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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01462344
Registration number
NCT01462344
Ethics application status
Date submitted
27/10/2011
Date registered
31/10/2011
Titles & IDs
Public title
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
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Scientific title
A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
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Secondary ID [1]
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115358
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Universal Trial Number (UTN)
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Trial acronym
VESTRI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ADVAIR 100/50mcg
Treatment: Drugs - ADVAIR 250/50mcg
Treatment: Drugs - FLOVENT 100mcg
Treatment: Drugs - FLOVENT 250mcg
Experimental: ADVAIR 100/50mcg - fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
Experimental: ADVAIR 250/50mcg - fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Active comparator: FLOVENT 100mcg - fluticasone propionate (100) twice daily (AM and PM) for 6 months
Active comparator: FLOVENT 250mcg - fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Treatment: Drugs: ADVAIR 100/50mcg
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
Treatment: Drugs: ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Treatment: Drugs: FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months
Treatment: Drugs: FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
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Assessment method [1]
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Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a \>=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.
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Timepoint [1]
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From Day 1 up to 6 months
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Primary outcome [2]
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Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
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Assessment method [2]
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Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.
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Timepoint [2]
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From Day 1 up to 6 months
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Secondary outcome [1]
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Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
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Assessment method [1]
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Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.
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Timepoint [1]
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From Day 1 up to 6 months
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Secondary outcome [2]
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Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period
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Assessment method [2]
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Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.
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Timepoint [2]
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From Day 1 up to 6 months
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Secondary outcome [3]
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Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period
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Assessment method [3]
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Hospitalization is defined as a \>=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.
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Timepoint [3]
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From Day 1 up to 6 months
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Secondary outcome [4]
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Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
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Assessment method [4]
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An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.
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Timepoint [4]
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From Day 1 up to 6 months
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Secondary outcome [5]
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Percentage of Rescue-free Days Over the 6-month Study Treatment Period
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Assessment method [5]
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Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
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Timepoint [5]
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From Day 1 up to 6 months
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Secondary outcome [6]
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Percentage of Asthma Control Days Over the 6-month Study Treatment Period
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Assessment method [6]
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An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was \<=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
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Timepoint [6]
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From Day 1 up to 6 months
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Eligibility
Key inclusion criteria
1. Consent to participate in the study
2. Age 4-11 years old
3. Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation
4. Asthma diagnosis for at least 6 months
5. Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
6. A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.
7. History of at least once occurrence of asthma exacerbation within the prior 12 months
8. Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)
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Minimum age
4
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Maximum age
11
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of life-threatening asthma
2. Unstable asthma
3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
5. Respiratory infection
6. Subjects with only exercise-induced asthma
7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
9. Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
10. Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements
11. Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
12. Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication
13. Severe hypersensitivity to cow's milk proteins
14. Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics
15. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
16. Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
17. A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/11/2015
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Sample size
Target
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Accrual to date
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Final
6250
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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GSK Investigational Site - Westmead
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Recruitment hospital [2]
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GSK Investigational Site - Auchenflower
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GSK Investigational Site - Subiaco
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GSK Investigational Site - Parkville
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Recruitment hospital [5]
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GSK Investigational Site - Randwick
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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6008 - Subiaco
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3052 - Parkville
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Recruitment postcode(s) [5]
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2031 - Randwick
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Recruitment outside Australia
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Other collaborator category [1]
0
0
Commercial sector/industry
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Parexel
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Ethics approval
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Summary
Brief summary
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
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Trial website
https://clinicaltrials.gov/study/NCT01462344
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Trial related presentations / publications
Lee LA, Pedersen S, Pascoe SJ, Szefler SJ, Lenney W. No dose effect observed with chronic fluticasone propionate on growth velocity in children. Pediatr Allergy Immunol. 2021 Feb;32(2):377-381. doi: 10.1111/pai.13378. Epub 2020 Oct 26. No abstract available. Stempel DA, Szefler SJ, Pedersen S, Zeiger RS, Yeakey AM, Lee LA, Liu AH, Mitchell H, Kral KM, Raphiou IH, Prillaman BA, Buaron KS, Yun Kirby S, Pascoe SJ; VESTRI Investigators. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. N Engl J Med. 2016 Sep 1;375(9):840-9. doi: 10.1056/NEJMoa1606356.
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Public notes
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Contacts
Principal investigator
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0
GSK Clinical Trials
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0
GlaxoSmithKline
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0
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0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01462344