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NCT03720483 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design

Related Conditions & MeSH terms

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
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