Elucidation of Acid-Induced Pulmonary Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Lymphocyte Count
研究概览
简要总结
This study will evaluate how heartburn may lead to different types of inflammation in one's airways. Additionally, the study will determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by gastroesophageal reflux (GER).
详细描述
Currently, many Americans suffer from asthma. The exact mechanism by which airway inflammation leads to asthma symptoms has yet to be clearly explained. In previous studies, persons with asthma appear to have different types of inflammation in their lungs. The reasons for this difference remain a mystery. Allergy is known to play a role in bronchospasm. Other mechanisms have not been discovered.
It is known that asthma and heartburn are correlated. Studies have confirmed a direct relationship between cough and heartburn (Gastroesophageal reflux). Other researchers have determined that asthma is often worsened by GER. Determination of the exact relationship between these two entities remains unclear.
Heartburn may contribute to airway inflammation in asthmatics, resulting in different patterns of inflammation between those people with and without GER. In fact, adult-onset asthma may result primarily from longstanding heartburn. This has yet to be proven.
This study will evaluate how heartburn may lead to different types of inflammation in one's airways. Additionally, the goal of this study is to determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by GER.
A total of 30 subjects will be studied, randomized to twice daily lansoprazole or placebo. Study procedures are as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic cough consistent with bronchoreactivity
- •Gastroesophageal reflux
排除标准
- •Severe asthmatics who have been hospitalized within the last 6 months or who have required oral steroid use within the last 4 weeks
- •Severe coronary artery disease
- •Cigarette/cigar smoking within the last 6 months
- •Documented allergies affecting the respiratory system
- •Subjects with contraindications to pH/impedance probe
- •Septal deviation
- •Subjects with contraindications to bronchoscopy as outlined by the American Thoracic Society Guidelines
- •Anticoagulation
- •Incarcerated patients
- •Current oral steroid use (may suppress levels of inflammation)
- •Upper respiratory infection within the last 2 weeks
- •Ongoing acid suppression with a proton pump inhibitor, however, patients may be included if they have discontinued their proton pump inhibitor within the last 1 month with stable asthma symptoms as defined by stable utilization of inhaled steroids
研究组 & 干预措施
Lansoprazole therapy
Lansoprazole 30 mg orally twice daily
干预措施: lansoprazole (Drug)
Placebo
placebo orally twice daily
干预措施: placebo (Drug)
结局指标
主要结局
Change in Lymphocyte Count
时间窗: Baseline and 6 weeks
Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.
次要结局
- Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement(Baseline and 6 weeks)
研究者
Kathryn A. Peterson
md
University of Utah