The Effect of NAC on Lung Function and CT Mucus Score (NCT03822637) | Clinical Trial Compass
TerminatedPhase 4
The Effect of NAC on Lung Function and CT Mucus Score
Stopped: The study was terminated due to COVID restrictions and funding challenges. The study was then simplified and redesigned as the TEAM study (NCT06152653).
United States4 participantsStarted 2019-02-20
Plain-language summary
This study evaluates 20% n-acetylcysteine (NAC) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by CT imaging. The study is a crossover design, which means that half the study participants will get 20% NAC in the first 14-day treatment period and placebo in the next 14-day treatment period; and the other half will get placebo in the first 14-day treatment period and 20% NAC in the next 14-day treatment period.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female between the ages of 18 and 80 years of age at Visit 1
. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
. Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria
. Physiological evidence of airflow obstruction (FEV1 bronchodilator reversibility of ≥ 12% or hyperreactivity to methacholine reflected by a methacholine provocative concentration that results in a 20% fall in FEV1(PC20) ≤ 16 mg/mL)
. Clinical history of asthma per patient report or medical record
. Pre-bronchodilator FEV1 \> 35% predicted
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was testing N-acetylcysteine (NAC) for asthma but was terminated early — can you tell me why it was stopped, and what that means for whether NAC might still be a useful option for my asthma?
2Since the trial only ran for 2 weeks and measured lung function changes like FEV1, do we actually have enough data from this or similar studies to know whether NAC has any real benefit for asthma patients like me?
3The trial was in Phase 4, which means NAC is already approved for other uses — does that change what we know about its safety profile if it were considered as part of my asthma management?
4Given that this trial was terminated before completion, are there other active or completed studies on NAC or similar mucolytic treatments for asthma that might give us better evidence to guide my treatment decisions?
5Compared to the standard asthma treatments I might already be a candidate for, like inhaled corticosteroids or bronchodilators, how would you weigh the limited or incomplete evidence from this NAC trial when thinking about what's best for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Mean Forced Expiratory Volume in One Second (FEV1) Liters at 2 Weeks
Timeframe: Baseline and 2 Weeks
2
Percent Change From Baseline in Mean Forced Expiratory Volume in One Second (FEV1) Percent Predicted at 2 Weeks
. Post-bronchodilator FEV1 \> 40% but \< 90% predicted
. Asthma requiring treatment with inhaled corticosteroids (ICS) for 3 months or greater
Exclusion criteria
. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
. Smoking of tobacco or other recreational inhalants in last year and/or \>10 pack-year smoking history
. Adherence to study drug ≤ 70% after first treatment period
. Current participation in an investigational drug trial
. Other chronic pulmonary disorders, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways