Clinical Trial of NAC in Asthma
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Post-bronchodilator FEV1 (L)
研究概览
简要总结
This study evaluates 20% n-acetylcystine (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 7-day treatment period and placebo in the next 7-day treatment period; and the other half will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment period.
详细描述
n-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs.
Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like COPD. However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction.
This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to perform reproducible spirometry according to ATS criteria
- •Clinical history consistent with moderate to severe asthma for 1 year or greater.
- •Post-bronchodilator FEV1 <90% of predicted
- •Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of beclomethasone or greater and a second asthma controller therapy.
- •CT mucus score >3 (determined during the initial screening process, provided the prior two conditions are met)
- •Written informed consent obtained from participant and ability for participant to comply with the requirements of the study.
排除标准
- •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.
- •History of intolerance to study medications.
- •Current use of carbamazepine
- •Angina which includes a treatment plan with PRN nitroglycerin or nitrites
- •Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year smoking history
- •Current participation in an investigational drug trial Concurrent Medications
研究组 & 干预措施
20% n-acetylcystine (NAC)
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.
干预措施: n-acetylcystine (Drug)
0.9% saline
Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.
干预措施: 0.9% saline (Drug)
结局指标
主要结局
Change in Post-bronchodilator FEV1 (L)
时间窗: 7 days
This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.
次要结局
- Change CT Mucus Score(7 days)