 69063
        • GSK Investigational Site
      • Zaporizhia, Ukraine, 69076
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • Long Beach, California, United States, 90808
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Rolling Hills Estates, California, United States, 90274
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • GSK Investigational Site
      • Miami, Florida, United States, 33173
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31406
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • GSK Investigational Site
      • Shiloh, Illinois, United States, 62269
        • GSK Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • GSK Investigational Site
    • Kentucky
      • Nicholasville, Kentucky, United States, 40356
        • GSK Investigational Site
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68107
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45414
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • GSK Investigational Site
      • Orangeburg, South Carolina, United States, 29118
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78750
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Spring, Texas, United States, 77379
        • GSK Investigational Site
      • Waco, Texas, United States, 76712
        • GSK Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Arm 1
Vilanterol 25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Vilanterol
subjects will recieve 4 weeks via NDPI during treament period
ACTIVE_COMPARATOR: Arm 2
Vilanterol 12.5mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Vilanterol
subjects will recieve 4 weeks via NDPI during treament period
ACTIVE_COMPARATOR: Arm 3
Vilanterol 6.25mcg inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Vilanterol
subjects will recieve 4 weeks via NDPI during treament period
PLACEBO_COMPARATOR: Arm 4
Placebo inhalation powder inhaled once daily in the PM via the new powder inhaler
Drug: Fluticasone propionate 100mcg
all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
Drug: Placebo
Placebo inhalation powder during treatment period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline; Week 1 up to Week 4
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline; Week 4
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline in trough FEV1 at the end of the 4-week Treatment Period was defined using the pre-dose FEV1 measurement taken at the Week 4 clinic visit. Change from Baseline was calculated as the Week 4 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Baseline; Week 4
Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period
Time Frame: Baseline; Week 1 up to Week 4
The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 4-week Treatment Period minus the value at Baseline. The Baseline value is defined as the value at Visit 3 (randomization). Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
Baseline; Week 1 up to Week 4
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period
Time Frame: Baseline; Week 1 up to Week 4
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 morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
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)
Time Frame: Baseline; Week 4
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. Change from Baseline is calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Baseline; Week 4
Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)
Time Frame: Baseline; Week 4
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 morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Baseline; Week 4
Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period
Time Frame: Baseline; Week 1 up to Week 4
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 4-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.
Baseline; Week 1 up to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 106853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 106853
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 106853
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 106853
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 106853
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 106853
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: 106853
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: 106853
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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