EUCTR2014-000844-13-SE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). See Section 12.10 for a GLI calculator. 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 for lactose intolerance unknowns at screening. Subjects that have previously received inhaled formulations containing lactose without any allergic or tolerance issues are allowed to proceed without a skin test. For subjects demonstrating a positive skin prick test for milk allergy but have no problems with eating milk and lactose products, the decision will be up to the investigator’s discretion.
- •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).
研究者
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