Safety and tolerability of an inhaled chelator in combination with antibiotic treatment for lung infection in patients with cystic fibrosis
- Conditions
- cystic fibrosisRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12618001715268
- Lead Sponsor
- Telethon Kids Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method