EUCTR2016-004318-82-Outside-EU/EEA进行中（未招募）1 期
Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
ovartis Pharmaceuticals Corporation0 个研究点目标入组 200 人开始时间: 2017年5月15日最近更新:
适应症
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
- 200
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.Provide written informed consent, HIPPA (Health Insurance Portability and Accountability Act) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.
- •Confirmed diagnosis of CF
- •3.FEV1 at screening (Visit 1) =25% and = 80% of normal predicted values for age, sex, and height
- •4.P. aeruginosa must be present within 6 months prior to screening and at screening
- •5.Able to comply with all protocol requirements
- •6.Clinically stable in the opinion of the investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •History of Burkholderia cenocepacia (Bcc) complex within 2 years prior to screening and/or Bcc complex at screening
- •2.Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration
- •3.History of hearing loss or chronic tinnitus deemed clinically significant by the investigator
- •4.Serum creatinine 2 mg/dL or greater, BUN 40 mg/dL or greater, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
- •5.Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
- •6.Patients who are unable to discontinue previously received inhaled antibiotic regimen(s) (inhaled antibiotics are not allowed other than study drug)
- •7.Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2)
- •8.Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
- •9.Use of loop diuretics within 7 days prior to study drug administration
- •10.Administration of any investigational drug within 30 days prior to enrollment or 5 half-lives, whichever is longer
- •11.Signs and symptoms of acute pulmonary disease, e.g , pneumonia, pneumothorax
- •12.Hospitalization during the baseline visit
- •13.History of malignancy
- •14.Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
- •15.Patients with other clinically significant conditions (not associated with the study indication) which might interfere with the assessment of this study
- •16.Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
- •17.Pregnant or nursing (lactating) women
- •18.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.
研究者
相似试验
招募中
3 期
Addition of Tobramycin inhalation antibiotic treatment to standard IV antibiotic treatment for ventilator-associated pneumoniaNL-OMON40796Erasmus MC, Universitair Medisch Centrum Rotterdam42
进行中（未招募）
不适用
asale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilotsubjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airwaysEUCTR2008-000164-17-DEniversity of Jena14
已完成
3 期
ong-term inhaled nebulized tobramycin in patients with non-cystic fibrosis bronchiectasis. A randomized placebo controlled trial. The BATTLE study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.bronchiectasis10006436NL-OMON47248Medisch Centrum Alkmaar58
尚未招募
不适用
Inhalation of tobramycin for the patients with persistent respiratory infection by Psudomonas aeruginosaPersistent respiratory infection by Pseudomonas aeruginosaJPRN-UMIN000002893Kumamoto university hospital5
进行中（未招募）
不适用
Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosisAdult patient with cystic fibrosisMedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-001821-26-ITFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO