Idiopathic Pulmonary Fibrosis (IPF)
Conditions
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.
Interventions
DRUGN-acetyl cysteine then Placebo
Subject will receive N-acetyl cysteine first followed by Placebo
DRUGPlacebo then N-acetyl cysteine
Subject will receive Placebo first followed by N-acetyl cysteine
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pulmonary function - FVC | Baseline, week 10, and week 18 | Measure changes in percent predicted FVC |
| Changes in Pulmonary function - DLCO | Baseline, week 10, and week 18 | Measure changes in percent predicted DLCO |
Countries
United States
Outcome results
None listed