Cysteamine for Asthma

• Status: Completed
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Cysteamine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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