Inhaled NAC in Treatment of IPF

• Status: Withdrawn
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Diagnosed by study team with expertise in IPF utilizing standard ATS/ERS definition of "probable" or "definite" IPF

• DLCO >50% predicted

• FVC >60% predicted

• FEV1/FVC > 0.7

Exclusion Criteria:

• History of bronchospasm (requiring treatment)

• Current acute exacerbation of their IPF disease

• Current smoker

• Supplemental O2 requirement > 4 liters/min via nasal cannula

• History of asthma, COPD, coronary artery disease, or cancer

• Currently using NAC, hypertonic saline, or DNase (dornase alfa) inhalation therapy