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Inhaled NAC in Treatment of IPF

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ClinicalTrials.gov Identifier: NCT03720483
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


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




Primary Outcome Measures :
  1. Changes in Pulmonary function - FVC [ Time Frame: Baseline, week 10, and week 18 ]
    Measure changes in percent predicted FVC

  2. Changes in Pulmonary function - DLCO [ Time Frame: Baseline, week 10, and week 18 ]
    Measure changes in percent predicted DLCO



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720483


Contacts
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Contact: Julie Powers Becker 303-724-6539 julie.powers@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Mark Steele, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03720483     History of Changes
Other Study ID Numbers: 17-1477
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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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

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes