EUCTR2016-000978-38-IT进行中（未招募）1 期
Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Respiratory Tract Infections in adults with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months. - ACASP
DAIICHI SANKYO ITALIA S.P.A.0 个研究点目标入组 210 人开始时间: 2019年9月2日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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.
- •2.Aged 18 to 80 years achieved.
- •3.Patients with at least 6 RTI/LRTI or URTI episodes confirmed by medical recording or reported history, with a maximum of 18, during the 12 months prior randomization.
- •4.Patients who given their written consent for participation in the study.
- •5.Possibility to have regular telephone contacts with patient.
- •6.Patients who are supposed will be cooperative with regard to compliance with study-related constraints.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Women with childbearing potential not using effective contraception (oral contraceptives, intrauterine device, tubal ligation or other efficient procedures).
- •2.Women referring, at the screening visit, to be pregnant or breast feeding or women likely to become pregnant during the time of the study.
- •3.Previous major surgery in the oral, nasal or respiratory tracts (except tonsillectomy or adenectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tracts due to intubation
- •4.Anatomic abnormalities of oral, nasal or respiratory tracts.
- •5.Fever at the time of randomization.
- •6.Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy.
- •7.Acute broncho-pulmonary infection (bronchiolitis, pneumonia, tuberculosis) at the time of randomization.
- •8.Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral or inhalers) or bronchiectasis regularly treated with corticosteroids.
- •9.Oral, nasal or respiratory abscess, including also chronic suppurative otitis media.
- •10.Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
- •11.Known a-1 anti-trypsin deficiency from patient’s medical history/records.
- •12.Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis).
- •13.Acute intestinal infections.
- •14.Severe systemic diseases, including Human Immunodeficiency Virus (HIV) infection, severe haematological diseases, cancer and otherwise severely compromised patients.
- •15.Medical history of hypersensitivity to Paspat 3 mg tablets or any drug excipients.
- •16.Any on-going specific or non-specific immunotherapy with pharmacological effects on the immune system (including homeopathic or phytotherapy) whatever route of administration, 3 months prior to inclusion and/or planned during the course of the study, except regular vaccinations.
- •17.Any homeopathic or phytotherapy treatment used for preventing recurrent infections or for improving immunity in the 6 months prior randomization.
- •18.Participation in another clinical trial at the time of the randomization or within 4 weeks before randomization.
- •19.Patient’s or family’s difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.
研究者
相似试验
进行中（未招募）
1 期
Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Upper Respiratory Tract Infections in children with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months.upper respiratory tract infections in children at high risk of reccurence.EUCTR2016-000979-24-ITDaiichi Sankyo Italia SpA210
进行中（未招募）
不适用
A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravisMedDRA version: 7.1Level: LLTClassification code 10028417Myasthenia gravisEUCTR2004-000596-34-CZF.Hoffmann-La Roche Ltd.136
进行中（未招募）
1 期
A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)EUCTR2005-001688-74-GBGuy's & St Thomas' NHS Foundation Trust70
尚未招募
3 期
In this study Garcinol 20% would be compared with an inert substance in reducing the risk of metabolic syndrome in obese individuals.CTRI/2020/02/023571Sami Labs Limited
进行中（未招募）
1 期
A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2Autosomal Dominant Polycystic Kidney DiseaseEUCTR2011-000138-12-ITIST. DI RICERCHE FARMACOLOG. M. NEGRI100