The Effects of Atorvastatin Treatment in COPD Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in CD45+ cells expression over study period
研究概览
简要总结
Rationale: Retrospective studies suggest that statins improve outcomes in COPD patients possibly as a result of an anti-inflammatory effect.
Objectives: To determine whether statins have an anti-inflammatory effect on the lungs of patients with COPD.
A controlled, parallel group study to compare the effects of Atorvastatin in comparison to placebo as an add-on treatment to Formoterol therapy in patients with mild to moderate COPD in group of 20 patients. All subjects will have spirometry, lung volumes, DLCO, SGRQ, 6MWD, serum lipids and hs-CRP measured before and after treatment. Bronchoscopy and transbronchial lung biopsy (TBB) will be carried out at baseline and after 12 weeks of treatment, and TBB specimens will be processed for histology, immunohistochemistry and microarray analysis.
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
- Single (Participant)
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
- •. Written informed consent must be obtained before any assessment is performed.
- •Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •Patients with moderate to very severe stable COPD (Stage II-IV) according to the GOLD guidelines.
- •Patients with a post-bronchodilator FEV1 < 80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at Visit
- •Current or ex-smokers who have a smoking history of at least 10 pack years
- •Exclusion criteria
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment.
- •Patients with a clinically significant abnormality at Visit
- •Patients with a clinically relevant laboratory abnormality at Visit 1
- •Patients with a history of malignancy of any organ system (including lung cancer).
- •Patients contraindicated for treatment with statins
- •Patients unable to perform acceptable spirometry and lung volumes procedures.
- •Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to Visit
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit
- •Patients requiring oxygen therapy (>15 hr/day) on a daily basis for chronic hypoxemia
- •Patients with any history of asthma or onset of symptoms prior to age 40 years.
- •Patients with concomitant pulmonary disease, (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).
- •Patients with primary bronchiectasis.
- •Patients with a diagnosis of α-1 anti-trypsin deficiency.
- •Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
- •Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
- •Patients receiving any medications in the class listed in Table 5.1
- •Use of other investigational drugs within 30 days prior to visit 1.
排除标准
- 未提供
研究组 & 干预措施
Atorvastatin
40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy.
干预措施: Atorvastatin (Drug)
Atorvastatin
40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy.
干预措施: Formoterol (Drug)
Lactose tablet
One tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy.
干预措施: Formoterol (Drug)
Lactose tablet
One tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy.
干预措施: Lactose tablet (Drug)
结局指标
主要结局
Change in CD45+ cells expression over study period
时间窗: 12 weeks
Change in CD45+ cells expression measured by immunohistochemistry in lung biopsy samples assessed before and after 12 weeks of treatment
Change in gene expression over study period
时间窗: 12 weeks
Change in gene expression measured in lung biopsy samples measured using microarrays before and after 12 weeks of treatment
次要结局
- Change in health related quality of life over study period(12 weeks)
- Change in 6-Minute Walk Distance over study period(12 weeks)
- Change in intimal-medial thickness over study period(12 weeks)
- Change in hs-CRP over study period(12 weeks)
- Change in total cholesterol, LDL and HDL-Cholesterol and triglycerides over study period(12 weeks)
研究者
Robert M. Mroz
Associate Professor
Medical University of Bialystok