24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease

March 7, 2017 updated by: GlaxoSmithKline

A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD

This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

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.

Detailed Description

This is a 24-week, Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study. Eligible subjects will be randomized to GSK573719/GW642444 125/25mcg, GSK573719/GW642444 62.5/25mcg, GSK573719 125mcg, or tiotropium treatment groups in a 1:1:1:1 ratio. Treatments will be administered once-daily in the morning by inhalation using a Novel Dry Powder Inhaler (Novel DPI) and HandiHaler. There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7 to 10 day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169). A follow-up contact for adverse assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit. The total duration of subject participation, including follow-up will be approximately 26 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and study treatment periods. At screening, pre-bronchodilator spirometry testing will be followed by post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/forced vital capacity (FVC) values will be used to determine subject eligibility. To further characterize bronchodilator responsiveness, post-ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry. Spirometry will be conducted at each post-randomization clinic visit. Six hour post-dose serial spirometry will be conducted at Visits 2, 6, and 8. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 9. All subjects will be provided with an electronic diary (eDiary) for completion daily in the morning and the evening throughout the run-in and treatment periods. Subjects will use the eDiary to record peak expiratory flow (PEF) each morning, dyspnea scores using the Shortness of Breath with Daily Activities instrument (SOBDA), daily use of supplemental albuterol/salbutamol as either puffs/day from a metered-dose inhaler (MDI) and/or nebules used per day, and any healthcare contacts related to COPD. Additional assessments of dyspnea will be obtained using the Baseline and Transition Dyspnea Index (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnea at baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI. General health status will be evaluated using the subject-completed EQ-5D questionnaire at Visits 2, 4, 6, and 8. Disease specific health status will be evaluated using the subject-completed St. George's Respiratory Questionnaire (SGRQ) at Visits 2, 4, 6, and 8, and the subject-completed COPD Assessment Test (CAT) at Visits 2, 6, and 8. The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact. Additional safety assessments of vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and chemistry) will be obtained at selected clinic visits.

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.
872

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 3

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
      • Buenos Aires, Argentina, C1424BSF
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1425BEN
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1028AAP
        • GSK Investigational Site
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • GSK Investigational Site
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • GSK Investigational Site
      • Carina Heights, Queensland, Australia, 4152
        • GSK Investigational Site
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
      • Daw Park, South Australia, Australia, 5041
        • GSK Investigational Site
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • GSK Investigational Site
      • Parkville, Victoria, Australia, 3050
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • GSK Investigational Site
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • GSK Investigational Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2V8
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 1H5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5T 3A9
        • GSK Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • GSK Investigational Site
      • St-Romulad, Quebec, Canada, G6W 5M6
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8380453
        • GSK Investigational Site
    • Región De Los Lagos
      • Puerto Montt, Región De Los Lagos, Chile, 5480000
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7500551
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500710
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500800
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7601003
        • GSK Investigational Site
      • Talca, Región Metro De Santiago, Chile, 3460001
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10629
        • GSK Investigational Site
      • Berlin, Germany, 12099
        • GSK Investigational Site
      • Hamburg, Germany, 22335
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Schwetzingen, Baden-Wuerttemberg, Germany, 68723
        • GSK Investigational Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • GSK Investigational Site
    • Brandenburg
      • Oranienburg, Brandenburg, Germany, 16515
        • GSK Investigational Site
      • Ruedersdorf, Brandenburg, Germany, 15562
        • GSK Investigational Site
      • Schwedt, Brandenburg, Germany, 16303
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
        • GSK Investigational Site
      • Kassel, Hessen, Germany, 34121
        • GSK Investigational Site
    • Niedersachsen
      • Wolfenbuettel, Niedersachsen, Germany, 38300
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Dueren, Nordrhein-Westfalen, Germany, 52349
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04207
        • GSK Investigational Site
  • Korea, Republic of
      • Bucheon-si,, Korea, Republic of, 420-767
        • GSK Investigational Site
      • Cheongju, Chungcheongbuk-do, Korea, Republic of, 361-711
        • GSK Investigational Site
      • Daegu, Korea, Republic of, 705-717
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 405-760
        • GSK Investigational Site
      • Kangwon-do, Korea, Republic of, 220-701
        • GSK Investigational Site
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 143-729
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • GSK Investigational Site
      • Seoul, Korea, Republic of
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 130-702
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 100-032
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 130-848
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 156-707
        • GSK Investigational Site
      • Suwon, Kyonggi-do, Korea, Republic of, 443-721
        • GSK Investigational Site
  • Mexico
      • Durango, Mexico, 34080
        • GSK Investigational Site
      • Mexico, Mexico, 14000
        • GSK Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45040
        • GSK Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64020
        • GSK Investigational Site
  • Romania
      • Constanta, Romania, 900002
        • GSK Investigational Site
      • Ploiesti, Romania, 100379
        • GSK Investigational Site
      • Targoviste, Romania, 130086
        • GSK Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • GSK Investigational Site
      • Boksburg North, South Africa, 1459
        • GSK Investigational Site
      • Die Wilgers, South Africa, 0041
        • GSK Investigational Site
      • Durban, South Africa, 4091
        • GSK Investigational Site
      • Gatesville, South Africa, 7764
        • GSK Investigational Site
      • Groenkloof, South Africa, 0181
        • GSK Investigational Site
      • Pretoria, South Africa, 0002
        • GSK Investigational Site
      • Thabazimbi, South Africa, 0380
        • GSK Investigational Site
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • California
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • GSK Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • GSK Investigational Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • GSK Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • GSK Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Elizabeth City, North Carolina, United States, 27909
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • GSK Investigational Site
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • 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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatient
  • signed and dated written informed consent
  • 40 years of age or older
  • male and female subjects
  • COPD diagnosis
  • at least 10 pack-year smoking history
  • post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of less than or equal to 70% predicted normal values
  • score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)

Exclusion Criteria:

  • women who are pregnant or lactating or are planning on becoming pregnant during the study
  • current diagnosis of asthma
  • other respiratory disorders other than COPD
  • other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
  • chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
  • hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
  • hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
  • lung volume reduction surgery within 12 months prior to Visit 1
  • abnormal and clinically significant ECG at Visit 1
  • significantly abnormal finding from laboratory tests at Visit 1
  • unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each visit
  • use of depot corticosteroids within 12 weeks of Visit 1
  • use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1
  • use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1
  • use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
  • initiation or discontinuation of ICS within 30 days of Visit 1
  • use of tiotropium or roflumilast within 14 days of Visit 1
  • use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
  • short-acting oral beta-agonists within 12 hours of Visit 1
  • use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
  • use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
  • use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 4 hours of Visit 1
  • use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
  • long-term oxygen therapy prescribed for >12 hours per day
  • regular use of nebulized short-acting bronchodilators
  • participation in acute phase of pulmonary rehabilitation program
  • known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
  • anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
  • previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination

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 Assignment
  • Masking: Quadruple

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.
Experimental: GSK573719/GW642444 125/25
125/25 mcg once-daily
Drug: GSK573719/GW642444 125/25
125/25 mcg once-daily
Other Names:
  • GSK573719/vilanterol trifenatate
Experimental: GSK573719/GW642444 62.5/25
62.5/25 mcg once-daily
Drug: GSK573719/GW642444 62.5/25
62.5/25 mcg once-daily
Other Names:
  • GSK573719/vilanterol trifenatate
Experimental: GSK573719
125 mcg once-daily
Drug: GSK573719
125 mcg once-daily
Active Comparator: tiotropium bromide
18 mcg once-daily
Drug: tiotropium bromide
18 mcg once-daily

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 Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169
Time Frame: Baseline and Day 169
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.
Baseline and Day 169

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 (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168
Time Frame: Baseline and Day 168
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.
Baseline and Day 168

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24
Time Frame: Baseline and Week 24
The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.
Baseline and Week 24

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.
March 1, 2011

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, 2012

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, 2012

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 15, 2011

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.
March 15, 2011

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.
March 16, 2011

Study Record Updates

Last Update Posted (Actual)

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.
April 4, 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.
March 7, 2017

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.
March 1, 2017

More Information

Terms related to this study

Keywords

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.
  • 113374

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. Dataset Specification
    Information identifier: 113374
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 113374
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 113374
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: 113374
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: 113374
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: 113374
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: 113374
    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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