Back to resultsA Clinical Trial for CTD-ILD Treatment
Primary Purpose
Interstitial Lung Disease, Connective Tissue Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-Acetylcysteine
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease focused on measuring Interstitial lung disease, Connective tissue disease, Scleroderma, Rheumatoid arthritis, Sjogren's syndrome, Mixed connective tissue disease, Dermatomyositis, Polymyositis, Systemic lupus erythematosis
Eligibility Criteria
Inclusion:
- 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:
- 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.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
N-Acetylcysteine
Arm Description
This is an open label trial, all patient will be entered into one treatment arm.
Outcomes
Primary Outcome Measures
Pulmonary Function Tests
Not recorded. Study terminated due to departure of PI.
Secondary Outcome Measures
Full Information
NCT ID
NCT01424033
First Posted
August 24, 2011
Last Updated
February 22, 2017
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01424033
Brief Title
A Clinical Trial for CTD-ILD Treatment
Official Title
Clinical Trial of Oral Medication for CTD-ILD Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Departure of study team
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Connective Tissue Disease
Keywords
Interstitial lung disease, Connective tissue disease, Scleroderma, Rheumatoid arthritis, Sjogren's syndrome, Mixed connective tissue disease, Dermatomyositis, Polymyositis, Systemic lupus erythematosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-Acetylcysteine
Arm Type
Experimental
Arm Description
This is an open label trial, all patient will be entered into one treatment arm.
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Other Intervention Name(s)
NAC, acetylcysteine
Intervention Description
600mg by mouth, three times daily for 12 months
Primary Outcome Measure Information:
Title
Pulmonary Function Tests
Description
Not recorded. Study terminated due to departure of PI.
Time Frame
Every 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
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:
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.
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial for CTD-ILD Treatment
We'll reach out to this number within 24 hrs