Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 28, 2015
End Date:July 10, 2017

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A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma

Prospective, single-arm, longitudinal, international, multicenter study in a real-world
cohort of adult severe asthma participants being conducted to assess the relationships
between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.


Inclusion Criteria:

- Asthma diagnosed by a respiratory physician greater than or equal to (>/=) 12 months
prior to study enrolment

- Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1

- Documented bronchodilator response defined as >/=12% relative improvement in FEV1
after bronchodilator administration or a positive methacholine bronchial challenge
test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (<) 8
milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline

- Current treatment with a total daily dose of >/= 500 micrograms (mcg) of fluticasone
propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the
following controller medications: long-acting Beta-agonist (LABA), leukotriene
receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline
or oral corticosteroids, with a continued duration of three months prior to
baseline/Visit 1

Exclusion Criteria:

- Acute or chronic parasitic, bacterial, fungal or viral infections that required, or
currently require, hospitalization or antimicrobial treatment during the last four
weeks prior to participant eligibility

- Acute asthma exacerbation or any other medical event treated with increased doses of
oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six
weeks prior to study

- Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease,
idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension,
tuberculosis) requiring treatment within 12 months prior to baseline/Visit 1

- Ex-smokers with >/=10 pack-year smoking history

- Prior treatment with bronchial thermoplasty

- Participation in any clinical trial of an investigational agent or procedure within
six months prior to baseline/Visit 1 or during the study

- Pregnancy prior to participation or during the study
We found this trial at
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Albany, GA
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Birmingham, Alabama 35209
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Blue Bell, Pennsylvania 19422
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808 Lenniksebaan
Bruxelles, 1070
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2955 Ivy Road
Charlottesville, Virginia 22903
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Commack, New York 11725
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Coral Gables, Florida 33134
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Fairfax, Virginia 22031
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mission Viejo, California 92691
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Mount Laurel, New Jersey 08054
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Murray, Utah 84107
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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North Logan, Utah 84341
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Papillion, Nebraska 68046
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Pittsburgh, Pennsylvania 15241
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Port Charlotte, Florida 33952
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Sacramento, California 95819
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San Antonio, Texas 78251
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San Diego, California 92108
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Seattle, Washington 98105
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Spokane, Washington 99204
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Tulsa, Oklahoma 74136
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Waterbury, Connecticut
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Wyomissing, Pennsylvania 19610
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