NCT03720483

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
3.2 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

July 18, 2018

Last Update Submit

June 3, 2021

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (2)

  • Changes in Pulmonary function - FVC

    Measure changes in percent predicted FVC

    Baseline, week 10, and week 18

  • Changes in Pulmonary function - DLCO

    Measure changes in percent predicted DLCO

    Baseline, week 10, and week 18

Study Arms (2)

N-acetyl cysteine then placebo

EXPERIMENTAL

This arm will receive NAC followed by placebo

Drug: N-acetyl cysteine then Placebo

Placebo then N-acetyl cysteine

EXPERIMENTAL

This arm will receive placebo followed by NAC

Drug: Placebo then N-acetyl cysteine

Interventions

N-acetyl cysteine then PlaceboDRUG

Subject will receive N-acetyl cysteine first followed by Placebo

N-acetyl cysteine then placebo
Placebo then N-acetyl cysteineDRUG

Subject will receive Placebo first followed by N-acetyl cysteine

Placebo then N-acetyl cysteine

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mark Steele, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

October 25, 2018

Study Start

January 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)