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Evaluating N-Acetylcysteine in CTD-ILD Treatment (ENACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mona Trivedi, University of Michigan
ClinicalTrials.gov Identifier:
NCT01424033
First received: August 24, 2011
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

Specific Aim 1:

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).

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.

Specific Aim 2:

The second objective of this protocol is to evaluate the efficacy of NAC in patients with CTD-ILD.

The investigators 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.

Specific Aim 3:

The third objective of this protocol is to assess serum matrix metalloproteinase (MMP) levels as a potential biomarker.

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.


Condition Intervention Phase
Interstitial Lung Disease
Connective Tissue Disease
Drug: N-Acetylcysteine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing Safety and Tolerability of N-acetylcysteine Use in Interstitial Lung Disease Associated With Connective Tissue Diseases

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Evaluate the efficacy of NAC in patients with CTD-ILD. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-Acetylcysteine
This is an open label trial, all patient will be entered into one treatment arm.
Drug: N-Acetylcysteine
600mg by mouth, three times daily for 12 months
Other Names:
  • NAC
  • acetylcysteine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by high resolution 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.
  • Subject is able to return for assessments every three months for one year.
  • Pulmonary function studies completed within the last 12 weeks demonstrating FVC less than 90% of the predicted value.
  • An FVC decline of 5-15% between screening PFT and PFT prior to screening.

Exclusion Criteria:

  • History of severe chronic kidney disease defined as a GFR 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.
  • Concurrent use of nitroglycerin.
  • Significant comorbidities interfering with respiratory status, i.e., congestive heart failure, pulmonary hypertension, cancer, COPD.
  • High resolution computed tomography demonstrating a pulmonary disease other than interstitial lung disease as the predominant pulmonary abnormality.
  • Patients considered to have stable, fibrotic lung disease without active inflammation per the investigators.
  • History of noncompliance with recommended medical therapy, or is determined to be a poor study candidate by the investigators.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424033

Contacts
Contact: Mona Trivedi, M.D. 734-763-3110 monat@med.umich.edu
Contact: Kristine Phillips, M.D., Ph.D. 734-763-3110

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mona Trivedi, M.D.    734-763-3110    monat@med.umich.edu   
Principal Investigator: Mona Trivedi, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Mona Trivedi, M.D. University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Mona Trivedi, M.D., University of Michigan
ClinicalTrials.gov Identifier: NCT01424033     History of Changes
Other Study ID Numbers: HUM00049434
Study First Received: August 24, 2011
Last Updated: December 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Interstitial lung disease
Connective tissue disease
Scleroderma
Rheumatoid arthritis
Sjogren's syndrome
Mixed connective tissue disease
Dermatomyositis
Polymyositis
Systemic lupus erythematosis

Additional relevant MeSH terms:
Connective Tissue Diseases
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014