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Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND

Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003628-39-IT
Enrollment
Unknown
Registered
2008-04-08
Start date
2007-11-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinosinusal infection by Pseudomonas a. e/o Staphylococcus a. in patients with Cystic Fibrosis MedDRA version: 9.1 Level: HLGT Classification code 10024970 Term: Respiratory tract infections

Interventions

Product Code: TNSE Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6- Pharmaceutical form

Sponsors

ECUPHARMA S.R.L.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Documented Cystic Fibrosis diagnosis based on the following: positive sweat test (chloride concentration = 60mEq/l or higher; two CF genotype mutations. -Documented nasal infection by Pseudomonas a. and/or Staphylococcus a. -Forced Expiratory Volume in one second (FEV1) that was at least 50% of the predicted value. - Age (6 to 22 years) -Compliant patients -Informed consent written provided by the patient and/or parent or legal tutor according to the current law. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Hypersensitivity to aminoglycosides -Burkholderia cepacia cronic infection -Pregnancy and lactation -Septal deviation -Current and recurrent epistaxis -Rhinosinusal polypose -Endoscopic nasal surgery during the previous 6 months -Systemic antibiotic administration during the 30 days before the study or during it -Documented periodic or aperiodic allergic rhinitis

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the local tollerability of the tobramycin 3% nasal spray formulation;Secondary Objective: To evaluate the efficacy of the tobramycin 3% nasal spray formulation to reduce the bacterial density of the nasal swab. To evaluate the improvement of any symptoms related to the rhinosinusal infection.;Primary end point(s): Nasal local tollerability assessed by rhinofibroscopic examination at V0 and V2.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 21, 2026