TAPAS study in patients with CF
Recruiting
- Conditions
- Cystic FibrosisTobramycin
- Registration Number
- NL-OMON27235
- Lead Sponsor
- Erasmus Medical Center - Sophia Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
• Age ≥ 12 years
• Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
Exclusion Criteria
• Severe acute exacerbation of pulmonary infection (needing intravenous treatment) within one month prior to start or during the study;
• Known impaired kidney function (estimated creatinine clearance < 60 ml/min);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in FEF75 (Z-score and L/s) after 4 weeks of targeted treatment
- Secondary Outcome Measures
Name Time Method • Change in FEV1, FVC, FEF25, FEF50, MMEF25-75 (Z-scores and absolute values);<br /><br>• Change in Lung Clearance Index (LCI) measurements as assessed by multiple breath washout;<br /><br>• Change in Pa bacterial CFUs (defined as the log10 value for the number of Pa CFUs per millilitre of sputum, either expectorated or collected by suction of the oropharynx);<br>• Change in percentage of trapped air on MRI (% of total lung volume);<br /><br>• Change in FEV1 before and after nebulisation (safety parameter);<br /><br>• Systemic bioavailability of inhaled tobramycin, defined by trough level;<br /><br>• Change in creatinine and blood urea nitrogen (BUN) values as measure of early renal toxicity;<br>• Change in hearing function (measured by HFPTA);<br>• Compliance rate;<br /><br>• Patient satisfaction (use of device);<br /><br>• Cystic Fibrosis questionnaire-revised (CFQ-R): respiratory symptoms scale scores and treatment burden scale scores.