EUCTR2014-000844-13-DK进行中（未招募）1 期
A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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 with a confirmed diagnosis of cystic fibrosis defined by:
- •a.Clinical features consistent with the diagnosis of CF [(Rosenstein BJ and Cutting GR 1998)]; AND Sweat chloride =60 mmol/L by pilocarpine iontophoresis;
- •b.Genotypic confirmation of CFTR mutation
- •2)Aged 18 years or older
- •3)Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab documented within 24 months prior to Screening (Visit 1).
- •4)FEV1 must, at Screening (Visit 1), be between 40%-100% of the predicted normal value following adjustment for age, gender, and height according to the Global Lung Initiative (GLI) equation (Eur Respir J. Dec 2012; 40(6): 1324–1343)). For subjects to be included in the LCI assessment at selected sites, the FEV1 at screening should be in the range of 60-100%.
- •5)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
- •6)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 (Section 4.2.9) are exempt from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as:
- •a.oral, injected transdermal 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
- •7)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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1)Changes in underlying therapy (e.g., chest physiotherapy, bronchodilators, NSAIDs, antibiotic agents, pancreatic enzyme preparations, nutritional supplements and DNase within the 14 days prior to Day 0 (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 98.
- •2)Changes in physiotherapy technique or schedule within 14 days prior to Day 0 (Visit 2).
- •3)Prohibited medications within 7 days prior to Day 0 (Visit 2). Prohibited medications are described in Section 5.6.
- •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)Lactose intolerance/milk allergy. A skin test for milk allergy will be performed at screening.
- •7)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 0 (Visit 2).
- •8)History of, or planned organ transplantation.
- •9)Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening (Visit 1), defined as having received treatment for ABPA.
- •10)Requirement for continuous (24 hour/day) oxygen supplementation.
- •11)Diagnosed with the G551D-mutation, and currently on concomitant treatment with Ivacaftor (Kalydeco).
- •12)Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 0 (Visit 2). Subjects on hypertonic saline can if needed switch to isotonic saline 7 days prior to Day 0.
- •13)Initiation of cycled, inhaled tobramycin (TOBI) and Colistin less than 4 months prior to Screening (Visit 1). Note: Chronic TOBI and Colistin users are allowed to participate in this study, but subjects who have recently initiated chronic TOBI or Colistin should have at least 2 cycles of TOBI or Colistin respectively in the preceding 4 months before being enrolled in this study. Chronic TOBI and Colistin subjects should be starting an ‘off-TOBI’ or alternatively ‘off-Colistin’ period at Day 0 (Visit 2), to make sure that the treatment is phased in line with the antibiotic treatment.
- •14)Concomitant use of all other marketed antibiotic agents is permitted, providing subjects are willing to remain on the same regimens within the 21 days immediately prior to Day 0 (Visit 2) and for the entire duration of the study (until Day 98).
- •15)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.
- •16)Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.
- •17)Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in females of child-bearing potential (Section 4.2.9) at Screening (Visit 1).
- •18)Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 0 (Visit 2).
- •19)Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the Investigator.
- •20)Current malignant disease (with the exception of basal cell carcinoma and cervical neoplasia).
- •21)Any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere
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