EUCTR2005-000374-48-DK进行中（未招募）不适用
A randomized, open label comparative study to determine the proportion of asthma patients on Seretide Diskus 50/250 mcg b.i.d. achieving total control when given medication and compli-ance enhancement training compared to those receiving medica-tion only.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Male or female subjects 18 years of age or above
- •2) Diagnosed with persistent asthma
- •3) Treated as an outpatient
- •4) Treated with up to or equal to 250 mcg fluticasone or up to or equal to 320 mcg budesonide (ex actuator, corresponding to 400 mcg budesonide labelled) b.i.d pre-study (or equivalent for other inhaled corticosteroids) or treated with less than or equal to 50 mcg salmeterol b.i.d pre-study or less than or equal to 9 mcg formoterol (ex actuator, corresponding to 12 mcg labelled formoterol) b.i.d pre-study and/or treated with short acting bronchodilator
- •5) Non- or ex-smoker (ex-smoker defined as not having smoked during the last year)6) Subjects must give full written, dated, and signed informed consent
- •7) Female subjects must be post-menopausal, surgically sterile, or using effective contraception (Pearl index > 99).
- •8) Subject able to comply with the use of the AM2 and the AQLQ in the local language
- •Inclusion criterion for entry into treatment period 2
- •9) During treatment period 1, subjects must have failed to achieve the criteria for Total control
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria valid for the entire study period
- •1) Known or suspected Chronic Obstructive Pulmonary Disease (COPD)
- •2) Pregnant or lactating
- •3) Participating investigator, employee of an investigator, or family member of any of the aforementioned
- •4) Smoking history: Pack-years: 10 years or above
- •5) Have known clinical or laboratory evidence of a serious uncontrolled systemic disease
- •6) Known hypersensitivity to any substance contained in investigational product or p.r.n medication
- •7) Participation in a clinical trial with study drug
- •Exclusion criteria for specifically entry into run-in period
- •8) Treatment with oral corticosteroid within 2 months prior to screening visit
- •9) Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit
- •10) Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit
- •11) Participation in a clinical trial with study drug within 1 month prior to screening visit
- •Exclusion criteria specifically for entry into treatment period 1
- •12) Changes in asthma medication during the run-in period
- •13) Treatment with systemic corticosteroids during the run-in period
- •14) Respiratory tract infection (microbiologically verified) during the run-in period
- •15) More than one week of Total control prior to baseline visit
- •Exclusion criteria specifically for entry into treatment period 2
- •16) Changes in asthma medication during the treatment period 1 as listed in protocol section 8.2.
- •17) Respiratory infection (microbiologically verified) during treatment period 1
- •18) Total control achieved during treatment period 1
研究者
相似试验
已完成
3 期
A comparative study on efficacy , safety and reduction of diabetic complications, with regimens of metformin, glimeperide, &vildagliptin vs metformin, Glimeperide, & dapagliflozin in type â?? 2 diabetic patients.CTRI/2017/04/008424Siddhartha Medical College435
已完成
3 期
A comparative clinical study to evaluate efficacy and safety of fixed dose combination of Ceftriaxone + Sulbactam (CSE 1034) vs Ceftriaxone in patients suffering from various bacterial infectionsCTRI/2010/091/000174Venus Remedies Limited654
已完成
2 期
Comparative study to evaluate the Effectiveness of GanjhuVirTM a herbal antiviral in Cases of Dengue Fever with ThrombocytopeniaCTRI/2019/01/017096Radhika Ayurveda Research and Development
已完成
3 期
A clinical trial which is for various bacterial infectionsCTRI/2010/091/001046Venus Remedies Limited200
招募中
4 期
Comparison of serum levels of cobalamine after giving a thrice weekly dose versus once weekly dose of methylcobalamin in patients suffering from peripheral neuropathyCTRI/2017/02/007804Wockhardt limited34