Overview
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.
Description
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.
Eligibility
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/l 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
