Cysteamine for Asthma

Asthma affects 25.7 million people in the US. Many people report symptoms despite taking high-doses of inhaled asthma medications. This difficult-to-treat group accounts for more than 50% of asthma related healthcare visits and hospitalizations. 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.

This study is a double-blind, placebo-controlled, randomized trial of cysteamine. A placebo arm will be included to determine the comparative effectiveness of cysteamine in this population. Eligible participants will be assessed 1, 4 and 8 weeks post randomization and followed for an additional 4 weeks post treatment.

In order to enroll in this study, participants must be between the ages of 18-45 and have uncontrolled asthma.

This study will include 4 visits and weekly phone calls, and will be in the study for 3-4 months.

During the treatment period, participants will be placed in one of two treatment groups:

• Cysteamine
• Placebo

Participants will not be able to choose which group they are assigned. This assignment is random and by chance, much like flipping a coin. Participants will not know if they are receiving Cysteamine or placebo. Investigators will compare the study results between the participants of each group.

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