NCT00163527已完成3 期
A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,054
- 试验地点
- 24
- 主要终点
- change in forced expiratory volume in 1 second from baseline to final visit.
研究概览
简要总结
Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.
The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
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
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
- •The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
- •FEV1 between 60 and 90% predicted at visit 1
- •No change in asthma treatment within 4 weeks prior to visit 1
排除标准
- •Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
- •Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
- •A history of lower airway infection in the four weeks prior to visit 1
- •A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
- •Heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
- •Patients using >8 puffs/day relief medication regularly prior to visit 1
- •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- •A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
- •Patients with chronic heart failure class III or IV (New York Heart Association)
- •Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
- •A history of alcoholism or substance abuse within the 12 months prior to visit 1
- •Pregnancy or women of childbearing potential who are not using a reliable method of contraception
结局指标
主要结局
change in forced expiratory volume in 1 second from baseline to final visit.
次要结局
- area under the curves over the full 24-week trial period for the diary variables
- change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).
- change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
- number of exacerbations
- change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
- number of rescue free/symptom free days based on the diary card
- time to first exacerbation
研究者
研究点 (24)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)AsthmaNCT00163475AstraZeneca511
已完成
3 期
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)AsthmaNCT00073177AstraZeneca819
已完成
3 期
Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)COPDChronic Obstructive Pulmonary DiseaseNCT00062582AstraZeneca1,000
已完成
3 期
The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)Chronic Obstructive Pulmonary Disease, COPDNCT00108823AstraZeneca550
已完成
3 期
The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)AsthmaNCT00076076AstraZeneca822