Steroids In Eosinophil Negative Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02066298

Run by

Milton S. Hershey Medical Center

People needed

295

Starts

2014-07-01

Expected to finish

2018-05-01

Last updated by the study team

2019-05-29

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona College of Medicine — Tucson, Arizona, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• University of California at San Francisco — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Nemours Children's Clinic — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Ann and Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Rainbow Babies and Children's Hospital, Case Western Reserve University — Cleveland, Ohio, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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