Clinical Trial: A Clinical Trial for CTD-ILD Treatment

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Clinical Trial of Oral Medication for CTD-ILD Treatment

Brief 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).

Detailed Summary: 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.
Sponsor: University of Michigan

Current Primary Outcome: Pulmonary Function Tests [ Time Frame: Every 3 months ]

Not recorded. Study terminated due to departure of PI.


Original Primary Outcome: Assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD). [ Time Frame: 12 months ]

We 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.


Current Secondary Outcome:

Original Secondary Outcome:

  • Evaluate the efficacy of NAC in patients with CTD-ILD. [ Time Frame: 12 months ]
    We will evaluate efficacious treatment by assessing pulmonary function tests and subjective symptoms reported on patient questionnaires before starting NAC and again after three, six, nine, and twelve months of treatment initiation.
  • Assess serum matrix metalloproteinase (MMP) levels as a potential biomarker. [ Time Frame: 12 months ]
    Previous studies have documented elevated MMP levels in fibrotic lung disease. This prospective cohort study in patients with CTD-ILD will evaluate whether serum MMP is associated with clinically meaningful changes, and evaluate if levels correlate with changes in physiology or biomarkers.


Information By: University of Michigan

Dates:
Date Received: August 24, 2011
Date Started: December 2011
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017