Inhaled NAC in Treatment of IPF

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis (IPF)

Intervention / Treatment
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* Drug: N-acetyl cysteine then Placebo
* Drug: Placebo then N-acetyl cysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetyl cysteine then placebo<br>This arm will receive NAC followed by placebo | Drug: N-acetyl cysteine then Placebo<br>* Subject will receive N-acetyl cysteine first followed by Placebo<br>|
| Experimental: Placebo then N-acetyl cysteine<br>This arm will receive placebo followed by NAC | Drug: Placebo then N-acetyl cysteine<br>* Subject will receive Placebo first followed by N-acetyl cysteine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |