6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
VESTRI
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
1 other identifier
interventional
6,250
31 countries
527
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Nov 2011
Longer than P75 for phase_4 asthma
527 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2011
CompletedFirst Posted
Study publicly available on registry
October 31, 2011
CompletedStudy Start
First participant enrolled
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2015
CompletedResults Posted
Study results publicly available
October 5, 2016
CompletedAugust 6, 2018
August 1, 2018
4 years
October 27, 2011
May 2, 2016
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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.
From Day 1 up to 6 months
Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
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.
From Day 1 up to 6 months
Secondary Outcomes (6)
Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
From Day 1 up to 6 months
Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period
From Day 1 up to 6 months
Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period
From Day 1 up to 6 months
Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
From Day 1 up to 6 months
Percentage of Rescue-free Days Over the 6-month Study Treatment Period
From Day 1 up to 6 months
- +1 more secondary outcomes
Study Arms (4)
ADVAIR 100/50mcg
EXPERIMENTALfluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
ADVAIR 250/50mcg
EXPERIMENTALfluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
FLOVENT 100mcg
ACTIVE COMPARATORfluticasone propionate (100) twice daily (AM and PM) for 6 months
FLOVENT 250mcg
ACTIVE COMPARATORfluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Interventions
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate (100) twice daily (AM and PM) for 6 months
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Eligibility Criteria
You may qualify if:
- Consent to participate in the study
- Age 4-11 years old
- 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
- Asthma diagnosis for at least 6 months
- Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
- 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.
- History of at least once occurrence of asthma exacerbation within the prior 12 months
- 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)
You may not qualify if:
- History of life-threatening asthma
- Unstable asthma
- Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
- 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.
- Respiratory infection
- Subjects with only exercise-induced asthma
- An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
- Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
- Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
- 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
- Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
- 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
- Severe hypersensitivity to cow's milk proteins
- 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
- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- Parexelcollaborator
Study Sites (530)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Birmingham, Alabama, 35233, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Montgomery, Alabama, 36109, United States
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Scottsboro, Alabama, 35768, United States
GSK Investigational Site
Toney, Alabama, 35773, United States
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Tuscaloosa, Alabama, 35401, United States
GSK Investigational Site
Dothan, Alaska, 36305, United States
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Chandler, Arizona, 85224, United States
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Phoenix, Arizona, 85020, United States
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Scottsdale, Arizona, 85255, United States
GSK Investigational Site
Scottsdale, Arizona, 85288, United States
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Tucson, Arizona, 85724-5073, United States
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Tucson, Arizona, 85741, United States
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Bentonville, Arkansas, 72712, United States
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Little Rock, Arkansas, 72204, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Little Rock, Arkansas, 72209, United States
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Alhambra, California, 91801, United States
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Bakersfield, California, 93301, United States
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Canoga Park, California, 91306, United States
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Dinuba, California, 93618, United States
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Fresno, California, 93703, United States
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Fresno, California, 93720, United States
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Gold River, California, 95670, United States
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Granada Hills, California, 91344, United States
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Harbor City, California, 90710, United States
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Huntington Beach, California, 92647, United States
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Huntington Park, California, 90255, United States
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Long Beach, California, 90807, United States
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Long Beach, California, 90808, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90057, United States
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Napa, California, 94558, United States
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Newport Beach, California, 92660, United States
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Newport Beach, California, 92663, United States
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Oakland, California, 94609, United States
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Orange, California, 92868, United States
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Palmdale, California, 93551, United States
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Paramount, California, 90723, United States
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Riverside, California, 92501, United States
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Rolling Hills Est., California, 920274, United States
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Rolling Hills Estates, California, 90274, United States
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Roseville, California, 95678, United States
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Sacramento, California, 95825, United States
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San Marino, California, 91108, United States
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Santa Monica, California, 90404, United States
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West Covina, California, 91790, United States
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West Sacramento, California, 95691, United States
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Aurora, Colorado, 80045, United States
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Centennial, Colorado, 80112, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80920, United States
GSK Investigational Site
Colorado Springs, Colorado, 80922, United States
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Denver, Colorado, 80206, United States
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Waterbury, Connecticut, 06708, United States
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Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
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Boynton Beach, Florida, 33435, United States
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Cocoa, Florida, 32927, United States
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Coral Gables, Florida, 33134, United States
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Destin, Florida, 32541, United States
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Doral, Florida, 33172, United States
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Gainesville, Florida, 32605, United States
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Gainesville, Florida, 32610, United States
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Hialeah, Florida, 33012, United States
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Melbourne, Florida, 32935, United States
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Miami, Florida, 33126, United States
GSK Investigational Site
Miami, Florida, 33135, United States
GSK Investigational Site
Miami, Florida, 33142, United States
GSK Investigational Site
Miami, Florida, 33144, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Miami, Florida, 33175, United States
GSK Investigational Site
Miami, Florida, 33176, United States
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Miami, Florida, 33184, United States
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Miami Lakes, Florida, 33016, United States
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Naples, Florida, 34102, United States
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New Port Richey, Florida, 34652, United States
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Ocala, Florida, 34471, United States
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Orlando, Florida, 32806, United States
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Orlando, Florida, 32811, United States
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Orlando, Florida, 32822, United States
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Pace, Florida, 32571, United States
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Pensacola, Florida, 32503, United States
GSK Investigational Site
Pensacola, Florida, 32514, United States
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Ponte Vedra Beach, Florida, 32081, United States
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Saint Cloud, Florida, 34769, United States
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St. Petersburg, Florida, 33701, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
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Tampa, Florida, 33606, United States
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Tampa, Florida, 33613, United States
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Wellington, Florida, 33414, United States
GSK Investigational Site
Augusta, Georgia, 30909, United States
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Calhoun, Georgia, 30701, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
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Lilburn, Georgia, 30047, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
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Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Chicago, Illinois, 60616, United States
GSK Investigational Site
Evergreen Park, Illinois, 60805, United States
GSK Investigational Site
Glenview, Illinois, 60025, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
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Shiloh, Illinois, 62269, United States
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Crown Point, Indiana, 46307, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
Indianapolis, Indiana, 46256, United States
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West Des Moines, Iowa, 50265, United States
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Overland Park, Kansas, 66210, United States
GSK Investigational Site
Lexington, Kentucky, 40508, United States
GSK Investigational Site
Lexington, Kentucky, 40509, United States
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Louisville, Kentucky, 40291, United States
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Owensboro, Kentucky, 42301, United States
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Metairie, Louisiana, 70006, United States
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Shreveport, Louisiana, 71106, United States
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Bangor, Maine, 04401, United States
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Largo, Maryland, 20774, United States
GSK Investigational Site
Silver Spring, Maryland, 20910, United States
GSK Investigational Site
White Marsh, Maryland, 21162, United States
GSK Investigational Site
Fall River, Massachusetts, 02720, United States
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Buckley, Michigan, 49620, United States
GSK Investigational Site
Fenton, Michigan, 48430, United States
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Niles, Michigan, 49120, United States
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Stevensville, Michigan, 49127, United States
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Ypsilanti, Michigan, 48197, United States
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Plymouth, Minnesota, 55441, United States
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Port Gibson, Mississippi, 39150, United States
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Kansas City, Missouri, 64108, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
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Kansas City, Missouri, 64138, United States
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Warrensburg, Missouri, 64093, United States
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Billings, Montana, 59101, United States
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Great Falls, Montana, 59405, United States
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Missoula, Montana, 59808, United States
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Bellevue, Nebraska, 68005, United States
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Bellevue, Nebraska, 68123-4303, United States
GSK Investigational Site
Lincoln, Nebraska, 68516, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Las Vegas, Nevada, 89107, United States
GSK Investigational Site
Brick, New Jersey, 8724, United States
GSK Investigational Site
Edison, New Jersey, 08817, United States
GSK Investigational Site
Edison, New Jersey, 08820, United States
GSK Investigational Site
Livingston, New Jersey, 07039, United States
GSK Investigational Site
Marlton, New Jersey, 08053, United States
GSK Investigational Site
Northfield, New Jersey, 8225, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Somerville, New Jersey, 8876, United States
GSK Investigational Site
Verona, New Jersey, 07044, United States
GSK Investigational Site
Albuquerque, New Mexico, 87109, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131, United States
GSK Investigational Site
Astoria, New York, 11103, United States
GSK Investigational Site
Great Neck, New York, 11023, United States
GSK Investigational Site
Johnson City, New York, 13790, United States
GSK Investigational Site
Newburgh, New York, 12550, United States
GSK Investigational Site
North Syracuse, New York, 13212, United States
GSK Investigational Site
Staten Island, New York, 10304, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Utica, New York, 13502, United States
GSK Investigational Site
Westfield, New York, 14787, United States
GSK Investigational Site
Asheboro, North Carolina, 27203, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Clyde, North Carolina, 28721, United States
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High Point, North Carolina, 27262, United States
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Shelby, North Carolina, 28152, United States
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Fargo, North Dakota, 58104, United States
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Akron, Ohio, 44308-1062, United States
GSK Investigational Site
Beavercreek, Ohio, 45431, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Centerville, Ohio, 45458, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cleveland, Ohio, 44130, United States
GSK Investigational Site
Dayton, Ohio, 45406, United States
GSK Investigational Site
Dayton, Ohio, 45432, United States
GSK Investigational Site
Marion, Ohio, 43302, United States
GSK Investigational Site
Shaker Heights, Ohio, 44120, United States
GSK Investigational Site
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Toledo, Ohio, 43606, United States
GSK Investigational Site
Toledo, Ohio, 43617, United States
GSK Investigational Site
Wheeling, Ohio, 26003, United States
GSK Investigational Site
Zanesville, Ohio, 43701, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73131, United States
GSK Investigational Site
Ashland, Oregon, 97520, United States
GSK Investigational Site
Gresham, Oregon, 97030, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Belle Vernon, Pennsylvania, 15012, United States
GSK Investigational Site
Blue Bell, Pennsylvania, 19422, United States
GSK Investigational Site
Johnstown, Pennsylvania, 15904, United States
GSK Investigational Site
Latrobe, Pennsylvania, 15650, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
Shippensburg, Pennsylvania, 17257, United States
GSK Investigational Site
Lincoln, Rhode Island, 2865, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Columbia, South Carolina, 29203, United States
GSK Investigational Site
Fort Mill, South Carolina, 29707, United States
GSK Investigational Site
Greenville, South Carolina, 29607, United States
GSK Investigational Site
Chattanooga, Tennessee, 37411, United States
GSK Investigational Site
Chattanooga, Tennessee, 37421, United States
GSK Investigational Site
Germantown, Tennessee, 38138, United States
GSK Investigational Site
McKenzie, Tennessee, 38201, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Nashville, Tennessee, 37214, United States
GSK Investigational Site
Shelbyville, Tennessee, 37160, United States
GSK Investigational Site
Allen, Texas, 75013, United States
GSK Investigational Site
Arlington, Texas, 76018, United States
GSK Investigational Site
Austin, Texas, 78759-8950, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Dallas, Texas, 75225, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Dickinson, Texas, 77539, United States
GSK Investigational Site
Duncanville, Texas, 75116, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
Gun Barrel City, Texas, 75156, United States
GSK Investigational Site
Houston, Texas, 77036, United States
GSK Investigational Site
Houston, Texas, 77055, United States
GSK Investigational Site
Houston, Texas, 77077, United States
GSK Investigational Site
Irving, Texas, 75039, United States
GSK Investigational Site
Katy, Texas, 77450, United States
GSK Investigational Site
Killeen, Texas, 76542, United States
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Kingwood, Texas, 77339, United States
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Lewisville, Texas, 75067, United States
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Live Oak, Texas, 78233, United States
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Lufkin, Texas, 75904, United States
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San Antonio, Texas, 78207, United States
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San Antonio, Texas, 78224, United States
GSK Investigational Site
San Antonio, Texas, 78228, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78251, United States
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San Antonio, Texas, 78299, United States
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Sealy, Texas, 77474, United States
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Sugar Land, Texas, 77478, United States
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Sugar Land, Texas, 77479, United States
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Tomball, Texas, 77375, United States
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Tyler, Texas, 75708, United States
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Waco, Texas, 76710, United States
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Waco, Texas, 76712, United States
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Waxahachie, Texas, 75165, United States
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Clinton, Utah, 84015, United States
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Draper, Utah, 84020, United States
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Layton, Utah, 84041, United States
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Murray, Utah, 84107, United States
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Woods Cross, Utah, 84087, United States
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Charlottesville, Virginia, 22902, United States
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Hampton, Virginia, 23666, United States
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Midlothian, Virginia, 23113, United States
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Midlothian, Virginia, 23114, United States
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Norfolk, Virginia, 23507, United States
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Richmond, Virginia, 23223, United States
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Richmond, Virginia, 23226, United States
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Richmond, Virginia, 23235, United States
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Virginia Beach, Virginia, 23454, United States
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Bellingham, Washington, 98225, United States
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Puyallup, Washington, 98371, United States
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Wenatchee, Washington, 98801, United States
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Greenfield, Wisconsin, 53228, United States
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La Crosse, Wisconsin, 54601, United States
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Madison, Wisconsin, 53792-9988, United States
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Milwaukee, Wisconsin, 53226, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1122AAK, 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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Concepción del Uruguay, Entre Ríos Province, 3260, Argentina
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Paraná, Entre Ríos Province, E3100BHK, Argentina
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Buenos Aires, 1425, Argentina
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Buenos Aires, 7000, Argentina
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1425BEN, Argentina
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Capital Federal, C1270AAN, Argentina
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Lanús, B1824KAJ, Argentina
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San Miguel de Tucumán, T4000IFL, Argentina
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Westmead, New South Wales, 2145, Australia
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Auchenflower, Queensland, 4066, Australia
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Subiaco, Western Australia, 6008, Australia
GSK Investigational Site
Parkville, 3052, Australia
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Randwick, 2031, Australia
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Bregenz, A-6900, Austria
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Feldkirch, 6800, Austria
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Vienna, 1090, Austria
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Antwerp, 2018, Belgium
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Brussels, 1090, Belgium
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Gembloux, 5030, Belgium
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Leuven, 3000, Belgium
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Natoye, 5360, Belgium
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Blagoevgrad, 2700, Bulgaria
GSK Investigational Site
Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7000, Bulgaria
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Rousse, 7002, Bulgaria
GSK Investigational Site
Sevlievo, 5400, Bulgaria
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Sofia, 1431, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9000, Bulgaria
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Varna, 9010, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vidin, 3700, Bulgaria
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Brampton, Ontario, L6T3J1, Canada
GSK Investigational Site
Burlington, Ontario, L7L 0B7, Canada
GSK Investigational Site
Oshawa, Ontario, L1H 7K4, Canada
GSK Investigational Site
Toronto, Ontario, M5T 3A9, Canada
GSK Investigational Site
Windsor, Ontario, N8X 2G1, Canada
GSK Investigational Site
Santiago, 7560994, Chile
GSK Investigational Site
Valdivia, 5090146, Chile
GSK Investigational Site
Viña del Mar, 2570017, Chile
GSK Investigational Site
Medellín, Colombia
GSK Investigational Site
Čakovec, 40000, Croatia
GSK Investigational Site
Dubrovnik, 20000, Croatia
GSK Investigational Site
Jastrebarsko, 10450, Croatia
GSK Investigational Site
Rijeka, 51000, Croatia
GSK Investigational Site
Split, 21000, Croatia
GSK Investigational Site
Zagreb, 10000, Croatia
GSK Investigational Site
Brno, 615 00, Czechia
GSK Investigational Site
Brno, 625 00, Czechia
GSK Investigational Site
Česká Lípa, 470 01, Czechia
GSK Investigational Site
Olomouc, 775 20, Czechia
GSK Investigational Site
Prague, 147 00, Czechia
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Fürth, Bavaria, 90762, Germany
GSK Investigational Site
Höchstadt an der Aisch, Bavaria, 91315, Germany
GSK Investigational Site
Weißenhorn, Bavaria, 89264, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60590, Germany
GSK Investigational Site
Bad Pyrmont, Lower Saxony, 31812, Germany
GSK Investigational Site
Bad Lippspringe, North Rhine-Westphalia, 33175, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791, Germany
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756, Germany
GSK Investigational Site
Hagen, North Rhine-Westphalia, 58089, Germany
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41469, Germany
GSK Investigational Site
Telgte, North Rhine-Westphalia, 48291, Germany
GSK Investigational Site
Teuchern, Saxony-Anhalt, 6682, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Reinfeld, Schleswig-Holstein, 23858, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 13353, Germany
GSK Investigational Site
Baja, 6500, Hungary
GSK Investigational Site
Budapest, 1037, Hungary
GSK Investigational Site
Budapest, 1089, Hungary
GSK Investigational Site
Budapest, 1146, Hungary
GSK Investigational Site
Miskolc, 3501, Hungary
GSK Investigational Site
Nagykanizsa, 08800, Hungary
GSK Investigational Site
Ráckeve, 2300, Hungary
GSK Investigational Site
Szekszárd, 7100, Hungary
GSK Investigational Site
Törökbálint, 2045, Hungary
GSK Investigational Site
Rome, Lazio, 00157, Italy
GSK Investigational Site
Milan, Lombardy, 20129, Italy
GSK Investigational Site
Brescia, 25123, Italy
GSK Investigational Site
Messina, 98123, Italy
GSK Investigational Site
Milan, 20142, Italy
GSK Investigational Site
Palermo, 90146, Italy
GSK Investigational Site
Roma, 00168, Italy
GSK Investigational Site
Sesto San Giovanni, 20099, Italy
GSK Investigational Site
Riga, 1011, Latvia
GSK Investigational Site
Riga, 1063, Latvia
GSK Investigational Site
Riga, LV 1003, Latvia
GSK Investigational Site
Riga, LV 1004, Latvia
GSK Investigational Site
Tukums, 3101, Latvia
GSK Investigational Site
Kaunas, LT-49449, Lithuania
GSK Investigational Site
Kaunas, LT-50009, Lithuania
GSK Investigational Site
Utena, LT-28151, Lithuania
GSK Investigational Site
Vilnius, LT-04338, Lithuania
GSK Investigational Site
Vilnius, LT-08406, Lithuania
GSK Investigational Site
Ipoh, 32040, Malaysia
GSK Investigational Site
Kuala Lumpur, 59100, Malaysia
GSK Investigational Site
Kuching, 93586, Malaysia
GSK Investigational Site
Seremban, Negeri Sembilan, 70300, Malaysia
GSK Investigational Site
Sibu, 96000, Malaysia
GSK Investigational Site
Sungai Buloh, 47000, Malaysia
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64710, Mexico
GSK Investigational Site
Chihuahua City, 31020, Mexico
GSK Investigational Site
Huixquilucan, 52763, Mexico
GSK Investigational Site
Monterrey, 64718, Mexico
GSK Investigational Site
Miraflores, Lima region, 18, Peru
GSK Investigational Site
San Martín de Porres, Lima region, Lima 31, Peru
GSK Investigational Site
Santiago de Surco, Lima region, Lima 33, Peru
GSK Investigational Site
Lima, Lima 18, Peru
GSK Investigational Site
Lima, Lima 1, Peru
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
San Borja, L36, Peru
GSK Investigational Site
Dasmariñas, Cavite, 4114, Philippines
GSK Investigational Site
Davao City, 8000, Philippines
GSK Investigational Site
Pulilan, 3005, Philippines
GSK Investigational Site
Quezon City, 1100, Philippines
GSK Investigational Site
Quezon City, 1108, Philippines
GSK Investigational Site
Bialystok, 15-430, Poland
GSK Investigational Site
Bialystok, Poland
GSK Investigational Site
Cieszyn, 43-400, Poland
GSK Investigational Site
Dębica, 39 - 200, Poland
GSK Investigational Site
Gdansk, 80-308, Poland
GSK Investigational Site
Gdansk, 80-433, Poland
GSK Investigational Site
Gdansk, 80-462, Poland
GSK Investigational Site
Jelenia Góra, 58-500, Poland
GSK Investigational Site
Karpacz, 58-540, Poland
GSK Investigational Site
Koszalin, 75-729, Poland
GSK Investigational Site
Krakow, 31-023, Poland
GSK Investigational Site
Krakow, 31-503, Poland
GSK Investigational Site
Lodz, 90-553, Poland
GSK Investigational Site
Lodz, 93-513, Poland
GSK Investigational Site
Lubin, 59-300, Poland
GSK Investigational Site
Lublin, 20-093, Poland
GSK Investigational Site
Lublin, 20-552, Poland
GSK Investigational Site
Poznan, 60-214, Poland
GSK Investigational Site
Rzeszów, 35-241, Poland
GSK Investigational Site
Sandomierz, 27-600, Poland
GSK Investigational Site
Skarżysko-Kamienna, 26-110, Poland
GSK Investigational Site
Skierniewice, 96-100, Poland
GSK Investigational Site
Szczecin, 70-382, Poland
GSK Investigational Site
Szczecin, 70-780, Poland
GSK Investigational Site
Tarnów, 33-100, Poland
GSK Investigational Site
Warsaw, 01-157, Poland
GSK Investigational Site
Wroclaw, 50-445, Poland
GSK Investigational Site
Wroclaw, 53-301, Poland
GSK Investigational Site
Zabrze, 41 - 800, Poland
GSK Investigational Site
Zabrze, 41-800, Poland
GSK Investigational Site
Bucharest, 20395, Romania
GSK Investigational Site
Sibiu, 550166, Romania
GSK Investigational Site
Moscow, 119435, Russia
GSK Investigational Site
Moscow, 119991, Russia
GSK Investigational Site
Moscow, 125412, Russia
GSK Investigational Site
Nizhny Novgorod, 603005, Russia
GSK Investigational Site
Novosibirsk, 630099, Russia
GSK Investigational Site
Saint Petersburg, 192212, Russia
GSK Investigational Site
Saint Petersburg, 194100, Russia
GSK Investigational Site
Saint Petersburg, 196084, Russia
GSK Investigational Site
Saint Petersburg, 196657, Russia
GSK Investigational Site
Saratov, 410028, Russia
GSK Investigational Site
St'Petersburg, 191144, Russia
GSK Investigational Site
Tomsk, 634 050, Russia
GSK Investigational Site
Voronezh, 394036, Russia
GSK Investigational Site
Yaroslavl, 150003, Russia
GSK Investigational Site
Belgrade, 11000, Serbia
GSK Investigational Site
Čačak, 32000, Serbia
GSK Investigational Site
Niš, 18000, Serbia
GSK Investigational Site
Novi Sad, 21 000, Serbia
GSK Investigational Site
Užice, 31000, Serbia
GSK Investigational Site
Martin, 036 59, Slovakia
GSK Investigational Site
Nitra, 949 01, Slovakia
GSK Investigational Site
Trnava, 917 01, Slovakia
GSK Investigational Site
Welkom, Free State, 9460, South Africa
GSK Investigational Site
Benoni, Gauteng, 1501, South Africa
GSK Investigational Site
Krugersdorp, Gauteng, 1752, South Africa
GSK Investigational Site
Pretoria, Gauteng, 0132, South Africa
GSK Investigational Site
Benoni, 1501, South Africa
GSK Investigational Site
Cape Town, 7441, South Africa
GSK Investigational Site
Cape Town, 7500, South Africa
GSK Investigational Site
Cape Town, 7572, South Africa
GSK Investigational Site
Cape Town, 7700, South Africa
GSK Investigational Site
Claremont, 7708, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
Middelburg, 1501, South Africa
GSK Investigational Site
Paarl, 7646, South Africa
GSK Investigational Site
Pretoria, 0001, South Africa
GSK Investigational Site
Pretoria, 0002, South Africa
GSK Investigational Site
Thabazimbi, 0380, South Africa
GSK Investigational Site
Cheongju-si, 361-711, South Korea
GSK Investigational Site
Gyeonggi-do, 463-712, South Korea
GSK Investigational Site
Gyeonggi-do, 471-020, South Korea
GSK Investigational Site
Gyeonggi-do, 480-717, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Pusan, 612030, South Korea
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, 130-702, South Korea
GSK Investigational Site
Seoul, 137-701, South Korea
GSK Investigational Site
Seoul, 143-729, South Korea
GSK Investigational Site
Barcelona, 08022, Spain
GSK Investigational Site
Burgos, 09005, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223, Spain
GSK Investigational Site
Sabadell (Barcelona), 8208, Spain
GSK Investigational Site
Valencia, 46026, Spain
GSK Investigational Site
Changhua, 500, Taiwan
GSK Investigational Site
Kaohsiung City, 807, Taiwan
GSK Investigational Site
Kaohsiung City, 813, Taiwan
GSK Investigational Site
Taichung, 402, Taiwan
GSK Investigational Site
Taichung, 40447, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 11031, Taiwan
GSK Investigational Site
Taoyuan District, 333, Taiwan
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Bangkoknoi, 10700, Thailand
GSK Investigational Site
Khon Kaen, 40002, Thailand
GSK Investigational Site
Pathum Thani, 12120, Thailand
GSK Investigational Site
Phitsanulok, 65000, Thailand
GSK Investigational Site
Ratchatewi, 10400, Thailand
GSK Investigational Site
Dnipropetrovsk, 49100, Ukraine
GSK Investigational Site
Dnipropetrovsk, 49101, Ukraine
GSK Investigational Site
Kharkiv, 61050, Ukraine
GSK Investigational Site
Kharkiv, 61093, Ukraine
GSK Investigational Site
Kryvyi Rih, 50082, Ukraine
GSK Investigational Site
Kyiv, 4050, Ukraine
GSK Investigational Site
Kyiv, Ukraine
GSK Investigational Site
Lviv, 79059, Ukraine
GSK Investigational Site
Odesa, 65031, Ukraine
GSK Investigational Site
Odesa, 65038, Ukraine
GSK Investigational Site
Poltava, 36011, Ukraine
GSK Investigational Site
Simferopol, 95006, Ukraine
GSK Investigational Site
Sumy, 40031, Ukraine
GSK Investigational Site
Uzhhorod, 88009, Ukraine
GSK Investigational Site
Zaporizhia, 69063, Ukraine
GSK Investigational Site
Chesterfield, Derbyshire, S40 4TF, United Kingdom
GSK Investigational Site
Cardiff, Glamorgan, CF5 4AE, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, Northumberland, NE1 4LP, United Kingdom
GSK Investigational Site
Bath, Somerset, BA2 1NH, United Kingdom
GSK Investigational Site
Brighton, Sussex East, BN2 5BE, United Kingdom
GSK Investigational Site
Atherstone, Warwickshire, CV9 1EU, United Kingdom
GSK Investigational Site
Barry, CF63 4AR, United Kingdom
GSK Investigational Site
Bexhill-on-Sea, TN40 1JJ, United Kingdom
GSK Investigational Site
Doncaster, DN9 2HY, United Kingdom
GSK Investigational Site
Glasgow, G3 8SJ, United Kingdom
GSK Investigational Site
Kent, CT5 3QU, United Kingdom
GSK Investigational Site
Leicester, LE1 5WW, United Kingdom
GSK Investigational Site
Macclesfield, SK10 3BL, United Kingdom
GSK Investigational Site
Merseyside, CH41 0DD, United Kingdom
GSK Investigational Site
Penzance, TK19 7HX, United Kingdom
GSK Investigational Site
Peterborough, PE8 6PL, United Kingdom
GSK Investigational Site
Stockton-on-Tees, TS19 8PE, United Kingdom
GSK Investigational Site
Stoke-on-Trent, ST4 6QG, United Kingdom
GSK Investigational Site
Surrey, RH1 5RH, United Kingdom
Related Publications (2)
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.
PMID: 32966707DERIVEDStempel 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.
PMID: 27579634DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2011
First Posted
October 31, 2011
Study Start
November 17, 2011
Primary Completion
November 1, 2015
Study Completion
November 3, 2015
Last Updated
August 6, 2018
Results First Posted
October 5, 2016
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.