Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of an Inhaled Dry Powder Formulation of CaEDTA when given with Inhaled TOBI Dry Powder for treatment of Pseudomonas aeruginosa infection in Cystic Fibrosis Patients - a Phase I dose-ranging Study

Telethon Kids Institute0 个研究点目标入组 24 人开始时间: 2018年10月17日最近更新: 2019年10月7日

适应症

试验速览

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•Male or female patients 12 or more years of age with a documented diagnosis of CF (positive sweat chloride test, genotype with two identifiable CF mutations) accompanied by one or more clinical features consistent with the CF phenotype
•- FEV1 >40% of predicted values
•- At least one positive sputum culture for PsA in the previous 12 months
•- Due to start a four week course of inhaled tobramycin dry powder for treatment of
•PsA infection
•- Must be able to give informed consent or have legally acceptable representative who can give informed consent in accordance with ICH/GCP
•- Females of child-bearing potential must agree to use an acceptable method of contraception for the duration of the trial and to have 4 pregnancy tests. Appropriate forms of contraception include; willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and 3-week follow-up period.
•- Patient capable of using a dry powder inhaler

•- Patients who in addition to culturing PsA in their sputum, have also cultured B Cepacia, Staph aureus, Achromobacter, Stenotrophomonas, Acinetobacter, and non-tuberculous mycobacterium species within the last year.
•- Known hypersensitivity to the investigational product or its components or known relevant medication allergy
•- Currently taking oral prednisone or IV methylprednisolone for ABPA
•- Participation in another study with an investigational drug within 1 month of the planned first dose of investigational product
•- Known relevant substance abuse
•- Female patients who are pregnant or lactating
•- Clinically significant disease or other medical condition other than CF or CF-related conditions that would, in the opinion of the Investigator, compromise the safety of the patient or quality of the data

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