A Clinical Trial for CTD-ILD Treatment
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ClinicalTrials.gov Identifier: NCT01424033 |
Recruitment Status
:
Terminated
(Departure of study team)
First Posted
: August 26, 2011
Results First Posted
: February 12, 2016
Last Update Posted
: April 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Interstitial Lung Disease Connective Tissue Disease | Drug: N-Acetylcysteine | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial of Oral Medication for CTD-ILD Treatment |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: N-Acetylcysteine
This is an open label trial, all patient will be entered into one treatment arm.
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Drug: N-Acetylcysteine
600mg by mouth, three times daily for 12 months
Other Names:
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- Pulmonary Function Tests [ Time Frame: Every 3 months ]Not recorded. Study terminated due to departure of PI.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424033
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Responsible Party: | Kristine Phillips, M.D., University of Michigan |
ClinicalTrials.gov Identifier: | NCT01424033 History of Changes |
Other Study ID Numbers: |
HUM00049434 |
First Posted: | August 26, 2011 Key Record Dates |
Results First Posted: | February 12, 2016 |
Last Update Posted: | April 6, 2017 |
Last Verified: | February 2017 |
Keywords provided by Kristine Phillips, 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:
Lung Diseases Lung Diseases, Interstitial Connective Tissue Diseases Respiratory Tract Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents |
Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |