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Inhaled NAC in Treatment of IPF

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Treatments

Drug: Placebo then N-acetyl cysteine
Drug: N-acetyl cysteine then Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03720483
17-1477

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

0 participants in 2 patient groups

N-acetyl cysteine then placebo
Experimental group
Description:
This arm will receive NAC followed by placebo
Treatment:
Drug: N-acetyl cysteine then Placebo
Placebo then N-acetyl cysteine
Experimental group
Description:
This arm will receive placebo followed by NAC
Treatment:
Drug: Placebo then N-acetyl cysteine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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