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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2023
• Main ID: NCT02888730
• Date of registration: 22/06/2016
• Prospective Registration: Yes
• Primary sponsor: Virginie ESCABASSE
• Public title: Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients AVASMUC
• Scientific title: Efficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled Trial
• Date of first enrolment: February 16, 2017
• Target sample size: 86
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02888730
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Virginie Escabasse, MD
• Affiliation: Creteil Hospital center (CHIC)

Key inclusion & exclusion 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)



Age minimum: 7 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rhinosinusitis

Cystic Fibrosis

Lung Diseases

Intervention(s)

Drug: Physiologic serum nebulized nasally

Drug: Tobramycin nebulized nasally

Primary Outcome(s)

Density of bacteria (in CFU/g log10) in sinus ostia of middle meatus samples at day 15 [Time Frame: 15 days]

Secondary Outcome(s)

Force Vital capacity (FCV) in both groups [Time Frame: day 0 and day 30]

rhinorrhea compared to baseline [Time Frame: day 0, 15, 30 and 90]

dysosmia compared to baseline [Time Frame: day 0, 15, 30 and 90]

facial pain compared to baseline [Time Frame: day 0, 15, 30 and 90]

density of bacteria (in CFU/g log10) in sinus ostia of middle meatus samples at day 30 and 90 [Time Frame: day 30 and day 90]

Hearing perception of the intensity (in db) and tone (Hz) of sound waves [Time Frame: day 0 and day 30]

nasal obstruction at day 90 compared to baseline [Time Frame: day 0, 15, 30 and 90]

Minimum inhibitor concentration of sputum bacteria to antibiotics [Time Frame: day 15, 30 and 90]

Score of the SM5 quality of life questionnaire in both groups [Time Frame: day 0, 15, 30 and 90]

Nasal endoscopic scores compared to baseline in both groups [Time Frame: day 0, 15, 30 and 90]

Forced Expiratory Volume in one second (FEV1) in both groups [Time Frame: day 0 and day 30]

Minimum inhibitor concentration of sputum bacteria to tobramycin [Time Frame: day 90]

mucopurulent secretions compared to baseline [Time Frame: day 0, 15, 30 and 90]

Score of the SNOT20 quality of life questionnaire in both groups [Time Frame: day 0, 15, 30 and 90]

Secondary ID(s)

AVASMUC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Henri Mondor University Hospital