A Clinical Trial for CTD-ILD Treatment
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Orthopedic, Pulmonary |
Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2011 |
End Date: | February 2018 |
Clinical Trial of Oral Medication for CTD-ILD Treatment
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).
N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung
disease (CTD-ILD).
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.
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.
Inclusion:
1. Subject gives voluntary written informed consent to participate in the study.
2. 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.
3. Males and females age greater than 18 years at time of screening.
4. 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:
1. History of severe chronic kidney disease defined as a glomerular filtration rate of
less than 30.
2. Hemoglobin concentration less than 70% of the lower limit of the normal range at time
of screening.
3. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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