EUCTR2010-023090-19-IE进行中（未招募）不适用
A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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 participate in the study subjects must meet all of the following inclusion criteria:
- •1)Male or female with a confirmed diagnosis of cystic fibrosis defined by:
- •a.Clinical features consistent with the diagnosis of CF AND
- •b.Sweat chloride =60 mmol/L by pilocarpine iontophoresis; OR
- •c.Genotypic confirmation of CFTR mutation
- •2)Aged 18 years or older
- •3)Ability to provide samples for microbiological evaluation throughout the study. Note: sputum samples are preferred however cough swabs may be performed on occasions where sputum cannot be collected.
- •4)Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab documented within 24 months prior to Screening (Visit 1).
- •5)FEV1 must, at Screening (Visit 1), be between 35%-80% of the predicted normal value following adjustment for age, gender, and height according to the Knudson equation.
- •6)At Screening (Visit 1), no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF, which in the opinion of the investigator would preclude participation in the study
- •7)Female subjects of child bearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. Female subjects documented as being of non child-bearing potential are exempt from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as:
- •a.oral, injected or implanted hormonal methods of contraception; OR
- •b.placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
- •c.barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •8)Provision written informed consent
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •In order to participate in the study subjects must not meet any of the following exclusion criteria
- •1)Changes in underlying therapy (e.g., pulmonary massage therapy, bronchodilators, NSAIDs, antibiotic agents, pancreatic enzyme preparations, nutritional supplements and DNase within the 21 days prior to Day 1 (Visit 2). Subjects must be willing to remain on the same underlying stable therapy regimens for the duration of the study until the final follow-up visit at Day 111.
- •2)Changes in physiotherapy technique or schedule within 14 days prior to Day 1 (Visit 2).
- •3)Prohibited medications within 7 days prior to Day 1 (Visit 2).
- •4)Pulmonary exacerbation within 28 days of Screening (Visit 1)
- •5)Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening (Visit 1).
- •6)On-going acute illness. Subjects must not have needed an outpatient visit, hospitalization or required any change in therapy for other pulmonary disease between Screening (Visit 1) and Day 1 (Visit 2).
- •7)History of, or planned organ transplantation.
- •8)Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening (Visit 1), defined as having received treatment for ABPA.
- •9)Requirement for continuous (24 hour/day) oxygen supplementation.
- •10)Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 1 (Visit 2).
- •11)Initiation of cycled, inhaled tobramycin (TOBI) less than 4 months prior to Screening (Visit 1). Note: Chronic TOBI users are allowed to participate in this study, but subjects who have recently initiated chronic TOBI should have at least 2 cycles of TOBI in the preceding 4 months before being enrolled in this study. Chronic TOBI subjects should be starting an ‘off-TOBI’ period at Day 1 (Visit 2) so there will be no concomitant dosing of TOBI and assigned study medication.
- •12)Clinically significant abnormal findings on haematology or clinical chemistry. In addition any value = 3 x the upper limit of normal will exclude the subject from participating in the study.
- •13)Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.
- •14)Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in females of child-bearing potential at Screening (Visit 1).
- •15)Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 1 (Visit 2).
- •16)Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the Investigator.
- •17)Known allergies or intolerance to alginates (e.g., foods and food additives based on seaweed extracts).
- •18)Current malignant disease (with the exception of basal cell carcinoma; BCC).
- •19)Any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
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