EUCTR2014-001029-34-GR进行中（未招募）1 期
Evaluation of the effect of the inhaled combination budesonide -formoterol (Pulmoton® Elpenhaler®) in exhaled nitric oxide (FeNO) of patients with bronchial asthma. - Effect of Pulmoton Elpenhaler in FeNO of patients with bronchial asthma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria.
- •1) Eligible ages for the study: 18-65 years
- •2) Eligible for studying gender: Men and Women
- •3) Non smokers
- •4) History compatible with asthma and clinical diagnosis of asthma
- •5) Improvement in FEV1> 12% and> 200ml in spirometry in bronchodilation test
- •6) FeNO> 30ppb
- •7) Patients who have fully understand the study protocol and signed the consent form
- •8) Patients with asthma, who are not treated with ICS or montelukast for the last three months prior to entering the study
- •9) Patients who are not treated corticosteroids for the last three months prior to entering the study
- •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 108
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 ) Patients with hypersensitivity to budesonide, formoterol or lactose
- •2 ) Patients , regardless of gender , age <18 years
- •3 ) Patients with asthma,treated with montelukast or ICS for the last three months prior entering the study
- •4 ) Patients being treated with corticosteroids fot the last three months prior entering the study
- •5) Patients treated with potent CYP3A4 inhibitor
- •6 ) Patients with severe cardiovascular disease or prolongation of QTc
- •7) Patients with untreated hypokalaemia
- •8) Patients with severe liver cirrhosis
- •9) Patients with thyrotoxicosis , pheochromocytoma or diabetes
- •10) Patients with other lung disease ( COPD, bronchiectasis , allergic rhinitis without treatment , etc . )
- •11) Patients during asthma exacerbation
- •12) Female patients who are pregnant , breastfeeding or planning to become pregnant
- •13) Patients with known existing tumor or autoimmune disease known
- •14) Patients with known psychiatric illness, or other condition which interferes with patient compliance to the procedures of the study
- •15) Patients with respiratory infection the last 8 weeks
- •16) Patients with severe asthma
研究者
相似试验
进行中（未招募）
2 期
An investigation into how adding an inhaled steroid to COPD treatment may potentially protect against heart disease.Chronic Obstructive Airways Disease [COPD]RespiratoryISRCTN29148209Hull University Teaching Hospitals NHS Trust40
招募中
不适用
The concurrent effects of inhalation aromatherapy with Damask Rose and Lavender essential oils on the amount of anesthetic drugs consumption in patients undergoing donor place dressing changeBurn.Burn of second degree, body region unspecifiedIRCT20171123037599N2Mashhad University of Medical Sciences60
已完成
3 期
Evaluation of the effect of nano-based inhalation solution to relieve shortness of breath in COVID-19 patientsIRCT20190226042851N1Ahvaz University of Medical Sciences40
已完成
不适用
What is the effect of inhalational anaesthetic agents on blood glucose levels in non diabetic patients?CTRI/2021/12/038579All India Institute of Medical Sciences Raipur105
尚未招募
不适用
aromatherapy with spirit and ginger oil for control of nausea and vomiting in postoperative patientsCTRI/2020/03/023759DR GAURAV AGARWA