Inhaled NAC in Treatment of IPF

Phase 1

Withdrawn

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: N-acetyl cysteine then Placebo; Drug: Placebo then N-acetyl cysteine

• Registration Number: NCT03720483
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

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.

NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-08
• Study Start: 2022-01
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
N-acetyl cysteine then placebo	N-acetyl cysteine then Placebo	This arm will receive NAC followed by placebo
Placebo then N-acetyl cysteine	Placebo then N-acetyl cysteine	This arm will receive placebo followed by NAC

Primary Outcome Measures

Name	Time	Method
Changes in Pulmonary function - DLCO	Baseline, week 10, and week 18	Measure changes in percent predicted DLCO
Changes in Pulmonary function - FVC	Baseline, week 10, and week 18	Measure changes in percent predicted FVC

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States