A Clinical Trial for CTD-ILD Treatment

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Interstitial Lung Disease; Connective Tissue Disease	Drug: N-Acetylcysteine	Phase 2; Phase 3

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 Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Pulmonary Function Tests [ Time Frame: Every 3 months ]
   Not recorded. Study terminated due to departure of PI.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Michigan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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