A Clinical Trial for CTD-ILD Treatment

February 22, 2017 updated by: Kristine Phillips, University of Michigan

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function Tests
Time Frame: Every 3 months
Not recorded. Study terminated due to departure of PI.
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00049434

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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