NCT00292838已完成4 期
Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Sputum eosinophils
研究概览
简要总结
To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sputum eosinophilia >3%
- •Adults age 18-70 years
- •History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
- •FEV1 ≥ 60% predicted
- •Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
- •Able to give written informed consent
排除标准
- •Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
- •Relevant seasonal allergen exposure within 4 weeks or within the course of the study
- •Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
- •Other respiratory diseases
- •Women who are pregnant or unwilling to use appropriate contraception during the study
- •Unable to withhold short-acting ß-agonist treatment for 6 hours before visit
结局指标
主要结局
Sputum eosinophils
次要结局
- Exhaled nitric oxide, FEV1, FEF25-75%
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
To Evaluate the Efficacy and Safety of Inhaled Corticosteroids Combined With Bronchodilators and Programmed Death-ligand 1 (PD-L1) Inhibitor Plus Platinum-based Chemotherapy in Patients With Advanced Lung Squamous Cell Carcinoma Complicated With Chronic Obstructive Pulmonary Disease (COPD)Lung Cancer Squamous CellCOPDNCT06772454Guangzhou Institute of Respiratory Disease60
已完成
2 期
Evaluation of Inhaled Treatment in SinusitisSinusitisNCT01907204Cliniques universitaires Saint-Luc- Université Catholique de Louvain50
已完成
3 期
Does inhaled corticosteroid predispose asthmatic patients to diabetes?Chronic lower respiratory diseases.AsthmaIRCT201605247411N2Ahvaz Jundishapur University of Medical Science28
进行中（未招募）
不适用
Effectiveness of inhaled corticosteroids in preschool children following hospital admission for acute dyspnea and wheeze - ICS@ADPDyspnea and wheeze in young children:Symptoms of dyspnea and wheeze occur frequently in young children. Most wheezing episodes in preschool children are associated with viral upper respiratory tract infections. The majority of children have become asymptomatic by the age of 6 years. About one in three preschool children with recurrent wheeze continue to wheeze after the age of six years, and these children are usually diagnosed with asthma.MedDRA version: 12.0Level: LLTClassification code 10003553Term: AsthmaEUCTR2009-009579-36-NL
终止
4 期
Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and WheezeWheezingDyspneaNCT00962299Princess Amalia Children's Clinic7