Cysteamine for Asthma

STATUS

Recruiting
participants needed

50
sponsor

Children's Hospital Medical Center, Cincinnati

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Updated on 20 September 2024

See if I qualify

corticosteroids

rhinitis

skin prick

allergen

eosinophil count

prick skin

pulmonary function test

skin prick test

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.

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.

Details

Condition	Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age	18years - 45years
Treatment	Cysteamine Bitartrate, Placebo Oral Tablet
Clinical Study Identifier	NCT03883984
Sponsor	Children's Hospital Medical Center, Cincinnati
Last Modified on	20 September 2024

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Eligibility		Yes	No	Not Sure
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

How to participate?

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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Cysteamine for Asthma