A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003

Conditions: Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762

Registration Number: EUCTR2005-003772-37-HU

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

· Confirmed diagnosis of CF by the presence of one or more clinical features of CF in
addition to:
- a quantitative pilocarpine iontophoresis sweat chloride test of > 60 mEq/L; or
- identification of well-characterized disease-causing mutations in each CFTR
gene; or
- an abnormal nasal transepithelial potential difference characteristic of 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. The definition of effective contraception will be based on the judgment of the investigator or a designated associate. Acceptable methods of contraception include oral, depot and injectable contraceptives, total abstinence and surgical sterilization (e.g., bilateral tubal ligation). Double barrier methods (i.e. combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) are acceptable with the exception of a combination of condom and diaphragm. Emergency contraceptive treatment after intercourse, coitus interruptus, single barrier methods and periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) are not considered effective forms of contraception.
· 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) no
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 CTBM100C2302, 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 CTBM100C2302, 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 CTBM100C2302, but they must have initiated treatment more than 28 days prior to study drug administration).
· Initiation of treatment with inhaled hypertonic saline (HS) within 28 days prior to
study drug administration (subjects may be taking inhaled HS at the time of
enrollment into CTBM100C2302, but they must have initiated treatment more than
28 days prior to study drug administration and be on a stable regimen). In addition,
patients should be instructed to take their HS at least 30 minutes before their PFT.
Patients should be consistent with the timing of taking their HS at home, or clinic
prior to their PFT.

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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