Targeting Antibiotics to Pseudomonas aeruginosa in Small airways study in patients with Cystic Fibrosis

Phase 1

• Conditions: Cystic Fibrosis and chronic infection with Pseudomonas aeuroginosa; MedDRA version: 22.1Level: LLTClassification code 10057582Term: Lung infection pseudomonalSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001401-41-IT
• Lead Sponsor: ERASMUS UNIVERSITY MEDICAL CENTER ROTTERDAM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

•Age = 12 years
•Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
•Chronic Pa colonization requiring maintenance therapy with inhaled tobramycin, defined according to the Leeds criteria (>50% Pa positive airway cultures over last 12 months) 22;
•Small airways obstruction present on spirometry (defined as follows: dissociation between FVC and FEF75 values (i.e. FEF75 at least 20% (absolute percent predicted) less than FVC);
•Ability to breathe through a mouthpiece and to use the inhaler;
•Ability to perform lung function tests;
•Written informed consent (12-18 years: child and parents; = 18 years: patient).

Are the trial subjects under 18? yes
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 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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);
•Known aminoglycoside hypersensitivity;
•Start of nephrotoxic or ototoxic drugs, e.g. aminoglycosides, within 1 month prior to start or during the study;
•Use of Tobramycin Inhalation Powder as part of the maintenance therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified