AsthmaPhase 4AUSTRINCT01475721

SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

A Phase 4 study testing ADVAIR 100/50mcg, ADVAIR 250/50mcg and ADVAIR 500/50mcg in people with Asthma, run by GlaxoSmithKline at 808 sites in 33 countries.

Completed

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

Official record

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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 adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: ADVAIR 100/50mcg, ADVAIR 250/50mcg and ADVAIR 500/50mcg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11,751 participants
Where: 808 sitesin 33 countries
Study dates: 18 Nov 2011to 23 Jun 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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Provided consent to participate in the study
Male or female, 12 years of age and older
Clinical diagnosis of asthma for at least 1 year prior to the randomization
Clinic PEF of greater than or equal to 50% of predicted normal value
Subject must be appropriately using one of the treatments for asthma listed in the protocol
Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler

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Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
requiring treatment with systemic corticosteroids
an asthma-related hospitalization

Who cannot join

History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
Concurrent respiratory disease other than asthma
Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
Presence of a bacterial or viral respiratory infection that is not resolved at randomization
An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization

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More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
Subject must not meet unstable asthma severity criteria as listed in the protocol
Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
Pregnancy, breast-feeding or planned pregnancy during the study
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

808 sites in 33 countries.

Country

City, postcode or hospital

758 sites in 33 countries

United States300 sites

GSK Investigational Site
Albuquerque, New Mexico, 87131
GSK Investigational Site
Alexandria, Louisiana, 71301
GSK Investigational Site
Alexandria, Virginia, 22304
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Ann Arbor, Michigan, 48106
GSK Investigational Site
Annapolis, Maryland, 21401
GSK Investigational Site
Arlington, Texas, 76018
GSK Investigational Site
Asheboro, North Carolina, 27203
GSK Investigational Site
Asheville, North Carolina, 28803
GSK Investigational Site
Atco, New Jersey, 08004
GSK Investigational Site
Athens, Alabama, 35611
GSK Investigational Site
Austell, Georgia, 30106
GSK Investigational Site
Austin, Texas, 78731
GSK Investigational Site
Austin, Texas, 78758
GSK Investigational Site
Austin, Texas, 78759-8950
GSK Investigational Site
Avon, Indiana, 46123
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
Baltimore, Maryland, 21224
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Belle Vernon, Pennsylvania, 15012
GSK Investigational Site
Belle Vernon, Pennsylvania, 15025
GSK Investigational Site
Bellevue, Nebraska, 68005
GSK Investigational Site
Bellingham, Washington, 98225
GSK Investigational Site
Bensalem, Pennsylvania, 19020
GSK Investigational Site
Billings, Montana, 59101
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Birmingham, Alabama, 35216
GSK Investigational Site
Birmingham, Alabama, 35233
GSK Investigational Site
Bountiful, Utah, 84010
GSK Investigational Site
Boynton Beach, Florida, 33437
GSK Investigational Site
Brandon, Florida, 33511
GSK Investigational Site
Brick, New Jersey, 08724
GSK Investigational Site
Brooklyn, New York, 11215
GSK Investigational Site
Brownsburg, Indiana, 46112
GSK Investigational Site
Buckley, Michigan, 49620
GSK Investigational Site
Calabash, North Carolina, 28467
GSK Investigational Site
Carnegie, Pennsylvania, 15106
GSK Investigational Site
Cary, North Carolina, 27518
GSK Investigational Site
Centerville, Ohio, 45459
GSK Investigational Site
Champaign, Illinois, 61820
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Charlottesville, Virginia, 22902
GSK Investigational Site
Chaska, Minnesota, 55318
GSK Investigational Site
Chattanooga, Tennessee, 37404
GSK Investigational Site
Chattanooga, Tennessee, 37411
GSK Investigational Site
Chattanooga, Tennessee, 37421
GSK Investigational Site
Chelsea, Michigan, 48118
GSK Investigational Site
Chesterfield, Michigan, 48047
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cincinnati, Ohio, 45236
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Clearwater, Florida, 33759
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, 80906
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Colorado Springs, Colorado, 80909
GSK Investigational Site
Colorado Springs, Colorado, 80922
GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Corning, New York, 14830
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
Council Bluffs, Iowa, 51503
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Crown Point, Indiana, 46307
GSK Investigational Site
Dakota Dunes, South Dakota, 57049
GSK Investigational Site
Dallas, Texas, 75225
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Dallas, Texas, 75254
GSK Investigational Site
Danbury, Connecticut, 06810
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
Dayton, Ohio, 45459
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Destin, Florida, 32541
GSK Investigational Site
Detroit, Michigan, 48221
GSK Investigational Site
Detroit, Michigan, 48235
GSK Investigational Site
Dinuba, California, 93618
GSK Investigational Site
Doral, Florida, 33166
GSK Investigational Site
Doral, Florida, 33172
GSK Investigational Site
Downingtown, Pennsylvania, 19335
GSK Investigational Site
Duncanville, Texas, 75116
GSK Investigational Site
East Greenwich, Rhode Island, 02818
GSK Investigational Site
Edison, New Jersey, 08817
GSK Investigational Site
Edison, New Jersey, 08820
GSK Investigational Site
Elizabeth, New Jersey, 07201
GSK Investigational Site
Elizabeth, New Jersey, 07202
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Evergreen Park, Illinois, 60805
GSK Investigational Site
Fall River, Massachusetts, 02720
GSK Investigational Site
Falls Church, Vermont, 22044
GSK Investigational Site
Fargo, North Dakota, 58103
GSK Investigational Site
Fargo, North Dakota, 58104
GSK Investigational Site
Fenton, Michigan, 48430
GSK Investigational Site
Flagstaff, Arizona, 86001
GSK Investigational Site
Florence, Alabama, 35630
GSK Investigational Site
Florence, South Carolina, 29501
GSK Investigational Site
Fort Collins, Colorado, 80538
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Franklin, Indiana, 46131
GSK Investigational Site
Freehold, New Jersey, 07728
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Gainesville, Georgia, 30501
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Glen Ellyn, Illinois, 60137
GSK Investigational Site
Glenview, Illinois, 60025
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Goodyear, Arizona, 85395
GSK Investigational Site
Granada Hills, California, 91344
GSK Investigational Site
Great Falls, Montana, 59405
GSK Investigational Site
Green Valley, Arizona, 85614
GSK Investigational Site
Greenfield, Indiana, 46140
GSK Investigational Site
Greenville, South Carolina, 29607
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Greenwood, South Carolina, 29646
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Groveport, Ohio, 43125
GSK Investigational Site
Gun Barrel City, Texas, 75156
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Harbor City, California, 90710
GSK Investigational Site
Hazard, Kentucky, 41701
GSK Investigational Site
Henderson, Nevada, 89014
GSK Investigational Site
Hialeah, Florida, 33016
GSK Investigational Site
Holland, Pennsylvania, 18966
GSK Investigational Site
Hollywood, Maryland, 20636
GSK Investigational Site
Houston, Texas, 77034
GSK Investigational Site
Houston, Texas, 77043
GSK Investigational Site
Houston, Texas, 77055
GSK Investigational Site
Houston, Texas, 77077
GSK Investigational Site
Houston, Texas, 77079
GSK Investigational Site
Huntingdon Valley, Pennsylvania, 19006
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Huntington Park, California, 90255
GSK Investigational Site
Hutchinson, Kansas, 67502
GSK Investigational Site
Hyannis, Massachusetts, 02601
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Indianapolis, Indiana, 46256
GSK Investigational Site
Interlochen, Michigan, 49643
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Irving, Texas, 75061
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Jenkintown, Pennsylvania, 19046
GSK Investigational Site
Johnston, Rhode Island, 02919
GSK Investigational Site
Jupiter, Florida, 33458
GSK Investigational Site
Kalamazoo, Michigan, 49009
GSK Investigational Site
Kansas City, Missouri, 64114
GSK Investigational Site
Kansas City, Missouri, 64138
GSK Investigational Site
Katy, Texas, 77450
GSK Investigational Site
Kerrville, Texas, 78028
GSK Investigational Site
Killeen, Texas, 76542
GSK Investigational Site
Kingwood, Texas, 77339
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Lansdale, Pennsylvania, 19446
GSK Investigational Site
Largo, Maryland, 20774
GSK Investigational Site
Las Vegas, Nevada, 89106
GSK Investigational Site
Las Vegas, Nevada, 89107
GSK Investigational Site
Las Vegas, Nevada, 89183
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, 40504
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Lexington, North Carolina, 27295
GSK Investigational Site
Lilburn, Georgia, 30047
GSK Investigational Site
Lincoln, Nebraska, 02865
GSK Investigational Site
Lincoln, Nebraska, 68512
GSK Investigational Site
Lincoln, Nebraska, 68516
GSK Investigational Site
Lomita, California, 90717
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Long Beach, California, 90807
GSK Investigational Site
Long Beach, California, 90813
GSK Investigational Site
Los Angeles, California, 90057
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Louisville, Kentucky, 40207
GSK Investigational Site
Louisville, Kentucky, 40291
GSK Investigational Site
Lufkin, Texas, 75904
GSK Investigational Site
Lumberton, New Jersey, 08048
GSK Investigational Site
Madison, Wisconsin, 53792-9988
GSK Investigational Site
Maitland, Florida, 32751
GSK Investigational Site
Marion, Ohio, 43302
GSK Investigational Site
Marlton, New Jersey, 08053
GSK Investigational Site
McKenzie, Tennessee, 38201
GSK Investigational Site
McKinney, Texas, 75071
GSK Investigational Site
Melbourne, Florida, 32935
GSK Investigational Site
Mesa, Arizona, 85203
GSK Investigational Site
Mesa, Arizona, 85206
GSK Investigational Site
Miami, Florida, 33015
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
Miami, Florida, 33126
GSK Investigational Site
Miami, Florida, 33155
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Miami, Florida, 33165
GSK Investigational Site
Miami, Florida, 33175
GSK Investigational Site
Middleburg Heights, Ohio, 44130
GSK Investigational Site
Midlothian, Virginia, 23113
GSK Investigational Site
Midlothian, Virginia, 23114
GSK Investigational Site
Midvale, Utah, 84047
GSK Investigational Site
Milford, Connecticut, 06460
GSK Investigational Site
Minneapolis, Minnesota, 55440
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Montgomery, Alabama, 36109
GSK Investigational Site
Morganton, North Carolina, 28655
GSK Investigational Site
Morgantown, West Virginia, 26505
GSK Investigational Site
Muncie, Indiana, 47304-5547
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
Napa, California, 94558
GSK Investigational Site
New Port Richey, Florida, 34652
GSK Investigational Site
New Windsor, New York, 12553
GSK Investigational Site
New York, New York, 10017
GSK Investigational Site
New York, New York, 10022 11209
GSK Investigational Site
Newburgh, New York, 12550
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
Novi, Michigan, 48375
GSK Investigational Site
Oak Lawn, Illinois, 60453
GSK Investigational Site
Oak Park, Illinois, 60302
GSK Investigational Site
Ocean City, New Jersey, 07712
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Omaha, Nebraska, 68130
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
Overland Park, Kansas, 66215
GSK Investigational Site
Oxnard, California, 93030
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Pell City, Alabama, 35128
GSK Investigational Site
Pensacola, Florida, 32514
GSK Investigational Site
Peoria, Arizona, 85381
GSK Investigational Site
Philadelphia, Pennsylvania, 19115
GSK Investigational Site
Philadelphia, Pennsylvania, 19152
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Phoenix, Arizona, 85051
GSK Investigational Site
Phoenix, Arizona, 92120-4915
GSK Investigational Site
Pinellas Park, Florida, 33781
GSK Investigational Site
Pismo Beach, California, 93449
GSK Investigational Site
Pittsburgh, Pennsylvania, 15206
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Plano, Texas, 75024
GSK Investigational Site
Plano, Texas, 75075
GSK Investigational Site
Pomona, California, 91767
GSK Investigational Site
Port Gibson, Mississippi, 39150
GSK Investigational Site
Port Orchard, Washington, 98366
GSK Investigational Site
Portland, Maine, 4101
GSK Investigational Site
Puyallup, Washington, 98371
GSK Investigational Site
Rapid City, South Dakota, 57702
GSK Investigational Site
Richmond, Virginia, 23223
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Richmond, Virginia, 23233
GSK Investigational Site
Richmond, Virginia, 23235
GSK Investigational Site
Ridgewood, New Jersey, 07450
GSK Investigational Site
Rincon, Georgia, 31326
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
Roseville, California, 95678
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
Sacramento, California, 95841
GSK Investigational Site
Saint Cloud, Florida, 34769
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Antonio, Texas, 78233
GSK Investigational Site
San Antonio, Texas, 78238
GSK Investigational Site
San Antonio, Texas, 78251
GSK Investigational Site
San Antonio, Texas, 78258
GSK Investigational Site
San Gabriel, California, 91776
GSK Investigational Site
San Jose, California, 95116
GSK Investigational Site
San Marcos, California, 92078-4081
GSK Investigational Site
San Marino, California, 91108
GSK Investigational Site
San Ramon, California, 94583
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Sarasota, Florida, 34233
GSK Investigational Site
Scottdale, Pennsylvania, 15683
GSK Investigational Site
Scottsboro, Alabama, 35768
GSK Investigational Site
Scottsdale, Arizona, 85255
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
Sierra Vista, Arizona, 85635
GSK Investigational Site
Silver Spring, Maryland, 20910
GSK Investigational Site
Sioux Falls, South Dakota, 57108
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Springfield, Ohio, 45504

Other trials in United States

Germany84 sites

GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Auerbach, Saxony, 08209
GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Augsburg, Bavaria, 86156
GSK Investigational Site
Bad Arolsen, Hesse, 34454
GSK Investigational Site
Bad Lippspringe, North Rhine-Westphalia, 33175
GSK Investigational Site
Bad Pyrmont, Lower Saxony, 31812
GSK Investigational Site
Bad Woerrishofen, Bavaria, 86825
GSK Investigational Site
Beckum, North Rhine-Westphalia, 59269
GSK Investigational Site
Bensheim, Hesse, 64625
GSK Investigational Site
Bergisch Gladbach, North Rhine-Westphalia, 51429
GSK Investigational Site
Berlin, 10629
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 12099
GSK Investigational Site
Berlin, 12157
GSK Investigational Site
Berlin, 12165
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Berlin, 13156
GSK Investigational Site
Berlin, 13187
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Berlin, 14050
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Böhlen, Saxony, 04564
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53119
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53123
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326
GSK Investigational Site
Delitzsch, Saxony, 04509
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Dillingen, Saarland, 66763
GSK Investigational Site
Engelskirchen, North Rhine-Westphalia, 51766
GSK Investigational Site
Essen, North Rhine-Westphalia, 45136
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Feldkirchen, Bavaria, 83620
GSK Investigational Site
Frankenberg, Hesse, 35066
GSK Investigational Site
Frankfurt am Main, Hesse, 60318
GSK Investigational Site
Frankfurt am Main, Hesse, 60320
GSK Investigational Site
Fürth, Bavaria, 90762
GSK Investigational Site
Gars Am Inn, Bavaria, 83536
GSK Investigational Site
Georgensgmünd, Bavaria, 91166
GSK Investigational Site
Göttingen, Lower Saxony, 37081
GSK Investigational Site
Großheirath, Bavaria, 96269
GSK Investigational Site
Hagen, North Rhine-Westphalia, 58089
GSK Investigational Site
Hamburg, 20354
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Hamburg, 22335
GSK Investigational Site
Hamburg, 22767
GSK Investigational Site
Herne, North Rhine-Westphalia, 44629
GSK Investigational Site
Höchstadt an der Aisch, Bavaria, 91315
GSK Investigational Site
Klappholz, Schleswig-Holstein, 24860
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Lahnau, Hesse, 35633
GSK Investigational Site
Leipzig, Saxony, 04357
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Meissen, Saxony, 1662
GSK Investigational Site
Munich, Bavaria, 80335
GSK Investigational Site
Munich, Bavaria, 80337
GSK Investigational Site
Münster, North Rhine-Westphalia, 48149
GSK Investigational Site
Neuötting, Bavaria, 84524
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41469
GSK Investigational Site
Offenbach, Hesse, 63071
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Potsdam, Brandenburg, 14478
GSK Investigational Site
Rathenow, Brandenburg, 14712
GSK Investigational Site
Ratingen, North Rhine-Westphalia, 40878
GSK Investigational Site
Raubach, Rhineland-Palatinate, 56316
GSK Investigational Site
Reinfeld, Schleswig-Holstein, 23858
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Rodgau, Hesse, 63110
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428
GSK Investigational Site
Saarbrücken, Saarland, 66111
GSK Investigational Site
Schwalmstadt, Hesse, 34613
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42651
GSK Investigational Site
Telgte, North Rhine-Westphalia, 48291
GSK Investigational Site
Teuchern, Saxony-Anhalt, 6682
GSK Investigational Site
Vilshofen, Bavaria, 94474
GSK Investigational Site
Weißenhorn, Bavaria, 89264
GSK Investigational Site
Witten, North Rhine-Westphalia, 58452
GSK Investigational Site
Wolfsburg, Lower Saxony, 38448
GSK Investigational Site
Wuppertal, North Rhine-Westphalia, 42117
GSK Investigational Site
Zerbst, Saxony-Anhalt, 39261

Other trials in Germany

Poland38 sites

GSK Investigational Site
Bielsko-Biala, 43-300
GSK Investigational Site
Brzesko, 32-800
GSK Investigational Site
Bydgoszcz, 85-168
GSK Investigational Site
Bystra, 43-360
GSK Investigational Site
Cieszyn, 43-400
GSK Investigational Site
Dębica, 39 - 200
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Gdansk, 80-433
GSK Investigational Site
Gdansk, 84-462
GSK Investigational Site
Głuchołazy, 41-340
GSK Investigational Site
Jelenia Góra, 58-500
GSK Investigational Site
Krakow, 31-202
GSK Investigational Site
Libiąż, 32-590
GSK Investigational Site
Lodz, 90-302
GSK Investigational Site
Lodz, 90-430
GSK Investigational Site
Lodz, 91-357
GSK Investigational Site
Lodz, 93-513
GSK Investigational Site
Lubin, 59-300
GSK Investigational Site
Lublin, 20-093
GSK Investigational Site
Olsztyn, 10-357
GSK Investigational Site
Poznan, 60-214
GSK Investigational Site
Radomsko, 97-500
GSK Investigational Site
Ruda Śląska, 41-709
GSK Investigational Site
Rudka, 05-320
GSK Investigational Site
Rzeszów, 35-241
GSK Investigational Site
Sandomierz, 27-600
GSK Investigational Site
Sopot, 81-741
GSK Investigational Site
Szczecin, 70-111
GSK Investigational Site
Warsaw, 01-138
GSK Investigational Site
Warsaw, 01-157
GSK Investigational Site
Warsaw, 04-141
GSK Investigational Site
Wodzisław Śląski, 44-300
GSK Investigational Site
Wołomin, 05-200
GSK Investigational Site
Wroclaw, 53-301
GSK Investigational Site
Wroclaw, 54-239
GSK Investigational Site
Zabrze, 41 - 800
GSK Investigational Site
Zabrze, 41-800
GSK Investigational Site
Zgierz, 95-100

Other trials in Poland

Russia37 sites

GSK Investigational Site
Chelyabinsk, 454021
GSK Investigational Site
Kemerovo, 650000
GSK Investigational Site
Kemerovo, 650002
GSK Investigational Site
Kirov, 610027
GSK Investigational Site
Krasnodar, 350063
GSK Investigational Site
Krasnoyarsk, 660022
GSK Investigational Site
Moscow, 110020
GSK Investigational Site
Moscow, 115432
GSK Investigational Site
Moscow, 117593
GSK Investigational Site
Moscow, 119121
GSK Investigational Site
Moscow, 123182
GSK Investigational Site
Moscow, 125167
GSK Investigational Site
Moscow, 125205
GSK Investigational Site
Moscow, 125412
GSK Investigational Site
Moscow, 127018
GSK Investigational Site
Novosibirsk, 630051
GSK Investigational Site
Novosibirsk, 630087
GSK Investigational Site
Novosibirsk, 630089
GSK Investigational Site
Novosibirsk, 630091
GSK Investigational Site
Novosibirsk, 630099
GSK Investigational Site
Orenburg, 460018
GSK Investigational Site
Pyatigorsk, 357538
GSK Investigational Site
Rostov-on-Don, 344091
GSK Investigational Site
Ryazan, 390026
GSK Investigational Site
Saint Petersburg, 192212
GSK Investigational Site
Saint Petersburg, 194354
GSK Investigational Site
Saint Petersburg, 195067
GSK Investigational Site
Saint Petersburg, 195112
GSK Investigational Site
Saint Petersburg, 196084
GSK Investigational Site
Saint Petersburg, 196657
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Saratov, 410018
GSK Investigational Site
Tomsk, 634 050
GSK Investigational Site
Tomsk, 634063
GSK Investigational Site
Velikiy Novgorod, 173008
GSK Investigational Site
Voronezh, 394018
GSK Investigational Site
Yaroslavl, 150003

Other trials in Russia

Ukraine28 sites

GSK Investigational Site
Cherkassy, 18009
GSK Investigational Site
Dnipropetrovsk, 49027
GSK Investigational Site
Dnipropetrovsk, 49101
GSK Investigational Site
Donetsk, 83059
GSK Investigational Site
Ivano-Frankivsk, 76008
GSK Investigational Site
Kharkiv, 61002
GSK Investigational Site
Kharkiv, 61039
GSK Investigational Site
Kharkiv, 61050
GSK Investigational Site
Kharkiv, 61103
GSK Investigational Site
Kharkiv, 61157
GSK Investigational Site
Kiev, 03680
GSK Investigational Site
Kryvyi Rih, 50082
GSK Investigational Site
Kyiv, 04201
GSK Investigational Site
Kyiv
GSK Investigational Site
Lviv, 79059
GSK Investigational Site
Odesa, 65010
GSK Investigational Site
Odesa, 65117
GSK Investigational Site
Odesa, 85038
GSK Investigational Site
Poltava, 36011
GSK Investigational Site
Simferopol, 95006
GSK Investigational Site
Sumy, 40022
GSK Investigational Site
Sumy, 40030
GSK Investigational Site
Sumy, 40031
GSK Investigational Site
Ternopil, 46000
GSK Investigational Site
Vinnytsia, 21018
GSK Investigational Site
Zaporizhzhya, 69001
GSK Investigational Site
Zaporizhzhya, 69600
GSK Investigational Site
Zhytomyr, 10002

Other trials in Ukraine

Spain26 sites

GSK Investigational Site
A Coruña, 15006
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 8036
GSK Investigational Site
Basurto/Bilbao, 48013
GSK Investigational Site
Burgos, 09005
GSK Investigational Site
Cadiz, 10009
GSK Investigational Site
Canet de Mar - Barcelona, 08360
GSK Investigational Site
Elche, 12203
GSK Investigational Site
Illescas-Toledo, 45004
GSK Investigational Site
Lleida, 25198
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Madrid, 28805
GSK Investigational Site
Majadahonda (Madrid), 28222
GSK Investigational Site
Mataró, 08303
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223
GSK Investigational Site
Sabadell (Barcelona), 08208
GSK Investigational Site
Sagunto/Valencia, 46520
GSK Investigational Site
Sant Boi de Llobregat, 08830
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Tarrasa, Barcelona, 08221
GSK Investigational Site
Torrelavega, 39300
GSK Investigational Site
Valencia, 46026
GSK Investigational Site
Valladolid, 47012
GSK Investigational Site
Vic (Barcelona), 08500

Other trials in Spain

South Africa23 sites

GSK Investigational Site
Bellville, 7531
GSK Investigational Site
Benoni, 1501
GSK Investigational Site
Cape Town, Gauteng, 7505
GSK Investigational Site
Cape Town, 7441
GSK Investigational Site
Cape Town, 7500
GSK Investigational Site
Cape Town, 7570
GSK Investigational Site
Cape Town, 7700
GSK Investigational Site
Claremont, 7708
GSK Investigational Site
Die Wilgers, 0184
GSK Investigational Site
Durban, 4001
GSK Investigational Site
Durban, 4071
GSK Investigational Site
Eloffsdal, Gauteng, 0084
GSK Investigational Site
Gatesville, 7764
GSK Investigational Site
Krugersdorp, Gauteng, 1752
GSK Investigational Site
Middelburg, 1050
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6014
GSK Investigational Site
Pretoria, Gauteng, 0181
GSK Investigational Site
Pretoria, 0001
GSK Investigational Site
Pretoria, 0002
GSK Investigational Site
Somerset West, 7130
GSK Investigational Site
Soweto, 2013
GSK Investigational Site
Thabazimbi
GSK Investigational Site
Welkom, 9460

Other trials in South Africa

Italy21 sites

GSK Investigational Site
Arenzano, Liguria, 16011
GSK Investigational Site
Bergamo, Lombardy, 24128
GSK Investigational Site
Brescia, 25123
GSK Investigational Site
Catania, Sicily, 95125
GSK Investigational Site
Florence, Tuscany, 50134
GSK Investigational Site
Messina, 98123
GSK Investigational Site
Milan, Lombardy, 20129
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Milan, Lombardy, 20162
GSK Investigational Site
Milan, 20122
GSK Investigational Site
Milan, 20142
GSK Investigational Site
Milan, 20157
GSK Investigational Site
Monza, 20052
GSK Investigational Site
Palermo, Sicily, 90146
GSK Investigational Site
Parma, Emilia-Romagna, 43125
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Roma, 00168
GSK Investigational Site
Rome, Lazio, 00135
GSK Investigational Site
Rome, Lazio, 00157
GSK Investigational Site
Rome, Lazio, 00165
GSK Investigational Site
Sesto San Giovanni, 20099

Other trials in Italy

United Kingdom17 sites

GSK Investigational Site
Barry, CF63 4AR
GSK Investigational Site
Bath, Somerset, BA2 1NH
GSK Investigational Site
Bedford, Bedfordshire, MK404AW
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
Chertsey, Surrey, KT16 0PZ
GSK Investigational Site
Glasgow, G12 0YN
GSK Investigational Site
Kent, CT5 3QU
GSK Investigational Site
Leicester, LE2 7LX
GSK Investigational Site
Liverpool, Merseyside, L7 8XP
GSK Investigational Site
London, E2 9JX
GSK Investigational Site
London, E9 6SR
GSK Investigational Site
Manchester, Greater Manchester, M20 2RN
GSK Investigational Site
Merseyside, CH41 0DD
GSK Investigational Site
Penzance, TK19 7HX
GSK Investigational Site
Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Argentina15 sites

GSK Investigational Site
Buenos Aires, 1406
GSK Investigational Site
Buenos Aires, 1425
GSK Investigational Site
Buenos Aires, 1602
GSK Investigational Site
Buenos Aires, C1121ABE
GSK Investigational Site
Concepción del Uruguay, Entre Ríos Province, 3260
GSK Investigational Site
Derqui, Pilar, Buenos Aires, B1629AHJ
GSK Investigational Site
La Plata, B1902COS
GSK Investigational Site
Lanus, B1824KAJ
GSK Investigational Site
Mendoza, 5500
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ
GSK Investigational Site
Paraná, Entre Ríos Province, E3100BHK
GSK Investigational Site
Rosario, Santa Fe Province, S2000JKR
GSK Investigational Site
Rosario, S2000BRH
GSK Investigational Site
San Martín, Buenos Aires, 1650
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Hungary15 sites

GSK Investigational Site
Baja, 6500
GSK Investigational Site
Balassagyarmat, 2660
GSK Investigational Site
Budapest, 1089
GSK Investigational Site
Budapest, 1101
GSK Investigational Site
Budapest, 1117
GSK Investigational Site
Budapest, 1195
GSK Investigational Site
Budapest, 1221
GSK Investigational Site
Debrecen, 4026
GSK Investigational Site
Kaposvár, 7400
GSK Investigational Site
Komló, 7300
GSK Investigational Site
Mosonmagyaróvár, 9200
GSK Investigational Site
Nagykanizsa, 08800
GSK Investigational Site
Ráckeve, 2300
GSK Investigational Site
Siófok, 8600
GSK Investigational Site
Szolnok, 5000

Other trials in Hungary

Canada14 sites

GSK Investigational Site
Brampton, Ontario, L6T3J1
GSK Investigational Site
Edmonton, Alberta, T5A 4L8
GSK Investigational Site
Edmonton, Alberta, T5X 3N5
GSK Investigational Site
Fort Erie, Ontario, L2A 1X3
GSK Investigational Site
Grimsby, Ontario, L3M 1P3
GSK Investigational Site
Kingston, Ontario, K7L 2V6
GSK Investigational Site
Mississauga, Ontario, L4T 4J2
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8
GSK Investigational Site
Oshawa, Ontario, L1H 7K4
GSK Investigational Site
Surrey, British Columbia, V35 2N6
GSK Investigational Site
Surrey, British Columbia, V4H 2H9
GSK Investigational Site
Toronto, Ontario, M5T 3A9
GSK Investigational Site
Victoria, British Columbia, V8V3N7
GSK Investigational Site
Windsor, Ontario, N8X 2G1

Other trials in Canada

Czechia13 sites

GSK Investigational Site
Havlíčkův Brod, 580 01
GSK Investigational Site
Hlučín, 748 01
GSK Investigational Site
Jaroměř, 551 01
GSK Investigational Site
Kyjov, 697 33
GSK Investigational Site
Pilsen, 301 00
GSK Investigational Site
Pilsen, 323 00
GSK Investigational Site
Prague, 110 00
GSK Investigational Site
Prague, 140 00
GSK Investigational Site
Prague, 158 00
GSK Investigational Site
Prague, 163 00
GSK Investigational Site
Prague, 169 00
GSK Investigational Site
Svitavy, 568 25
GSK Investigational Site
Třemošná, 330 11

Other trials in Czechia

Lithuania12 sites

GSK Investigational Site
Kaunas, LT-47144
GSK Investigational Site
Kaunas, LT-49456
GSK Investigational Site
Kaunas, LT-50009
GSK Investigational Site
Kaunas, LT-50128
GSK Investigational Site
Klaipėda, LT-92288
GSK Investigational Site
Šiauliai, LT-76231
GSK Investigational Site
Utena, LT-28151
GSK Investigational Site
Vilnius, LT -10207
GSK Investigational Site
Vilnius, LT-01117
GSK Investigational Site
Vilnius, LT-04338
GSK Investigational Site
Vilnius, LT-08406
GSK Investigational Site
Vilnius, LT-08661

Other trials in Lithuania

Bulgaria11 sites

GSK Investigational Site
Blagoevgrad, 2700
GSK Investigational Site
Pazardzhik, 4400
GSK Investigational Site
Plovdiv, 4000
GSK Investigational Site
Sliven, 8800
GSK Investigational Site
Sofia, 1000
GSK Investigational Site
Sofia, 1463
GSK Investigational Site
Sofia, 1606
GSK Investigational Site
Troyan Municipality, 5600
GSK Investigational Site
Varna, 9000
GSK Investigational Site
Veliko Tarnovo, 5000
GSK Investigational Site
Vidin, 3700

Other trials in Bulgaria

Indonesia11 sites

GSK Investigational Site
Denpasar, 80114
GSK Investigational Site
Depok Timur, 16411
GSK Investigational Site
Jakarta, 10430
GSK Investigational Site
Jakarta, 12430
GSK Investigational Site
Jakarta, 13230
GSK Investigational Site
Jakarta, 13630
GSK Investigational Site
Malang, 65100
GSK Investigational Site
Medan, 20111
GSK Investigational Site
Palembang, 30126
GSK Investigational Site
Semarang, 50242
GSK Investigational Site
Surakarta, 57126

Other trials in Indonesia

Australia10 sites

GSK Investigational Site
Auchenflower, Queensland, 4066
GSK Investigational Site
Bedford Park, South Australia, 5042
GSK Investigational Site
Broadmeadow, New South Wales, 2292
GSK Investigational Site
Clayton, Victoria, 3168
GSK Investigational Site
Parkville, 3052
GSK Investigational Site
Randwick, New South Wales, 2031
GSK Investigational Site
Redcliffe, Queensland, 4020
GSK Investigational Site
Subiaco, Western Australia, 6008
GSK Investigational Site
Westmead, New South Wales, 2145
GSK Investigational Site
Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea10 sites

GSK Investigational Site
Bucheon-si, 420-717
GSK Investigational Site
Bucheon-si, 420-767
GSK Investigational Site
Busan, 602-715
GSK Investigational Site
Chuncheon, 200-722
GSK Investigational Site
Gwangju, 501-757
GSK Investigational Site
Incheon, 402-751
GSK Investigational Site
Incheon, 403-720
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 136-705
GSK Investigational Site
Seoul, 137-701

Other trials in South Korea

Taiwan9 sites

GSK Investigational Site
Kaohsiung City, 824
GSK Investigational Site
Kaohsiung City, 833
GSK Investigational Site
Keelung, 20401
GSK Investigational Site
Koahsiung, 81346
GSK Investigational Site
Putzu, 613
GSK Investigational Site
Taipei, 106
GSK Investigational Site
Taipei, 115
GSK Investigational Site
Taipei, 220
GSK Investigational Site
Taipei

Other trials in Taiwan

Belgium7 sites

GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Jambes, 5100
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Montigny-le-Tilleul, 6110
GSK Investigational Site
Natoye, 5360

Other trials in Belgium

Mexico7 sites

GSK Investigational Site
Aguascalientes, Ags, Aguascalientes, 20127
GSK Investigational Site
Chihuahua City, 31020
GSK Investigational Site
Guadalajara, Jalisco, 44280
GSK Investigational Site
Huixquilucan, 52763
GSK Investigational Site
Monterrey, 64710
GSK Investigational Site
Monterrey, 64718
GSK Investigational Site
Zapopan, 45128

Other trials in Mexico

Chile6 sites

GSK Investigational Site
Santiago, 7560994
GSK Investigational Site
Temuco, Región de La Araucania, 4800798
GSK Investigational Site
Valdivia, 5090146
GSK Investigational Site
Valparaíso, Valparaiso, 2341131
GSK Investigational Site
Viña del Mar, 2570017.
GSK Investigational Site
Viña del Mar, 2570017

Other trials in Chile

Philippines6 sites

GSK Investigational Site
Dasmariñas, Cavite, 4114
GSK Investigational Site
Davao City, 8000
GSK Investigational Site
Las Piñas, 1470
GSK Investigational Site
Los Baños, 4030
GSK Investigational Site
Pulilan, 3005
GSK Investigational Site
Quezon City, 1100

Other trials in Philippines

Slovakia6 sites

GSK Investigational Site
Košice, 040 01
GSK Investigational Site
Kráľovský Chlmec, 077 01
GSK Investigational Site
Levice, 934 01
GSK Investigational Site
Martin, 036 59
GSK Investigational Site
Štúrovo, 943 11
GSK Investigational Site
Trnava, 917 01

Other trials in Slovakia

Austria5 sites

GSK Investigational Site
Feldkirch, 6800
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Vienna, 1230
GSK Investigational Site
Vienna, A-1030
GSK Investigational Site
Wels, 4600

Other trials in Austria

Latvia5 sites

GSK Investigational Site
Kuldīga, LV - 3301
GSK Investigational Site
Riga, LV 1003
GSK Investigational Site
Riga, LV-1004
GSK Investigational Site
Riga, LV1038
GSK Investigational Site
Tukums, LV - 3101

Other trials in Latvia

Malaysia5 sites

GSK Investigational Site
Alor Star, 05460
GSK Investigational Site
Kota Bharu, 15886
GSK Investigational Site
Kuala Pilah, 72000
GSK Investigational Site
Kuala Selangor, 68100
GSK Investigational Site
Sungai Buloh, 47000

Other trials in Malaysia

Croatia4 sites

GSK Investigational Site
Čakovec, 40000
GSK Investigational Site
Senj, 53270
GSK Investigational Site
Zadar, 23000
GSK Investigational Site
Zagreb, 10000

Other trials in Croatia

Peru4 sites

GSK Investigational Site
Lima, L 33
GSK Investigational Site
Lima, Lima 18
GSK Investigational Site
Lima, Lima 1
GSK Investigational Site
San Borja, Lima, L36

Other trials in Peru

Romania3 sites

GSK Investigational Site
Brasov, 500074
GSK Investigational Site
Cluj-Napoca, 400371
GSK Investigational Site
Sibiu, 550166

Other trials in Romania

Colombia2 sites

GSK Investigational Site
Bogotá
GSK Investigational Site
Bucaramanga

Other trials in Colombia

Denmark2 sites

GSK Investigational Site
Copenhagen, 2400
GSK Investigational Site
Rosklide, DK-4000

Other trials in Denmark

Serbia2 sites

GSK Investigational Site
Belgrade, 11000
GSK Investigational Site
Belgrade, 11080

Other trials in Serbia

About this study

Official title: SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

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 January of 2016. This is the final update, as this study is complete.

Conditions: Asthma
Being tested: ADVAIR 100/50mcg, ADVAIR 250/50mcg, ADVAIR 500/50mcg, FLOVENT 100mcg, FLOVENT 250mcg
Keywords: ADVAIR, Asthma, safety, FLOVENT
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
ADVAIR 500/50mcgDrug
Also called FSC 500/50
fluticasone propionate/salmeterol combination (500/50mcg) 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
FLOVENT 500mcgDrug
Also called FP 500
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months

Study groups in NCT01475721
Study group	Role	What they receive
ADVAIR 100/50mcg	Experimental	experimental drug Receives: Drug: ADVAIR 100/50mcg
ADVAIR 250/50mcg	Experimental	experimental drug Receives: Drug: ADVAIR 250/50mcg
ADVAIR 500/50mcg	Experimental	experimental drug Receives: Drug: ADVAIR 500/50mcg
FLOVENT 100mcg	Active comparator	active comparator Receives: Drug: FLOVENT 100mcg
FLOVENT 250mcg	Active comparator	active comparator Receives: Drug: FLOVENT 250mcg
FLOVENT 500mcg	Active comparator	active comparator Receives: Drug: FLOVENT 500mcg

What is being measured

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

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. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
Measured: From Day 1 up to 26 weeks
Number of Participants Experiencing at Least One Asthma Exacerbation
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Measured: From Day 1 up to 26 weeks

Secondary outcomes (3)

Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and 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.
Measured: From Day 1 up to 26 weeks
Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Measured: From Day 1 up to 26 weeks
Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.
Measured: From Day 1 up to 26 weeks

Timeline

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

18 Nov 201123 Jun 2015

First posted21 Nov 2011 (estimated)
Study start18 Nov 2011
Primary completion23 Jun 2015
Study completion23 Jun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 11,751 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01475721
Sponsor's protocol ID: 115359
Acronym: AUSTRI
Status last verified: Aug 2018
First submitted: 17 Nov 2011
Last updated: 6 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
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

Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162
Busse W, Stempel D, Aggarwal B, Boucot I, Forth R, Raphiou I, Rabe KF, Reddel HK. Insights from the AUSTRI study on reliever use before and after asthma exacerbations. J Allergy Clin Immunol Pract. 2022 Jul;10(7):1916-1918.e2. doi: 10.1016/j.jaip.2022.03.029. Epub 2022 Apr 9. No abstract available.
PubMed 35413473
Stempel DA, Raphiou IH, Kral KM, Yeakey AM, Emmett AH, Prazma CM, Buaron KS, Pascoe SJ; AUSTRI Investigators. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med. 2016 May 12;374(19):1822-30. doi: 10.1056/NEJMoa1511049. Epub 2016 Mar 6.
PubMed 26949137

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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Questions to ask the study team

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma
ClinicalTrials.gov ID: NCT01475721
Acronym / sponsor ID: AUSTRI / 115359
Conditions: Asthma
Keywords: ADVAIR, Asthma, safety, FLOVENT
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 11,751 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 18 Nov 2011 (actual)
Primary completion: 23 Jun 2015 (actual)
Study completion: 23 Jun 2015 (actual)
First posted: 21 Nov 2011 (estimated)
Results: Posted 14 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
ADVAIR 100/50mcg	Experimental	Drug: ADVAIR 100/50mcgexperimental drug
ADVAIR 250/50mcg	Experimental	Drug: ADVAIR 250/50mcgexperimental drug
ADVAIR 500/50mcg	Experimental	Drug: ADVAIR 500/50mcgexperimental drug
FLOVENT 100mcg	Active comparator	Drug: FLOVENT 100mcgactive comparator
FLOVENT 250mcg	Active comparator	Drug: FLOVENT 250mcgactive comparator
FLOVENT 500mcg	Active comparator	Drug: FLOVENT 500mcgactive comparator

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Provided consent to participate in the study
Male or female, 12 years of age and older
Clinical diagnosis of asthma for at least 1 year prior to the randomization
Clinic PEF of greater than or equal to 50% of predicted normal value
Subject must be appropriately using one of the treatments for asthma listed in the protocol

Key exclusion criteria (11 listed)

History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
Concurrent respiratory disease other than asthma
Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
Presence of a bacterial or viral respiratory infection that is not resolved at randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ADVAIR 100/50mcgAlso: FSC 100/50fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months	Drug	ADVAIR 100/50mcg
ADVAIR 250/50mcgAlso: FSC 250/50fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months	Drug	ADVAIR 250/50mcg
ADVAIR 500/50mcgAlso: FSC 500/50fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months	Drug	ADVAIR 500/50mcg
FLOVENT 100mcgAlso: FP 100fluticasone propionate (100) twice daily (AM and PM) for 6 months	Drug	FLOVENT 100mcg
FLOVENT 250mcgAlso: FP 250fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months	Drug	FLOVENT 250mcg
FLOVENT 500mcgAlso: FP 500fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months	Drug	FLOVENT 500mcg

Primary outcome

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 26 weeks
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. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
Number of Participants Experiencing at Least One Asthma Exacerbation
Time frame: From Day 1 up to 26 weeks
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.

3 secondary outcomes

Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
Time frame: From Day 1 up to 26 weeks
Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
Time frame: From Day 1 up to 26 weeks
Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
Time frame: From Day 1 up to 26 weeks

Results and safety

Results posted to the registry on 14 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluticasone Propionate/Salmeterol Combination (FSC)	5,834	5,823
Fluticasone Propionate (FP)	5,845	5,831

Primary outcome: 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 26 weeks. Number. Unit: Participants

Measure	Fluticasone Propionate/Salmeterol Combination (FSC) n = 5834	Fluticasone Propionate (FP) n = 5845
Value	34	33

Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Hazard Ratio (HR): 1.029 (95% CI 0.638 to 1.662), p = 0.003, Regression, Cox

Population analysed: Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug.

Primary outcome: Number of Participants Experiencing at Least One Asthma Exacerbation

Time frame: From Day 1 up to 26 weeks. Number. Unit: Participants

Measure	Fluticasone Propionate/Salmeterol Combination (FSC) n = 5834	Fluticasone Propionate (FP) n = 5845
Value	480	597

Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Hazard Ratio (HR): 0.834 (95% CI 0.630 to 1.103), p = 0.203, Regression, Cox
Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Hazard Ratio (HR): 0.839 (95% CI 0.645 to 1.090), p = 0.188, Regression, Cox
Fluticasone Propionate/Salmeterol Combination (FSC) vs Fluticasone Propionate (FP): Hazard Ratio (HR): 0.764 (95% CI 0.645 to 0.905), p = 0.002, Regression, Cox

Population analysed: Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluticasone Propionate/Salmeterol Combination (FSC)	134 of 5,834 (2.3%)	46 of 5,834 (0.8%)	Not reported
Fluticasone Propionate (FP)	125 of 5,845 (2.1%)	75 of 5,845 (1.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Derived from this study: PubMed 35413473Busse W, Stempel D, Aggarwal B, Boucot I, Forth R, Raphiou I, Rabe KF, Reddel HK. Insights from the AUSTRI study on reliever use before and after asthma exacerbations. J Allergy Clin Immunol Pract. 2022 Jul;10(7):1916-1918.e2. doi: 10.1016/j.jaip.2022.03.029. Epub 2022 Apr 9. No abstract available.
Derived from this study: PubMed 26949137Stempel DA, Raphiou IH, Kral KM, Yeakey AM, Emmett AH, Prazma CM, Buaron KS, Pascoe SJ; AUSTRI Investigators. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med. 2016 May 12;374(19):1822-30. doi: 10.1056/NEJMoa1511049. Epub 2016 Mar 6.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

808 sites in 33 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ADVAIR 100/50mcg, ADVAIR 250/50mcg and ADVAIR 500/50mcg in people with Asthma, run by GlaxoSmithKline at 808 sites in 33 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 9 inclusion and 11 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 808 sites in United States, Germany, Poland, Russia, Ukraine and 28 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 14 Jan 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 26 weeks). 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 NCT01475721, which also lists 3 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.