An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma



Status:Terminated
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:10/14/2017
Start Date:November 2014
End Date:May 2015

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A Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 12 Weeks In Subjects With Persistent Moderate To Severe Asthma Who Remain Uncontrolled Despite Treatment With Inhaled Corticosteroids (Ics) And Long-acting Beta2 Agonists (Laba)

The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe
asthma when added to standard of care and during staged withdrawal of background therapy.

Study terminated on 7th April 2015. The termination was due to business reasons. No safety or
efficacy concerns contributed to the termination of the study

Inclusion Criteria:

- Subjects with a physician documented history or diagnosis of persistent asthma
(according to GINA, 2014 definition of asthma),

- Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.

- Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol
combination therapy, or budesonide/formoterol combination therapy or
mometasone/formoterol combination therapy.

- Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control
Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than
or equal to 3.0)

Exclusion Criteria:

- Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic
pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis,
Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis,
tuberculosis).

- Subjects who are current smokers.
We found this trial at
28
sites
Minneapolis, Minnesota 55402
625
mi
from 43215
Minneapolis, MN
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30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
354
mi
from 43215
Greenville, SC
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750 Highland Avenue
Madison, Wisconsin 53792
394
mi
from 43215
Madison, WI
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Baltimore, Maryland 21236
349
mi
from 43215
Baltimore, MD
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Bellevue, Nebraska 68123
679
mi
from 43215
Bellevue, NE
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Birmingham, Alabama 35209
495
mi
from 43215
Birmingham, AL
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Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
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Cincinnati, Ohio 45231
95
mi
from 43215
Cincinnati, OH
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Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
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1157
mi
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Denver, CO
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Fullerton, California 92835
1958
mi
from 43215
Fullerton, CA
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1025
mi
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Killeen, TX
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624
mi
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Little Rock, AR
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1983
mi
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Los Angeles, CA
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Los Angeles, California 90025
1972
mi
from 43215
Los Angeles, CA
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New Hyde Parkd, New York 11040
494
mi
from 43215
New Hyde Parkd, NY
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North Dartmouth, Massachusetts 02747
639
mi
from 43215
North Dartmouth, MA
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Phoenix, Arizona 85006
1660
mi
from 43215
Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
162
mi
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Pittsburgh, PA
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Riverside, California 92506
1929
mi
from 43215
Riverside, CA
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Rolling Hills Estates, California 66212
625
mi
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Rolling Hills Estates, CA
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San Diego, California 92120
1951
mi
from 43215
San Diego, CA
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394
mi
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St. Louis, MO
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St. Louis, Missouri 63108
397
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St. Louis, MO
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St. Louis, Missouri 63141
397
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St. Louis, MO
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821
mi
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Tampa, FL
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Winston-Salem, North Carolina 26157
306
mi
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Winston-Salem, NC
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Winter Park, Florida 32789
791
mi
from 43215
Winter Park, FL
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