NCT03581084: ICON

Inpatient Clinical Trial of NAC

Terminated Phase 4 Results posted Last updated 26 October 2021

What this trial tests

Phase 4 trial testing N-acetylcysteine in Asthma in 1 participant. Terminated before completion.

Timeline

6 July 2018

Primary endpoint
13 July 2018

6 October 2018

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	6 July 2018
Primary completion	13 July 2018
Estimated completion	6 October 2018
Sites	1 location across United States

Drugs / interventions tested

• N-acetylcysteine — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 80, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Forced Expiratory Volume in One Second (FEV1) Measurement Primary · end of the one week treatment period

Post-treatment FEV1 is reported. FEV1 is measured via spirometry.

Group	Value	95% CI
N-acetylcysteine	0.86

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

N-acetylcysteine

Serious: 1/1 (100%)

Deaths: 0/1

Serious adverse events (1 terms)

Reaction	System	N-acetylcysteine
Angina	Cardiac disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	N-acetylcysteine
Headache	General disorders	—

Most-reported serious reactions: Angina.

Data from ClinicalTrials.gov NCT03581084 adverse events section.

Sponsor's own description

The purpose of this study is to determine the beneficial effect of n-acetylcysteine (NAC), an inhaled medication that breaks down mucus, on lung function. NAC is a medication approved by the US Food and Drug Administration (FDA) for the treatment of chronic diseases of the respiratory system, including asthma. With CT lung imaging, the investigators seek to identify a subgroup of patients with asthma with a 'mucus' profile. This is a single-arm study which means all participants will receive the same treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The assessment of efficient representation of drug features using deep learning for drug repositioning.
   Moridi M, Ghadirinia M, Sharifi-Zarchi A, Zare-Mirakabad F. · · 2019 · cited 8× · PMID 31726977 · DOI 10.1186/s12859-019-3165-y