Cysteamine for Asthma

Completed · Phase 1 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to see if a medicine called Cysteamine, given along with standard asthma care, will improve asthma symptoms and lung function.

Key facts

Study ID

NCT03883984

Run by

Children's Hospital Medical Center, Cincinnati

People needed

60

Starts

2019-06-18

Expected to finish

2021-02-10

Last updated by the study team

2021-05-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• Age ≥ 18 years and ≤ 45 years
• Provision of written informed consent
• Asthma currently treated with moderate-high doses of Inhaled Corticosteroids (ICS) per the National Asthma Education and Prevention Program (NAEPP) guidelines by self-report
• Evidence of hypersensitivity to environmental allergens, with at least one of the following:
• Elevated serum IgE
• Positive allergy skin prick testing to at least 1 allergen.
• Evidence of allergic rhinitis by physical exam or by medical history.
• Peripheral blood eosinophils ≥150 cells/µl obtained at screening visit.
• Asthma Severity Score indicating Moderate to Severe Impairment based on EPR-3 classification guidelines
• > 1 utilization for treatment of asthma exacerbation including prescription of oral or intravenous steroids (urgent care, emergency department visit, or hospitalization for asthma) in the past 12 months
• Negative urine pregnancy test for females of child bearing potential and use of contraception throughout the study.

You may not qualify if…

• Diagnosis of chronic lung disease other than asthma
• Have received biologic therapy (e.g., anti-IgE, anti-IL-4, anti-IL-5) within 6 months of study entry.
• Diagnosis of chronic disease other than asthma requiring daily steroids or immunosuppressive agents
• History of a heart attack or severe chronic heart disease
• Current smoking or previous history within 1 year
• Transplant patient
• IBD, Crohn's
• History of ulcer, gastric esophageal reflux (GERD) or chronic peptic ulcer disease
• Pregnant or planning to become pregnant
• Breastfeeding
• History of severe allergic or anaphylactic reactions to medications
• Grade 2-4 Abnormal Laboratory Results (hemoglobin, WBC, lymphocytes, platelets, sodium, potassium, glucose, BUN, creatinine, calcium, albumin, total protein, alkaline phosphate, AST, ALT, and bilirubin), see table 7.4.1.2a and 7.4.1.2b.
• Grade 3-4 Abnormal Eosinophils and Neutrophils, see table 7.4.1.2a.
• Evidence of papilledema, or history of pseudotumor cerebri
• History of persistent headaches
• Allergic reaction to cysteamine or penicillamine
• Serious medical condition that, in the opinion of the Study Investigator, would interfere with the ability of the patient to complete the study

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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