Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Rate of exacerbations
研究概览
简要总结
The main objective of the study is to determine the effects of low-dose oral theophylline added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel, prospective study. Patient will be recruited during an hospitalisation due to COPD exacerbation and randomised at the time of discharge to receive theophylline 100 mg or placebo on top of combination therapy with inhaled corticosteroids and long-acting beta agonist. The rate of exacerbations will be determined every three months up to one year follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of them, the following information will be obtained:
- Number/severity of exacerbations or hospitalisation since last clinic visit
- Compliance and side effects
- Blood sample
- Plasma levels of theophylline
- Sputum (induced)
- MMRC
- SGRQ
- Forced spirometry + inspiratory capacity
- At the beginning and at the end of the study
- 6MWT
- BMI
- BODE
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
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Ability to understand study procedures and to comply with them for the entire length of the study.
- •Any gender. No contraception is required neither pregnancy expected in the range of age
- •Age > 45 years
- •Smoking history > 10 pack-years (current or ex-smokers)
- •Clinical diagnosis of COPD
- •Presence of severe airflow obstruction on forced spirometry (FEV1/FVC < 0.7 and post-BD FEV1 < 50% of reference value) staged as GOLD III or IV
- •Diagnosis of COPD exacerbation on discharge.
排除标准
- •Presence or history of other chronic respiratory diseases (asthma, bronchiectasis, TB lesions)
- •Heart failure
- •Pregnancy, or risk of pregnancy
- •Other inflammatory diseases
- •Previous treatment with theophylline
- •For drug studies: allergy/sensitivity to study drugs or their ingredients.
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Intervention
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
干预措施: theophylline (Drug)
Control
inhaled corticosteroids and long-acting beta agonist + Placebo
干预措施: placebo (Other)
结局指标
主要结局
Rate of exacerbations
时间窗: 1 year
Rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
次要结局
- Number of hospitalisation(1 year)
研究者
Borja Cosio
MD, PhD
Hospital Son Espases