A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

· Confirmed diagnosis of cystic fibrosis by documented sweat chloride 60 mEq/L or greater by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for DF508 genetic mutation (or heterozygosity for two well-characterized mutations) and two clinical findings consistent with CF.
· Male and female subjects greater than or equal to 6 years of age at the time of screening.
· FEV1 at screening must be greater than or equal to 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.
· P aeruginosa must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
· Able to comply with all protocol requirements.
· Clinically stable in the opinion of the investigator.
· Use of an effective means of contraception in females of childbearing potential.
· Provide written informed consent and assent (as appropriate) prior to the performance of any study-related procedure
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
· Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration.
· Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
· Serum creatinine 2 mg/dl or more, BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria.
· Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.
· History of hearing loss or chronic tinnitus deemed clinically significant by the investigator.
· Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.
· Use of loop diuretics within 7 days prior to study drug administration.
· Use of any investigational treatment within 28 days prior to study drug administration.
· Initiation of treatment with chronic macrolide therapy within 28 days prior to study drug administration (subjects may be taking chronic macrolide therapy at the time of enrollment into TIP003, but they must have initiated treatment more than 28 days prior to study drug administration).
· Initiation of treatment with dornase alpha within 28 days prior to study drug administration (subjects may be taking dornase alpha at the time of enrollment into TIP003, but they must have initiated treatment more than 28 days prior to study drug administration).
· Initiation of treatment with inhaled steroids (or increased dose) within 28 days prior to study drug administration (subjects may be taking inhaled steroids at the time of enrollment into TIP003, but they must have initiated treatment more than 28 days prior to study drug administration).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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