A Clinical Trial for CTD-ILD Treatment

NCT01424033 | Terminated Phase 2 Results DMC

• 1 other identifier: HUM00049434
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function Tests

  Not recorded. Study terminated due to departure of PI.

  Every 3 months

Study Arms (1)

N-Acetylcysteine

EXPERIMENTAL

This is an open label trial, all patient will be entered into one treatment arm.

Drug: N-Acetylcysteine

Interventions

N-Acetylcysteine DRUG

600mg by mouth, three times daily for 12 months

Also known as: NAC, acetylcysteine

N-Acetylcysteine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Connective Tissue Diseases; Scleroderma, Diffuse; Arthritis, Rheumatoid; Sjogren's Syndrome; Mixed Connective Tissue Disease; Dermatomyositis; Polymyositis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Skin Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Five subjects were consented. Study was terminated prior to conclusion due to departure of PI.

Results Point of Contact

• Title: Jan Stevens
• Organization: University of Michigan

janstev@med.umich.edu

7349365566

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 26, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Last Updated: April 6, 2017
• Results First Posted: February 12, 2016

Record last verified: 2017-02

Locations

US (1)