EUCTR2018-000378-30-PL进行中（未招募）1 期
A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Confirmed diagnosis of Cystic Fibrosis (CF) defined as a sweat chloride value =60 mmol/L by quantitative pilocarpine iontophoresis or genotypic confirmation of CFTR mutation.
- •Age 12 years or older.
- •Male or female patients with any ethnicity.
- •FEV1 at screening in the range of =40% and = 90% of the predicted normal for age, sex, and height, according to the GLI equation (Eur Respir J. Dec 2012; 40(6): 1324–1343).
- •History of Pseudomonas aeruginosa (PA) infection with at least one positive microbiological PA testing during the last 12 months before the Screening Visit.
- •History of antibiotic treatment due to PA infection (not for eradication therapy) during the last 12 months
- •Concomitant treatment with inhaled tobramycin, colistin, aztreonam or levofloxacin (either cycled or continuous) for at least 3 months at screening to treat PA infection. In case of cycled antibiotic treatment, the treatment should start with an active cycle at the day of randomisation (+/- 2 day) (together with the IMP intake).
- •Stable CF disease as judged by the investigator.
- •Willing to remain on a stable CF medication regimen (standard of care; SOC) during the study.
- •Women of child-bearing potential must have a negative urine pregnancy test at the Screening and Randomisation Visit.
- •Male and female patients must use acceptable contraceptive methods for the duration of the study. Male and female patients without child-bearing potential (i.e. who are infertile, surgically sterile or post-menopausal) are exempted from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as one or a combination of the following:
- •o oral, injected, transdermal or implanted hormonal methods of contraception;
- •o placement of an intrauterine device (IUD) or intrauterine system (IUS);
- •o barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- •Capable of inhaling dry powder.
- •Willing to sign informed consent (in adolescent patients: parent(s) or legal guardian(s) must be willing to sign the consent form according to the national regulatory requirements and the adolescent patients must be willing to sign the assent form.
- •Willing and able to follow the study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Use of hypertonic saline more than 2 times a day. If hypertonic saline is used, IMP inhalation should be taken 15 minutes after completion of hypertonic saline therapy.
- •Use of CFTR modulator therapies.
- •Clinically significant abnormal findings or any value > 3x the upper normal limit of haematology or clinical chemistry parameters, except for the inflammation marker C-reactive protein (CRP), as CRP is standardly increased in CF patients. Further exceptions may be allowed in the case of elevated gamma-GT (GGT) values, exceeding this threshold. These GGT cases will be carefully scrutinised alongside other clinical and laboratory data. Following discussion between the medical monitor and the DSMB clinical experts to exclude significant liver injury, the subject may be enrolled in the study.
- •History of any comorbidity that, in the opinion of the investigator, might distort the results of the study or cause an additional risk in administering study drug to the patient.
- •Pulmonary exacerbation within 28 days prior to randomisation.
- •Change in CF therapy within 28 days before randomisation (first dose of IMP).
- •Pregnant or breastfeeding females.
- •History of allergic reactions of CTCAE grade 3 or 4 to the ingredients of the IMP incl. lactose and milk protein.
- •Patients unable to perform pulmonary function tests according to the ATS/ERS criteria.
- •Uncontrolled or unstable acute or chronic diseases (e.g. congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations) that would limit the compliance with study requirements in the opinion of the investigator.
- •History of, or planned organ transplantation.
- •Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to the Screening Visit, defined as having received pharmacological treatment for ABPA.
- •Requirement for continuous (24 hour/day) oxygen supplementation.
- •Patients currently receiving any other investigational treatment, or who have participated in a clinical study within 4 weeks (28 days) prior to the screening visit.
- •Current malignant disease (with the exception of basal cell carcinoma and cervical neoplasia).
- •Any medical condition, other than CF, which in the opinion of the investigator exposes the patient to an unacceptably high risk.
- •Patients with documented or suspected, clinically significant, alcohol or drug abuse as per Investigator’s discretion.
研究者
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