A Clinical Trial for CTD-ILD Treatment

Interstitial Lung Disease Clinical Trial

— ENACT  

Official title:

Clinical Trial of Oral Medication for CTD-ILD Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01424033
• Other study ID #: HUM00049434
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 24, 2011
• Last updated: January 14, 2016
• Start date: December 2011
• Est. completion date: February 2018

Study information

• Verified date: January 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 2018
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Connective Tissue Disease
• Connective Tissue Diseases
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• N-Acetylcysteine
600mg by mouth, three times daily for 12 months

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Tests		Every 3 months	No