A Clinical Trial for CTD-ILD Treatment

Phase 2

Terminated

• Conditions: Interstitial Lung Disease; Connective Tissue Disease
• Interventions: Drug: N-Acetylcysteine

• Registration Number: NCT01424033
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Study Start: 2011-12
• Primary Completion: 2013-02
• Results First Submitted: 2016-01-14
• Results First Submitted QC: 2016-01-14
• Results First Posted: 2016-02-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N-Acetylcysteine	N-Acetylcysteine	This is an open label trial, all patient will be entered into one treatment arm.

Primary Outcome Measures

Name	Time	Method
Pulmonary Function Tests	Every 3 months	Not recorded. Study terminated due to departure of PI.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States