A Clinical Trial for CTD-ILD Treatment

NCT ID: NCT01424033

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

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.

Conditions

Interstitial Lung Disease; Connective Tissue Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

N-Acetylcysteine

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

Group Type: EXPERIMENTAL

N-Acetylcysteine

Intervention Type: DRUG

600mg by mouth, three times daily for 12 months

Interventions

N-Acetylcysteine

600mg by mouth, three times daily for 12 months

Intervention Type: DRUG

Other Intervention Names

NAC; acetylcysteine

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Kristine Phillips

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00049434

Identifier Type: -

Identifier Source: org_study_id