EUCTR2012-002106-48-IE进行中（未招募）1 期
An Investigative Study to characterize gene expression patterns in myeloid cells that are triggered during acute asthma exacerbations, and to identify associated genes/gene networks that are Omalizumab sensitive.
niversity College Dublin0 个研究点目标入组 20 人开始时间: 2012年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •In order to be eligible, subjects must:
- •1.Have a current diagnosis of asthma
- •2.Have preexisting or currently documented atopy
- •3.Fulfil the definition in section 3.2 for acute exacerbation at the time of enrolment
- •4.Have a FEV1 of less than 80% of predicted
- •5.Be aged between 18 and 75yrs. old, inclusive
- •6.Have a normal chest X-ray and EKG
- •7.Have a normal DLCO (diffusion in the lung of carbon monoxide)
- •8.Have a negative urine pregnancy test (women of childbearing potential) at the Screening visit. Women who are surgically sterile or those who are post-menopausal for at least two years are not considered to be of childbearing potential.
- •9.Women of childbearing potential must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit. A reliable double barrier method of contraception is considered to be a combination of TWO of the following: birth control pills/ implants/ injections. Intrauterine devices, spermicide, diaphragms or condoms.
- •10.Subjects must be able to provide written informed consent and must sign an REC approved informed consent form prior to initiation of any study procedures.
- •11.40 subjects must have confirmed allergy and randomization will assign equal numbers of these to treatment/placebo arms (see 6.3 below).
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who meet any of the following criteria are ineligible for participation in the study:
- •1.If onset of acute exacerbation has been > 48 hours
- •2.If they have a total lung capacity (TLC) less than 80 % of predicted normal or a forced expiratory volume in one second (FEV1) > 80% of predicted normal at baseline
- •3.If there is evidence of pneumonia, COPD or congestive heart failure
- •4.Greater than 5 pack year history of smoking.
- •5.Have ever had omalizumab in the past.
- •6.Female subjects who are pregnant or breastfeeding
- •7.Presence of a serum ALT or AST greater than 2 times the upper limit of normal at any time during the Screening period
- •8.Have a contraindication to treatment with omalizumab.
- •9.Have a history of malignancy
- •10.Have demonstrated noncompliance with previous regimens
- •11.Have a recent history of abusing alcohol, or illicit drugs.
- •12.Have participated in a clinical study involving an investigational drug or device within four weeks before the Screening visit.
研究者
相似试验
尚未招募
不适用
The complete placental transcriptome in health and disease in pregnant Caucasian womeGene expression in placentas collected from fetuses from pregnancies complicated by preeclampsia or intrauterine growth restriction compared to those from healthy pregnancies.Reproductive Health and Childbirth - Fetal medicine and complications of pregnancyACTRN12612001179820The University of Adelaide600
尚未招募
2 期
Treatment of Rheumatoid Arthritis with Unani Medicine and its relation with genesCTRI/2023/05/053034Central Council for Research in Unani Medicine
尚未招募
不适用
Analysis of Gene expression to elucidate the cause of endometriosis and endometriosis associated ovarian cancer.Endometriosis assciated ovarian cancerJPRN-UMIN000024848Osaka Medical College100
招募中
不适用
Analysis o expression level of genes and proteins in the corneaAnalysis o expression level of genes and proteins in the corneaJPRN-UMIN000043249Doshisha University18
已完成
不适用
Analysis of differential gene and protein expression for the in vitro detection of drug allergyDrug allergyZ88Personal history of allergy to drugs, medicaments and biological substancesDRKS00026656Bundesinstitut für Arzneimittel und MedizinprodukteAbteilung Forschung57