Steroids In Eosinophil Negative Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:8/17/2018
Start Date:July 2014
End Date:May 2018

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Because approximately half of all mild-moderately-severe asthma is persistently
non-eosinophilic, it is important to determine prospectively if patients who are persistently
non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to
patients who are not persistently non-eosinophilic.

SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover
study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled
corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be
compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).

Inclusion Criteria:

- Physician-diagnosed asthma for at least previous 12 months.

- Able to perform reproducible spirometry.

- Baseline FEV1≥70% of predicted.

- Asthma confirmed either by:

- Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR

- Methacholine PC20 ≤ 16 mg/ml

- At least 1 of the following indications for chronic controller therapy:

- Asthma Symptoms > 2 days/week OR

- Nocturnal Asthma Symptoms > 2 nights/month OR

- Short-acting beta-agonist use for symptom control > 2 days/week

- For participants ≥18 years of age: Ability to provide informed consent. For
participants under 18 years of age: Ability to provide verbal or written assent and
ability of parent to provide informed consent.

- Willingness, if female and able to conceive, to utilize one medically-acceptable form
of contraception.

Exclusion Criteria:

- Chronic inhaled or oral corticosteroid therapy.

- Use of inhaled or oral corticosteroid therapy within 6 weeks.

- New allergen immunotherapy within the past 3 months or anticipated changes to an
ongoing immunotherapy regimen.

- Use of omalizumab within 3 months.

- History of:

- bladder-neck obstruction, urinary retention or benign prostatic hyperplasia

- narrow angle glaucoma

- significant cardiovascular disorders and arrhythmias

- life-threatening asthma requiring treatment with intubation or mechanical
ventilation within the past 5 years

- Respiratory tract infection within past 6 weeks.

- History of smoking within the past 1 year, or > 10 pack-years total if ≥ 18 years of
age, or > 5 pack-years total if < 18 years of age.

- Chronic diseases or medical conditions (other than asthma) that could put the
participant at risk by participation, e.g. chronic diseases of the lung (other than
asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
We found this trial at
25
sites
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Cleveland, OH
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Boston, Massachusetts 02115
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Chicago, IL
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Durham, North Carolina 27710
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Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Orlando, Florida 32806
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Raleigh, North Carolina 27607
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63110
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San Francisco, California 94143
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San Francisco, California 94143
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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