A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis

CompletadoFase 4ClinicalTrials.gov

ID: NCT01519661Tipo: INTERVENTIONALInicio: 1 de ene de 2012Fin estimado: 1 de ene de 2014

Traducción no disponible, mostrando original

Resumen

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

Elegibilidad

Edad mínima: 6 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of Cystic Fibrosis
FEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation
Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening

Criterios de exclusión

History of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening
Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
History of hearing loss or chronic tinnitus deemed clinically significant
Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic
Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
Use of loop diuretics within 7 days prior to study drug administration

Intervenciones

drug

TBM100

Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Paraná, Entre Ríos Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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