Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial colonization is facilitated by a reduced mucociliary function and some previous studies suggest that the microbiology of the upper airways might influence the microbiology of the lower airway. The aim of this randomized control study is to demonstrate efficacy of antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores, quality of life and lung function

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginie ESCABASSE
• Collaborator: Henri Mondor University Hospital
• Treatments: Tobramycin

Criteria

Inclusion Criteria:

• Patients older than 7 years followed in the 6 CRCM centers (Créteil, Marseille, Nantes, Toulouse, Clermont-Ferrand and Nice). We choose to enroll children aged 7 years or more because as they have a better adherence to nebulization treatment than younger children.

• Diagnosis of cystic fibrosis confirmed by sweat test (>60mmol/L) and/or the identification of two CF-causing mutations

• Confirmed chronic rhinosinusitis by Ear Nose and Throat doctor by endoscopic examination: bilateral mucopurulent secretions at middle meatus present longer than 12 weeks with or without nasal polyps

• Positive bacteria susceptibility to tobramycin in samples from middle meatus

• Susceptibility of bacteria to tobramycin confirmed

• Pulmonary examination before enrollment

• Written informed consent obtained at enrollment for all patients (consent of minor's parent for children)

• Social security affiliation

Exclusion Criteria:

• - Oral antibiotic therapy one month before enrollment

• enrollment in another protocol with antibiotic

• Ongoing aerosolized tobramycin for endobronchial infection to avoid an overlap between treatment for lung and treatment for sinusitis

• Abnormal auditory acuity (decrease of 20dB in auditory acuity)

• Hypersensibility or allergenecity of aminoglycosides

• FEV < 25% or FVC of 40% or more of the value predicted for height

• Transplant patient or patient on transplant list

• Patient under nasal oxygen or under noninvasive ventilation

• Pregnant woman

• Breast-feeding

• No Social security affiliation

• Informed consent non obtained at enrollment for all patients (consent of minor's parent for children)