A Placebo-controlled Trial of Roflumilast (Daliresp) on Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.
研究概览
简要总结
The purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD. The investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, > 40 years of age
- •Clinical diagnosis of moderate to severe COPD as defined by the GOLD criteria:
- •Post-bronchodilator FEV1/FVC < 70% Post-bronchodilator FEV1 < 70% predicted
- •Cigarette consumption of 10 pack-years or more. Patients may be active smokers.
- •The presence of chronic cough and sputum production
- •Willingness to make return visits and telephone availability for the study duration
排除标准
- •A diagnosis of asthma as established by the study investigator on the basis of the recent American Thoracic Society/European Respiratory Society guidelines
- •Clinically significant bronchiectasis
- •Oxygen use >12 hours/day
- •Known sensitivity to roflumilast
- •Use of other methylxanthines within 1 month (theophylline)
- •Changes to current maintenance COPD therapy within one month
- •An acute illness requiring antibiotics and/or corticosteroids within the month prior to enrolment.
- •Immunosuppression
- •Solid organ transplant
- •Active malignancy
- •Systemic corticosteroid use ≥ prednisone 20mg / day
- •Other immunosuppressants
- •Terminal illness defined as anticipated survival <12 months
- •Severe comorbidities including uncontrolled angina, congestive heart failure, end-stage renal disease, liver failure, or other conditions that would preclude the patient from safely completing the required tests or the study.
研究组 & 干预措施
Placebo
The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.
干预措施: placebo (Drug)
Daliresp
The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
干预措施: roflumilast (Drug)
结局指标
主要结局
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.
时间窗: 1 month after baseline
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization
时间窗: 3 months after baseline
Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline
时间窗: baseline
次要结局
- Induced Sputum Neutrophil Count(3 months after baseline)
研究者
J Edwin Blalock
Professor
University of Alabama at Birmingham