EUCTR2022-000476-18-SK招募中1 期
Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) - COPILOT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects, ages 12 years and older:
- •a. Step A: ages 18 years and older
- •b. Step B: ages 12 years and older
- •2. Previous diagnosis of cystic fibrosis as confirmed by:
- •a. documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test prior to initiation of therapy with CFTR modulators (e.g., elexacaftor, tezacaftor, ivacaftor), if applicable; or
- •b. two well-characterized genetic mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene; and
- •c. symptoms characteristic of cystic fibrosis
- •3. Persistent airways infection with P. aeruginosa as evidenced by:
- •a. positive P. aeruginosa in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening; or
- •b. history of inhaled antibiotic treatment for suppression of P. aeruginosa
- •4. Stable treatment regimen of CF therapeutics for at least 2 months prior to randomization
- •defined as:
- •a. regimen of inhaled antibacterials for either at least 2 months of continuous therapy or at least a total of 56 days of consecutive on treatment periods in case of cyclical therapy (e.g. 28 day on treatment, followed by 28 days off treatment, followed by another 28 days on treatment) prior to randomization AND
- •b. no changes in either any current treatment regimen or initiation of treatment with hypertonic saline, dornase alfa, CFTR modulators or other CF specific therapeutics.
- •5. FEV1 at screening of =30% of predicted values
- •6. Arterial oxygen saturation (SpO2) = 90% on room air at screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Current need for daily continuous O2 or requirement for > 2 liters/min at night
- •2. History of any investigational drug/device use within 28 days of screening or within 6 half-lives of investigational drug (whichever is longer)
- •3. History of lung or liver transplantation
- •4. History or current diagnosis of myasthenia gravis or porphyria
- •5. Abnormal renal or hepatic function measured in serum chemistry at screening (AST or ALT > 3x upper limit of normal (ULN); Creatinine > 2x ULN)
- •6. Positive pregnancy test at screening
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