TerminatedPhase 2/3

A Clinical Trial for CTD-ILD Treatment

Stopped: Departure of study team

United States5 participantsStarted 2011-12

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Pulmonary Function Tests

Timeframe: Every 3 months

Trial details

NCT IDNCT01424033

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-02

Results submitted2016-01-14

View on ClinicalTrials.gov More Interstitial Lung Disease trials