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.



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:November 2011
End Date:June 2015

Use our guide to learn which trials are right for you!

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

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 fluticasone propionate alone.

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

Progress of Enrollment, Updated Annually: On November 18, 2011 the first study subject visit
occurred. As of the cut-off date for the NDA Annual Report, May 24, 2015, 11,751 subjects
have been randomized. The target enrolment was 11,664 subjects. The expected completion date
for accrual and the study is ahead of schedule. GSK conducted Last Subject Last Visit in
June 4, 2015. Next expected annual update: July 2016

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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.
We found this trial at
361
sites
Anaheim, California 92807
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Alexandria, Virginia 22304
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Anaheim, California 92807
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Arlington, Texas 76014
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheboro, North Carolina 27203
?
mi
from
Asheboro, NC
Click here to add this to my saved trials
Asheville, North Carolina 28803
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atco, New Jersey 08004
?
mi
from
Atco, NJ
Click here to add this to my saved trials
Athens, Alabama 35611
?
mi
from
Athens, AL
Click here to add this to my saved trials
Austell, Georgia 30106
?
mi
from
Austell, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Avon, Indiana 46123
?
mi
from
Avon, IN
Click here to add this to my saved trials
Bakerfield, California 93301
?
mi
from
Bakerfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Bell Vernon, Pennsylvania 15012
?
mi
from
Bell Vernon, PA
Click here to add this to my saved trials
Belle Vernon, Pennsylvania 15012
?
mi
from
Belle Vernon, PA
Click here to add this to my saved trials
Belle Vernon, Pennsylvania 15012
?
mi
from
Belle Vernon, PA
Click here to add this to my saved trials
Bellevue, Nebraska 68123
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Bellingham, Washington 98225
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
Bensalem, Pennsylvania 19020
?
mi
from
Bensalem, PA
Click here to add this to my saved trials
Bensalem, Pennsylvania 19020
?
mi
from
Bensalem, PA
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
Boynton Beach, Florida 33472
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Brick, New Jersey 08723
?
mi
from
Brick, NJ
Click here to add this to my saved trials
Bronx, New York 10461
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Brooklyn, New York 11215
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brownsburg, Indiana 46112
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
Buckley, Michigan 49620
?
mi
from
Buckley, MI
Click here to add this to my saved trials
Calabash, North Carolina 28467
?
mi
from
Calabash, NC
Click here to add this to my saved trials
Carnegie, Pennsylvania 15106
?
mi
from
Carnegie, PA
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Centerville, Ohio 45459
?
mi
from
Centerville, OH
Click here to add this to my saved trials
Champaign, Illinois 61820
?
mi
from
Champaign, IL
Click here to add this to my saved trials
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chaska, Minnesota 55318
?
mi
from
Chaska, MN
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chelsea, Michigan 48118
?
mi
from
Chelsea, MI
Click here to add this to my saved trials
Chesterfield, Michigan 48047
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33759
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clearwater, Florida 33759
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Clyde, North Carolina 28721
?
mi
from
Clyde, NC
Click here to add this to my saved trials
Cocoa, Florida 32927
?
mi
from
Cocoa, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Maryland 21044
?
mi
from
Columbia, MD
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43219
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Corning, New York 14830
?
mi
from
Corning, NY
Click here to add this to my saved trials
Corsicana, Texas 75110
?
mi
from
Corsicana, TX
Click here to add this to my saved trials
Council Bluffs, Iowa 51503
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
Covington, Louisiana 70433
?
mi
from
Covington, LA
Click here to add this to my saved trials
Crown Point, Indiana 46307
?
mi
from
Crown Point, IN
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Dayton, Ohio 45420
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45420
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Denver, Colorado 80206
?
mi
from
Denver, CO
Click here to add this to my saved trials
Derqui, Pilar, Buenos Aires
?
mi
from
Derqui, Pilar,
Click here to add this to my saved trials
Destin, Florida 32541
?
mi
from
Destin, FL
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Dinuba, California 93618
?
mi
from
Dinuba, CA
Click here to add this to my saved trials
Doral, Florida 33172
?
mi
from
Doral, FL
Click here to add this to my saved trials
Doral, Florida 33172
?
mi
from
Doral, FL
Click here to add this to my saved trials
Downington, Pennsylvania 19335
?
mi
from
Downington, PA
Click here to add this to my saved trials
Duncanville, Texas 75116
?
mi
from
Duncanville, TX
Click here to add this to my saved trials
East Greenwich, Rhode Island 02818
?
mi
from
East Greenwich, RI
Click here to add this to my saved trials
Edison, New Jersey
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Edison, New Jersey
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Elizabeth, New Jersey 07201
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
Elizabeth, New Jersey 07201
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
Endwell, New York 13760
?
mi
from
Endwell, NY
Click here to add this to my saved trials