AzTrials
AzTrials

AsthmaPhase 4VESTRINCT01462344

6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old

A Phase 4 study testing ADVAIR 100/50mcg, ADVAIR 250/50mcg and FLOVENT 100mcg in people with Asthma, run by GlaxoSmithKline at 530 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Asthma
What is being tested?
ADVAIR 100/50mcg, ADVAIR 250/50mcg and FLOVENT 100mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,250 participants
Where
530 sitesin 32 countries
Study dates
17 Nov 2011to 3 Nov 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 17Show fewer
  • 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)
  • Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • 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.

Trial locations and contacts

530 sites in 32 countries.

530 sites in 32 countries

United States267 sites

  • GSK Investigational Site

    Akron, Ohio, 44308-1062

  • GSK Investigational Site

    Albuquerque, New Mexico, 87109

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Alhambra, California, 91801

  • GSK Investigational Site

    Allen, Texas, 75013

  • GSK Investigational Site

    Arlington, Texas, 76018

  • GSK Investigational Site

    Asheboro, North Carolina, 27203

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Ashland, Oregon, 97520

  • GSK Investigational Site

    Astoria, New York, 11103

  • GSK Investigational Site

    Augusta, Georgia, 30909

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Austin, Texas, 78759-8950

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Bangor, Maine, 04401

  • GSK Investigational Site

    Beavercreek, Ohio, 45431

  • GSK Investigational Site

    Belle Vernon, Pennsylvania, 15012

  • GSK Investigational Site

    Bellevue, Nebraska, 68005

  • GSK Investigational Site

    Bellevue, Nebraska, 68123-4303

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Bentonville, Arkansas, 72712

  • GSK Investigational Site

    Billings, Montana, 59101

  • GSK Investigational Site

    Birmingham, Alabama, 35209

  • GSK Investigational Site

    Birmingham, Alabama, 35233

  • GSK Investigational Site

    Blue Bell, Pennsylvania, 19422

  • GSK Investigational Site

    Boynton Beach, Florida, 33435

  • GSK Investigational Site

    Brick, New Jersey, 8724

  • GSK Investigational Site

    Buckley, Michigan, 49620

  • GSK Investigational Site

    Calhoun, Georgia, 30701

  • GSK Investigational Site

    Canoga Park, California, 91306

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Centerville, Ohio, 45458

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Charlottesville, Virginia, 22902

  • GSK Investigational Site

    Chattanooga, Tennessee, 37411

  • GSK Investigational Site

    Chattanooga, Tennessee, 37421

  • GSK Investigational Site

    Chicago, Illinois, 60616

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Cleveland, Ohio, 44130

  • GSK Investigational Site

    Clinton, Utah, 84015

  • GSK Investigational Site

    Clyde, North Carolina, 28721

  • GSK Investigational Site

    Cocoa, Florida, 32927

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Colorado Springs, Colorado, 80920

  • GSK Investigational Site

    Colorado Springs, Colorado, 80922

  • GSK Investigational Site

    Columbia, South Carolina, 29203

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Corsicana, Texas, 75110

  • GSK Investigational Site

    Crown Point, Indiana, 46307

  • GSK Investigational Site

    Dallas, Texas, 75225

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    Dayton, Ohio, 45432

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Destin, Florida, 32541

  • GSK Investigational Site

    Dickinson, Texas, 77539

  • GSK Investigational Site

    Dinuba, California, 93618

  • GSK Investigational Site

    Doral, Florida, 33172

  • GSK Investigational Site

    Dothan, Alaska, 36305

  • GSK Investigational Site

    Draper, Utah, 84020

  • GSK Investigational Site

    Duncanville, Texas, 75116

  • GSK Investigational Site

    Edison, New Jersey, 08817

  • GSK Investigational Site

    Edison, New Jersey, 08820

  • GSK Investigational Site

    El Paso, Texas, 79925

  • GSK Investigational Site

    Evansville, Indiana, 47713

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Evergreen Park, Illinois, 60805

  • GSK Investigational Site

    Fall River, Massachusetts, 02720

  • GSK Investigational Site

    Fargo, North Dakota, 58104

  • GSK Investigational Site

    Fenton, Michigan, 48430

  • GSK Investigational Site

    Fort Mill, South Carolina, 29707

  • GSK Investigational Site

    Fresno, California, 93703

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gainesville, Florida, 32605

  • GSK Investigational Site

    Gainesville, Florida, 32610

  • GSK Investigational Site

    Gainesville, Georgia, 30501

  • GSK Investigational Site

    Germantown, Tennessee, 38138

  • GSK Investigational Site

    Glenview, Illinois, 60025

  • GSK Investigational Site

    Gold River, California, 95670

  • GSK Investigational Site

    Granada Hills, California, 91344

  • GSK Investigational Site

    Great Falls, Montana, 59405

  • GSK Investigational Site

    Great Neck, New York, 11023

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Greenville, South Carolina, 29607

  • GSK Investigational Site

    Gresham, Oregon, 97030

  • GSK Investigational Site

    Gun Barrel City, Texas, 75156

  • GSK Investigational Site

    Hampton, Virginia, 23666

  • GSK Investigational Site

    Harbor City, California, 90710

  • GSK Investigational Site

    Hialeah, Florida, 33012

  • GSK Investigational Site

    High Point, North Carolina, 27262

  • GSK Investigational Site

    Houston, Texas, 77036

  • GSK Investigational Site

    Houston, Texas, 77055

  • GSK Investigational Site

    Houston, Texas, 77077

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Huntington Park, California, 90255

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Indianapolis, Indiana, 46208

  • GSK Investigational Site

    Indianapolis, Indiana, 46256

  • GSK Investigational Site

    Irving, Texas, 75039

  • GSK Investigational Site

    Johnson City, New York, 13790

  • GSK Investigational Site

    Johnstown, Pennsylvania, 15904

  • GSK Investigational Site

    Kansas City, Missouri, 64108

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Kansas City, Missouri, 64138

  • GSK Investigational Site

    Katy, Texas, 77450

  • GSK Investigational Site

    Killeen, Texas, 76542

  • GSK Investigational Site

    Kingwood, Texas, 77339

  • GSK Investigational Site

    La Crosse, Wisconsin, 54601

  • GSK Investigational Site

    Lake Oswego, Oregon, 97035

  • GSK Investigational Site

    Largo, Maryland, 20774

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Las Vegas, Nevada, 89107

  • GSK Investigational Site

    Latrobe, Pennsylvania, 15650

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Lewisville, Texas, 75067

  • GSK Investigational Site

    Lexington, Kentucky, 40508

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Lilburn, Georgia, 30047

  • GSK Investigational Site

    Lincoln, Nebraska, 68516

  • GSK Investigational Site

    Lincoln, Rhode Island, 2865

  • GSK Investigational Site

    Little Rock, Arkansas, 72204

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Little Rock, Arkansas, 72209

  • GSK Investigational Site

    Live Oak, Texas, 78233

  • GSK Investigational Site

    Livingston, New Jersey, 07039

  • GSK Investigational Site

    Long Beach, California, 90807

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Louisville, Kentucky, 40291

  • GSK Investigational Site

    Lufkin, Texas, 75904

  • GSK Investigational Site

    Madison, Wisconsin, 53792-9988

  • GSK Investigational Site

    Marion, Ohio, 43302

  • GSK Investigational Site

    Marlton, New Jersey, 08053

  • GSK Investigational Site

    McKenzie, Tennessee, 38201

  • GSK Investigational Site

    Melbourne, Florida, 32935

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Miami, Florida, 33126

  • GSK Investigational Site

    Miami, Florida, 33135

  • GSK Investigational Site

    Miami, Florida, 33142

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Miami, Florida, 33175

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Miami, Florida, 33184

  • GSK Investigational Site

    Miami Lakes, Florida, 33016

  • GSK Investigational Site

    Midlothian, Virginia, 23113

  • GSK Investigational Site

    Midlothian, Virginia, 23114

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Missoula, Montana, 59808

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Montgomery, Alabama, 36109

  • GSK Investigational Site

    Murray, Utah, 84107

  • GSK Investigational Site

    Napa, California, 94558

  • GSK Investigational Site

    Naples, Florida, 34102

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Nashville, Tennessee, 37214

  • GSK Investigational Site

    New Port Richey, Florida, 34652

  • GSK Investigational Site

    Newburgh, New York, 12550

  • GSK Investigational Site

    Newport Beach, California, 92660

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Niles, Michigan, 49120

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    North Syracuse, New York, 13212

  • GSK Investigational Site

    Northfield, New Jersey, 8225

  • GSK Investigational Site

    Oakland, California, 94609

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Ocean City, New Jersey, 07712

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73131

  • GSK Investigational Site

    Omaha, Nebraska, 68130

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Orlando, Florida, 32811

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Overland Park, Kansas, 66210

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Pace, Florida, 32571

  • GSK Investigational Site

    Palmdale, California, 93551

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Pensacola, Florida, 32514

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Ponte Vedra Beach, Florida, 32081

  • GSK Investigational Site

    Port Gibson, Mississippi, 39150

  • GSK Investigational Site

    Puyallup, Washington, 98371

  • GSK Investigational Site

    Richmond, Virginia, 23223

  • GSK Investigational Site

    Richmond, Virginia, 23226

  • GSK Investigational Site

    Richmond, Virginia, 23235

  • GSK Investigational Site

    Riverside, California, 92501

  • GSK Investigational Site

    Rolling Hills Est., California, 920274

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    Roseville, California, 95678

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    Saint Cloud, Florida, 34769

  • GSK Investigational Site

    San Antonio, Texas, 78207

  • GSK Investigational Site

    San Antonio, Texas, 78224

  • GSK Investigational Site

    San Antonio, Texas, 78228

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78251

  • GSK Investigational Site

    San Antonio, Texas, 78299

  • GSK Investigational Site

    San Marino, California, 91108

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    Scottsboro, Alabama, 35768

  • GSK Investigational Site

    Scottsdale, Arizona, 85255

  • GSK Investigational Site

    Scottsdale, Arizona, 85288

  • GSK Investigational Site

    Sealy, Texas, 77474

  • GSK Investigational Site

    Shaker Heights, Ohio, 44120

  • GSK Investigational Site

    Shelby, North Carolina, 28152

  • GSK Investigational Site

    Shelbyville, Tennessee, 37160

  • GSK Investigational Site

    Shiloh, Illinois, 62269

  • GSK Investigational Site

    Shippensburg, Pennsylvania, 17257

  • GSK Investigational Site

    Shreveport, Louisiana, 71106

  • GSK Investigational Site

    Silver Spring, Maryland, 20910

  • GSK Investigational Site

    Somerville, New Jersey, 8876

  • GSK Investigational Site

    St. Petersburg, Florida, 33701

  • GSK Investigational Site

    St. Petersburg, Florida, 33710

  • GSK Investigational Site

    Staten Island, New York, 10304

  • GSK Investigational Site

    Stevensville, Michigan, 49127

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

  • GSK Investigational Site

    Sugar Land, Texas, 77478

  • GSK Investigational Site

    Sugar Land, Texas, 77479

  • GSK Investigational Site

    Sylvania, Ohio, 43560

  • GSK Investigational Site

    Tampa, Florida, 33606

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Toledo, Ohio, 43606

  • GSK Investigational Site

    Toledo, Ohio, 43617

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    Toney, Alabama, 35773

  • GSK Investigational Site

    Tucson, Arizona, 85724-5073

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Tuscaloosa, Alabama, 35401

  • GSK Investigational Site

    Tyler, Texas, 75708

  • GSK Investigational Site

    Utica, New York, 13502

  • GSK Investigational Site

    Verona, New Jersey, 07044

  • GSK Investigational Site

    Virginia Beach, Virginia, 23454

  • GSK Investigational Site

    Waco, Texas, 76710

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Warrensburg, Missouri, 64093

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    Waterbury, Connecticut, 06708

  • GSK Investigational Site

    Waxahachie, Texas, 75165

  • GSK Investigational Site

    Wellington, Florida, 33414

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Covina, California, 91790

  • GSK Investigational Site

    West Des Moines, Iowa, 50265

  • GSK Investigational Site

    West Sacramento, California, 95691

  • GSK Investigational Site

    Westfield, New York, 14787

  • GSK Investigational Site

    Wheeling, Ohio, 26003

  • GSK Investigational Site

    White Marsh, Maryland, 21162

  • GSK Investigational Site

    Woods Cross, Utah, 84087

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

  • GSK Investigational Site

    Zanesville, Ohio, 43701

Other trials in United States

Poland30 sites

  • GSK Investigational Site

    Bialystok, 15-430

  • GSK Investigational Site

    Bialystok

  • GSK Investigational Site

    Cieszyn, 43-400

  • GSK Investigational Site

    Dębica, 39 - 200

  • GSK Investigational Site

    Gdansk, 80-308

  • GSK Investigational Site

    Gdansk, 80-433

  • GSK Investigational Site

    Gdansk, 80-462

  • GSK Investigational Site

    Jelenia Góra, 58-500

  • GSK Investigational Site

    Karpacz, 58-540

  • GSK Investigational Site

    Koszalin, 75-729

  • GSK Investigational Site

    Krakow, 31-023

  • GSK Investigational Site

    Krakow, 31-503

  • GSK Investigational Site

    Lodz, 90-553

  • GSK Investigational Site

    Lodz, 93-513

  • GSK Investigational Site

    Lubin, 59-300

  • GSK Investigational Site

    Lublin, 20-093

  • GSK Investigational Site

    Lublin, 20-552

  • GSK Investigational Site

    Poznan, 60-214

  • GSK Investigational Site

    Rzeszów, 35-241

  • GSK Investigational Site

    Sandomierz, 27-600

  • GSK Investigational Site

    Skarżysko-Kamienna, 26-110

  • GSK Investigational Site

    Skierniewice, 96-100

  • GSK Investigational Site

    Szczecin, 70-382

  • GSK Investigational Site

    Szczecin, 70-780

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Warsaw, 01-157

  • GSK Investigational Site

    Wroclaw, 50-445

  • GSK Investigational Site

    Wroclaw, 53-301

  • GSK Investigational Site

    Zabrze, 41 - 800

  • GSK Investigational Site

    Zabrze, 41-800

Other trials in Poland

Germany20 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Bad Lippspringe, North Rhine-Westphalia, 33175

  • GSK Investigational Site

    Bad Pyrmont, Lower Saxony, 31812

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44791

  • GSK Investigational Site

    Bruchsal, Baden-Wurttemberg, 76646

  • GSK Investigational Site

    Detmold, North Rhine-Westphalia, 32756

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Fürth, Bavaria, 90762

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Hagen, North Rhine-Westphalia, 58089

  • GSK Investigational Site

    Höchstadt an der Aisch, Bavaria, 91315

  • GSK Investigational Site

    Kleve-Materborn, North Rhine-Westphalia, 47533

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Neuss, North Rhine-Westphalia, 41469

  • GSK Investigational Site

    Reinfeld, Schleswig-Holstein, 23858

  • GSK Investigational Site

    Telgte, North Rhine-Westphalia, 48291

  • GSK Investigational Site

    Teuchern, Saxony-Anhalt, 6682

  • GSK Investigational Site

    Weißenhorn, Bavaria, 89264

Other trials in Germany

United Kingdom19 sites

  • GSK Investigational Site

    Atherstone, Warwickshire, CV9 1EU

  • GSK Investigational Site

    Barry, CF63 4AR

  • GSK Investigational Site

    Bath, Somerset, BA2 1NH

  • GSK Investigational Site

    Bexhill-on-Sea, TN40 1JJ

  • GSK Investigational Site

    Brighton, Sussex East, BN2 5BE

  • GSK Investigational Site

    Cardiff, Glamorgan, CF5 4AE

  • GSK Investigational Site

    Chesterfield, Derbyshire, S40 4TF

  • GSK Investigational Site

    Doncaster, DN9 2HY

  • GSK Investigational Site

    Glasgow, G3 8SJ

  • GSK Investigational Site

    Kent, CT5 3QU

  • GSK Investigational Site

    Leicester, LE1 5WW

  • GSK Investigational Site

    Macclesfield, SK10 3BL

  • GSK Investigational Site

    Merseyside, CH41 0DD

  • GSK Investigational Site

    Newcastle upon Tyne, Northumberland, NE1 4LP

  • GSK Investigational Site

    Penzance, TK19 7HX

  • GSK Investigational Site

    Peterborough, PE8 6PL

  • GSK Investigational Site

    Stockton-on-Tees, TS19 8PE

  • GSK Investigational Site

    Stoke-on-Trent, ST4 6QG

  • GSK Investigational Site

    Surrey, RH1 5RH

Other trials in United Kingdom

South Africa16 sites

  • GSK Investigational Site

    Benoni, Gauteng, 1501

  • GSK Investigational Site

    Benoni, 1501

  • GSK Investigational Site

    Cape Town, 7441

  • GSK Investigational Site

    Cape Town, 7500

  • GSK Investigational Site

    Cape Town, 7572

  • GSK Investigational Site

    Cape Town, 7700

  • GSK Investigational Site

    Claremont, 7708

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Krugersdorp, Gauteng, 1752

  • GSK Investigational Site

    Middelburg, 1501

  • GSK Investigational Site

    Paarl, 7646

  • GSK Investigational Site

    Pretoria, Gauteng, 0132

  • GSK Investigational Site

    Pretoria, 0001

  • GSK Investigational Site

    Pretoria, 0002

  • GSK Investigational Site

    Thabazimbi, 0380

  • GSK Investigational Site

    Welkom, Free State, 9460

Other trials in South Africa

Ukraine15 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49100

  • GSK Investigational Site

    Dnipropetrovsk, 49101

  • GSK Investigational Site

    Kharkiv, 61050

  • GSK Investigational Site

    Kharkiv, 61093

  • GSK Investigational Site

    Kryvyi Rih, 50082

  • GSK Investigational Site

    Kyiv, 4050

  • GSK Investigational Site

    Kyiv

  • GSK Investigational Site

    Lviv, 79059

  • GSK Investigational Site

    Odesa, 65031

  • GSK Investigational Site

    Odesa, 65038

  • GSK Investigational Site

    Poltava, 36011

  • GSK Investigational Site

    Simferopol, 95006

  • GSK Investigational Site

    Sumy, 40031

  • GSK Investigational Site

    Uzhhorod, 88009

  • GSK Investigational Site

    Zaporizhia, 69063

Other trials in Ukraine

Russia14 sites

  • GSK Investigational Site

    Moscow, 119435

  • GSK Investigational Site

    Moscow, 119991

  • GSK Investigational Site

    Moscow, 125412

  • GSK Investigational Site

    Nizhny Novgorod, 603005

  • GSK Investigational Site

    Novosibirsk, 630099

  • GSK Investigational Site

    Saint Petersburg, 192212

  • GSK Investigational Site

    Saint Petersburg, 194100

  • GSK Investigational Site

    Saint Petersburg, 196084

  • GSK Investigational Site

    Saint Petersburg, 196657

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    St'Petersburg, 191144

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Voronezh, 394036

  • GSK Investigational Site

    Yaroslavl, 150003

Other trials in Russia

Argentina12 sites

  • GSK Investigational Site

    Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires, 7000

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Capital Federal, C1270AAN

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1122AAK

  • GSK Investigational Site

    Concepción del Uruguay, Entre Ríos Province, 3260

  • GSK Investigational Site

    Lanus, B1824KAJ

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Nueve de Julio, Buenos Aires, B6500BWQ

  • GSK Investigational Site

    Paraná, Entre Ríos Province, E3100BHK

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IFL

Other trials in Argentina

Bulgaria12 sites

  • GSK Investigational Site

    Blagoevgrad, 2700

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Rousse, 7002

  • GSK Investigational Site

    Sevlievo, 5400

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Stara Zagora, 6000

  • GSK Investigational Site

    Varna, 9000

  • GSK Investigational Site

    Varna, 9010

  • GSK Investigational Site

    Veliko Tarnovo, 5000

  • GSK Investigational Site

    Vidin, 3700

Other trials in Bulgaria

South Korea11 sites

  • GSK Investigational Site

    Cheongju-si, 361-711

  • GSK Investigational Site

    Gyeonggi-do, 463-712

  • GSK Investigational Site

    Gyeonggi-do, 471-020

  • GSK Investigational Site

    Gyeonggi-do, 480-717

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Pusan, 612030

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 130-702

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 143-729

Other trials in South Korea

Hungary9 sites

  • GSK Investigational Site

    Baja, 6500

  • GSK Investigational Site

    Budapest, 1037

  • GSK Investigational Site

    Budapest, 1089

  • GSK Investigational Site

    Budapest, 1146

  • GSK Investigational Site

    Miskolc, 3501

  • GSK Investigational Site

    Nagykanizsa, 08800

  • GSK Investigational Site

    Ráckeve, 2300

  • GSK Investigational Site

    Szekszárd, 7100

  • GSK Investigational Site

    Törökbálint, 2045

Other trials in Hungary

Italy8 sites

  • GSK Investigational Site

    Brescia, 25123

  • GSK Investigational Site

    Messina, 98123

  • GSK Investigational Site

    Milan, Lombardy, 20129

  • GSK Investigational Site

    Milan, 20142

  • GSK Investigational Site

    Palermo, 90146

  • GSK Investigational Site

    Roma, 00168

  • GSK Investigational Site

    Rome, Lazio, 00157

  • GSK Investigational Site

    Sesto San Giovanni, 20099

Other trials in Italy

Taiwan8 sites

  • GSK Investigational Site

    Changhua, 500

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Kaohsiung City, 813

  • GSK Investigational Site

    Taichung, 402

  • GSK Investigational Site

    Taichung, 40447

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 11031

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Peru7 sites

  • GSK Investigational Site

    Lima, Lima 18

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    Lima, Lima 27

  • GSK Investigational Site

    Miraflores, Lima region, 18

  • GSK Investigational Site

    San Borja, L36

  • GSK Investigational Site

    San Martín de Porres, Lima region, Lima 31

  • GSK Investigational Site

    Santiago de Surco, Lima region, Lima 33

Other trials in Peru

Thailand7 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok

  • GSK Investigational Site

    Bangkoknoi, 10700

  • GSK Investigational Site

    Khon Kaen, 40002

  • GSK Investigational Site

    Pathum Thani, 12120

  • GSK Investigational Site

    Phitsanulok, 65000

  • GSK Investigational Site

    Ratchatewi, 10400

Other trials in Thailand

Croatia6 sites

  • GSK Investigational Site

    Čakovec, 40000

  • GSK Investigational Site

    Dubrovnik, 20000

  • GSK Investigational Site

    Jastrebarsko, 10450

  • GSK Investigational Site

    Rijeka, 51000

  • GSK Investigational Site

    Split, 21000

  • GSK Investigational Site

    Zagreb, 10000

Other trials in Croatia

Malaysia6 sites

  • GSK Investigational Site

    Ipoh, 32040

  • GSK Investigational Site

    Kuala Lumpur, 59100

  • GSK Investigational Site

    Kuching, 93586

  • GSK Investigational Site

    Seremban, Negeri Sembilan, 70300

  • GSK Investigational Site

    Sibu, 96000

  • GSK Investigational Site

    Sungai Buloh, 47000

Other trials in Malaysia

Spain6 sites

  • GSK Investigational Site

    Barcelona, 08022

  • GSK Investigational Site

    Burgos, 09005

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Sabadell (Barcelona), 8208

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

Australia5 sites

  • GSK Investigational Site

    Auchenflower, Queensland, 4066

  • GSK Investigational Site

    Parkville, 3052

  • GSK Investigational Site

    Randwick, 2031

  • GSK Investigational Site

    Subiaco, Western Australia, 6008

  • GSK Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium5 sites

  • GSK Investigational Site

    Antwerp, 2018

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Gembloux, 5030

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Natoye, 5360

Other trials in Belgium

Canada5 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T3J1

  • GSK Investigational Site

    Burlington, Ontario, L7L 0B7

  • GSK Investigational Site

    Oshawa, Ontario, L1H 7K4

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Windsor, Ontario, N8X 2G1

Other trials in Canada

Czechia5 sites

  • GSK Investigational Site

    Brno, 615 00

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Česká Lípa, 470 01

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Prague, 147 00

Other trials in Czechia

Latvia5 sites

  • GSK Investigational Site

    Riga, 1011

  • GSK Investigational Site

    Riga, 1063

  • GSK Investigational Site

    Riga, LV 1003

  • GSK Investigational Site

    Riga, LV 1004

  • GSK Investigational Site

    Tukums, 3101

Other trials in Latvia

Lithuania5 sites

  • GSK Investigational Site

    Kaunas, LT-49449

  • GSK Investigational Site

    Kaunas, LT-50009

  • GSK Investigational Site

    Utena, LT-28151

  • GSK Investigational Site

    Vilnius, LT-04338

  • GSK Investigational Site

    Vilnius, LT-08406

Other trials in Lithuania

Mexico5 sites

  • GSK Investigational Site

    Chihuahua City, 31020

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    Huixquilucan, 52763

  • GSK Investigational Site

    Monterrey, Nuevo León, 64710

  • GSK Investigational Site

    Monterrey, 64718

Other trials in Mexico

Philippines5 sites

  • GSK Investigational Site

    Dasmariñas, Cavite, 4114

  • GSK Investigational Site

    Davao City, 8000

  • GSK Investigational Site

    Pulilan, 3005

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    Quezon City, 1108

Other trials in Philippines

Serbia5 sites

  • GSK Investigational Site

    Belgrade, 11000

  • GSK Investigational Site

    Čačak, 32000

  • GSK Investigational Site

    Niš, 18000

  • GSK Investigational Site

    Novi Sad, 21 000

  • GSK Investigational Site

    Užice, 31000

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Austria3 sites

  • GSK Investigational Site

    Bregenz, A-6900

  • GSK Investigational Site

    Feldkirch, 6800

  • GSK Investigational Site

    Vienna, 1090

Other trials in Austria

Chile3 sites

  • GSK Investigational Site

    Santiago, 7560994

  • GSK Investigational Site

    Valdivia, 5090146

  • GSK Investigational Site

    Viña del Mar, 2570017

Other trials in Chile

Slovakia3 sites

  • GSK Investigational Site

    Martin, 036 59

  • GSK Investigational Site

    Nitra, 949 01

  • GSK Investigational Site

    Trnava, 917 01

Other trials in Slovakia

Romania2 sites

  • GSK Investigational Site

    Bucharest, 20395

  • GSK Investigational Site

    Sibiu, 550166

Other trials in Romania

Colombia1 site

  • GSK Investigational Site

    Medellín

Other trials in Colombia

About this study

Official 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

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.

Read the detailed description

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in May of 2016. This is the final update, as this study is complete.

Conditions
Asthma
Being tested
ADVAIR 100/50mcg, ADVAIR 250/50mcg, FLOVENT 100mcg, FLOVENT 250mcg
Keywords
pediatric, ADVAIR, FLOVENT, asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADVAIR 100/50mcgDrug

    Also called FSC 100/50

    fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

  • ADVAIR 250/50mcgDrug

    Also called FSC 250/50

    fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

  • FLOVENT 100mcgDrug

    Also called FP 100

    fluticasone propionate (100) twice daily (AM and PM) for 6 months

  • FLOVENT 250mcgDrug

    Also called FP 250

    fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

Study groups in NCT01462344
Study groupRoleWhat they receive
ADVAIR 100/50mcgExperimentalfluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
Receives: Drug: ADVAIR 100/50mcg
ADVAIR 250/50mcgExperimentalfluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Receives: Drug: ADVAIR 250/50mcg
FLOVENT 100mcgActive comparatorfluticasone propionate (100) twice daily (AM and PM) for 6 months
Receives: Drug: FLOVENT 100mcg
FLOVENT 250mcgActive comparatorfluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Receives: Drug: FLOVENT 250mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Day 1 up to 6 months

  2. 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.

    Measured: From Day 1 up to 6 months

Secondary outcomes (6)

  1. Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.

    Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.

    Measured: From Day 1 up to 6 months

  2. Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period

    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.

    Measured: From Day 1 up to 6 months

  3. Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period

    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.

    Measured: From Day 1 up to 6 months

  4. Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period

    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.

    Measured: From Day 1 up to 6 months

  5. Percentage of Rescue-free Days Over the 6-month Study Treatment Period

    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.

    Measured: From Day 1 up to 6 months

  6. Percentage of Asthma Control Days Over the 6-month Study Treatment Period

    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.

    Measured: From Day 1 up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2011 (estimated)
  2. Study start17 Nov 2011
  3. Primary completion1 Nov 2015
  4. Study completion3 Nov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462344
Sponsor's protocol ID
115358
Acronym
VESTRI
Status last verified
Aug 2018
First submitted
27 Oct 2011
Last updated
6 Aug 2018
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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.

    PubMed 32966707

  • 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.

    PubMed 27579634

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ADVAIR 100/50mcg, ADVAIR 250/50mcg and FLOVENT 100mcg in people with Asthma, run by GlaxoSmithKline at 530 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 530 sites in United States, Poland, Germany, United Kingdom, South Africa and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From Day 1 up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01462344, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.

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