A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).
- Conditions
- Pseudomonas aeruginosa infection in cystic fibrosis patientsMedDRA version: 9.1Level: LLTClassification code 10021860Term: Infection pseudomonas aeruginosa
- Registration Number
- EUCTR2008-002318-22-LV
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Main inclusion criteria (refer to full protocol for comprehensive list)
• 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 aged 6 years to 21 years of age at the time of screening.
• FEV1 at screening must be >= 25% and <= 80% 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 expectorate a sputum sample at screening.
• Use of an effective means of contraception in females of childbearing potential.
• Clinically stable in the opinion of the investigator to be treated according to this protocol.
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
Main exclusion criteria (refer to full protocol for comprehensive list)
• FEV1 at baseline (visit 2) is < 25% or > 80% of normal predicted values for age, sex, and height based on Knudson criteria, and/or FEV1 at baseline (visit
2) deviates by >= 10% from the FEV1 measured at screening (visit 1).
• Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening.
• Any use of systemic anti-pseudomonal antibiotics within
28 days prior to study drug administration.
• Serum creatinine 2 mg/dl or above, BUN 40 mg/dl or above, or an abnormal urinalysis defined as 2+ or greater proteinuria.
• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
• Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax.
• Administration of any investigational drug within 30 days prior to enrollment.
• Any previous exposure to tobramycin dry powder for inhalation (TIP).
• Administration of loop diuretics within 7 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 CTBM100C2303, 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 CTBM100C2303, 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 CTBM100C2303, 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 inhaling hypertonic saline at the time of enrollment into CTBM100C2303, butthey must have initiated treatment more than 28 days prior to study drug administration and must be on a stable regimen). In addition, patients should be instructed to inhale their HS at least 30 minutes before their pulmonary function tests (PFT). Patients should be consistent with the timing of taking their HS at home or clinic, prior to their PFT.
• Personal history of abnormal hearing or family history of abnormal hearing other than typical hearing loss associated with the aging process.
• Known abnormal result from any audiology testing (defined as either a unilateral pure-tone audiometry test showing a threshold elevation > 20 dB at any frequency across the frequency range 0.25 kHz to 8 kHz or the absence of emission at the evoked otoacoustic emission test).
• History of sputum culture or throat 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 of more than 60 cc at any time within 30 days prior to study drug administration.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless
of whether there is evidence of local recurrence or metastases,
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termina
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