A Clinical Trial for CTD-ILD Treatment (ENACT)

This study has been terminated.

(Departure of study team)

Sponsor:

Information provided by (Responsible Party):

Kristine Phillips, University of Michigan

ClinicalTrials.gov Identifier:

NCT01424033

First received: August 24, 2011

Last updated: January 14, 2016

Last verified: January 2016

History of Changes

Purpose

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	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:	Clinical Trial of Oral Medication for CTD-ILD Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Sjögren syndrome pulmonary alveolar microlithiasis rheumatoid arthritis

MedlinePlus related topics: Connective Tissue Disorders Interstitial Lung Diseases Lung Diseases

Drug Information available for: Acetylcysteine

Genetic and Rare Diseases Information Center resources: Systemic Scleroderma Polymyositis Dermatomyositis Mixed Connective Tissue Disease

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Pulmonary Function Tests [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]


Enrollment:	5
Study Start Date:	December 2011
Estimated Study Completion Date:	February 2018
Primary Completion Date:	February 2013 (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

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.

Eligibility


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

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.

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

Locations


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

Sponsors and Collaborators

University of Michigan

Investigators


Study Director:	Kristine Phillips, MD	University of Michigan

More Information


Responsible Party:	Kristine Phillips, M.D., University of Michigan
ClinicalTrials.gov Identifier:	NCT01424033 History of Changes
Other Study ID Numbers:	HUM00049434
Study First Received:	August 24, 2011
Results First Received:	January 14, 2016
Last Updated:	January 14, 2016
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:


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

ClinicalTrials.gov processed this record on September 23, 2016

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