Inhaled NAC in Treatment of IPF

Sponsor

University of Colorado, Denver (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03720483

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis (IPF)	Drug: N-acetyl cysteine then Placebo Drug: Placebo then N-acetyl cysteine	Phase 1/Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: N-acetyl cysteine then placebo This arm will receive NAC followed by placebo	Drug: N-acetyl cysteine then Placebo Subject will receive N-acetyl cysteine first followed by Placebo
Experimental: Placebo then N-acetyl cysteine This arm will receive placebo followed by NAC	Drug: Placebo then N-acetyl cysteine Subject will receive Placebo first followed by N-acetyl cysteine

Arm

Intervention/Treatment

Experimental: N-acetyl cysteine then placebo

This arm will receive NAC followed by placebo

Drug: N-acetyl cysteine then Placebo

Subject will receive N-acetyl cysteine first followed by Placebo

Experimental: Placebo then N-acetyl cysteine

This arm will receive placebo followed by NAC

Drug: Placebo then N-acetyl cysteine

Subject will receive Placebo first followed by N-acetyl cysteine

Outcome Measures

Primary Outcome Measures

Changes in Pulmonary function - FVC [Baseline, week 10, and week 18]
Measure changes in percent predicted FVC
Changes in Pulmonary function - DLCO [Baseline, week 10, and week 18]
Measure changes in percent predicted DLCO

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Mark Steele, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT03720483

Other Study ID Numbers:

17-1477

First Posted:

Oct 25, 2018

Last Update Posted:

Jun 8, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Fibrosis

Acetylcysteine

N-monoacetylcystine

Study Results

No Results Posted as of Jun 8, 2021