EUCTR2008-002391-97-BE进行中（未招募）不适用
Open-label, prospective study to assess the effects of formoterol and beclometasone dipropionate combination therapy on central and peripheral airway dimensions in asthmatic patients
niversity Hospital Antwerp; Department Respiratory Medicine0 个研究点开始时间: 2008年6月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Patients with asthma as defined by the current GINA guidelines12 (for details of diagnosis of asthma please refer to the addendum in section 15)
- •Patients can belong to 3 categories:
- •?Group 1 (n=8): Steroid naïve patients, not using IHC during the last 2 months and not controlled with symptomatic use of SABA
- •?Group 2 (n=14): Patients not well controlled (partially controlled or uncontrolled according to the GINA guidelines) when using medium daily dose of inhaled corticosteroids and long acting inhaled ß2 agonists (for definition please refer to the addendum in section 15) given for at least 6 weeks in a powder inhaler
- •?Group 3 (n=14): Patients well controlled (according to GINA guidelines) when using medium daily dose of inhaled corticosteroids and long acting inhaled ß2 agonists (for definition please refer to the addendum in section 15) given for at least 6 weeks in a powder inhaler
- •From group 1, 2 patients and from group 2 and 3 , 3 patients will at random be assigned to subgroup 2.
- •2.Male or female patients aged =18 years
- •3.Patients with a documented positive response to the reversibility test (i.e. FEV1 increase = 12% and 200mL from baseline value after 4 puffs of 100 µg of inhaled salbutamol pMDI) within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting ß2 agonists or a documented positive response to the methacholine challenge test
- •4.Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
- •5.Written informed consent obtained
- •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
- •1.Pregnant or lactating females or females at risk of pregnancy
- •2.Inability to carry out pulmonary function testing
- •3.Diagnosis of COPD as defined by the current GOLD guidelines13
- •4.History of near fatal asthma
- •5.Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
- •6.Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day
- •7.Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
- •8.Patients with a QTc interval (Bazett’s formula) at the screening visit ECG test >450 msec
- •9.Cancer or any other chronic disease with poor prognosis and /or affecting patient status
- •10.History of alcohol or drug abuse
- •11.Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
- •12.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- •13.Patients who received any investigational new drug within the last 8 weeks prior to the screening visit
- •14.Patients treated with any non-permitted concomitant medication (see section 7.2.)
研究者
相似试验
已完成
不适用
A study of effects of Calcium and Vitamin D supplementation on depletion of jaw bones in patients having all missing teeth.â??CTRI/2017/09/009626Indian Council of Medical Research150
进行中（未招募）
1 期
AEUCTR2020-002356-20-HUChiesi Farmaceutici S.p.A.30
招募中
1 期
Open-label, prospective study evaluating the efficacy and safety of Tirbanibulin 1% (Klisyri®) in the treatment of superficial basal cell carcinomaCTIS2023-505971-66-00Centre Hospitalier Universitaire De Nice55
招募中
不适用
A study for evaluation of utility of indomethacin in tuberculous meningitis patientsCTRI/2018/02/011722Dr Ravi Uniyal
已完成
4 期
An open label, pilot study to determine the effect of weekly injections of Invicorp on male Erectile Dysfunction (ED) following surgery to remove the prostateErectile Dysfunction (ED) post radical prostatectomyUrological and Genital DiseasesISRCTN77251669RestoriT Ltd24