Inhaled NAC in Treatment of IPF

• Register: ClinicalTrials.gov
• Last refreshed on: 14 June 2021
• Main ID: NCT03720483
• Date of registration: 18/07/2018
• Prospective Registration: Yes
• Primary sponsor: University of Colorado, Denver
• Public title: Inhaled NAC in Treatment of IPF
• Scientific title: Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis
• Date of first enrolment: January 2022
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03720483
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Mark Steele, MD
• Affiliation: University of Colorado, Denver

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis (IPF)

Intervention(s)

Drug: Placebo then N-acetyl cysteine

Drug: N-acetyl cysteine then Placebo

Primary Outcome(s)

Changes in Pulmonary function - DLCO [Time Frame: Baseline, week 10, and week 18]

Changes in Pulmonary function - FVC [Time Frame: Baseline, week 10, and week 18]

Secondary ID(s)

17-1477

Source(s) of Monetary Support

Please refer to primary and secondary sponsors