A Clinical Trial for CTD-ILD Treatment
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).
Full description
The investigators will assess tolerability and safety at scheduled intervals via standard of care physical exam findings, monitoring complete blood count, serum chemistry, and pulmonary function tests, along with patient reports of medication intolerance and change in symptoms of dyspnea.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion:
- Subject gives voluntary written informed consent to participate in the study.
- Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.
- Males and females age greater than 18 years at time of screening.
- Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.
Exclusion:
- History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.
- Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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