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Inhaled NAC in Treatment of IPF

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
N-acetyl cysteine then Placebo
Placebo then N-acetyl cysteine
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

N-acetyl cysteine then placebo

Placebo then N-acetyl cysteine

Arm Description

This arm will receive NAC followed by placebo

This arm will receive placebo followed by NAC

Outcomes

Primary Outcome Measures

Changes in Pulmonary function - FVC
Measure changes in percent predicted FVC
Changes in Pulmonary function - DLCO
Measure changes in percent predicted DLCO

Secondary Outcome Measures

Full Information

First Posted
July 18, 2018
Last Updated
June 3, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03720483
Brief Title
Inhaled NAC in Treatment of IPF
Official Title
Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study encountered challenges during startup due to the COVID-19 epidemic and was withdrawn.
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis (IPF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetyl cysteine then placebo
Arm Type
Experimental
Arm Description
This arm will receive NAC followed by placebo
Arm Title
Placebo then N-acetyl cysteine
Arm Type
Experimental
Arm Description
This arm will receive placebo followed by NAC
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine then Placebo
Intervention Description
Subject will receive N-acetyl cysteine first followed by Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo then N-acetyl cysteine
Intervention Description
Subject will receive Placebo first followed by N-acetyl cysteine
Primary Outcome Measure Information:
Title
Changes in Pulmonary function - FVC
Description
Measure changes in percent predicted FVC
Time Frame
Baseline, week 10, and week 18
Title
Changes in Pulmonary function - DLCO
Description
Measure changes in percent predicted DLCO
Time Frame
Baseline, week 10, and week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Steele, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inhaled NAC in Treatment of IPF

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