Inhaled NAC in Treatment of IPF

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

Official title:

Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03720483
• Other study ID #: 17-1477
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 2022
• Est. completion date: December 2023

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Intervention

Drug:
• N-acetyl cysteine then Placebo
Subject will receive N-acetyl cysteine first followed by Placebo
• Placebo then N-acetyl cysteine
Subject will receive Placebo first followed by N-acetyl cysteine

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Pulmonary function - FVC	Measure changes in percent predicted FVC	Baseline, week 10, and week 18
Primary	Changes in Pulmonary function - DLCO	Measure changes in percent predicted DLCO	Baseline, week 10, and week 18