Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2022-01-31
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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N-acetyl cysteine then placebo
This arm will receive NAC followed by placebo
N-acetyl cysteine then Placebo
Subject will receive N-acetyl cysteine first followed by Placebo
Placebo then N-acetyl cysteine
This arm will receive placebo followed by NAC
Placebo then N-acetyl cysteine
Subject will receive Placebo first followed by N-acetyl cysteine
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* DLCO \>50% predicted
* FVC \>60% predicted
* FEV1/FVC \> 0.7
Exclusion Criteria
* 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
40 Years
75 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Mark Steele, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Other Identifiers
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17-1477
Identifier Type: -
Identifier Source: org_study_id
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