A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.
- Conditions
- Pseudomonas aeruginosa infection in cystic fibrosis patientsMedDRA version: 12.1Level: LLTClassification code 10021860Term: Infection pseudomonas aeruginosa
- Registration Number
- EUCTR2008-004764-39-BG
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 100
Main inclusion criteria (refer to full protocol for comprehensive list)
• Written informed consent given by adult subjects or by the parents/legal guardian on behalf of the subject in
combination with the subject’ s assent, if capable of assenting, before any assessment is performed.
• Completed all visits in study CTBM100C2303, and visit 4 of CTBM100C2303 took place not more than 5 days
before enrollment into this study.
• Able to comply with all protocol requirements.
• Use of an effective means of contraception in women of childbearing potential.
• Clinically stable in the opinion of the investigator to be treated according to this protocol.
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)
• Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and
the enrollment into this study.
• Any use of systemic anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303
and the enrollment into this study.
• 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 (except for study medication in
CTBM100C2303).
• Any previous exposure to tobramycin dry powder for inhalation (TIP), with the exception of study medication
for study CTMB100C2303.
• Administration of loop diuretics within 7 days prior to study drug administration.
• Initiation of treatment with chronic macrolide therapy between the termination of the core trial CTMB100C2303 and the enrollment into this study (subjects may be taking chronic macrolide therapy at the time of enrollment into CTBM100C2303E1, but they must have initiated treatment more than 28 days prior to study drug administration for CTBM100C2303 and the dosage/regimen must remain stable throughout the study).
• Initiation of treatment with dornase alpha between the termination of the core trial CTMB100C2303 and the enrollment into this study (subjects may be taking dornase alpha at the time of enrollment into CTBM100C2303E1, but they must have initiated treatment more than 28 days prior to study drug administration
for CTBM100C2303 and the dosage/regimen must remain stable throughout the study).
• Initiation of treatment with inhaled steroids (or increased dose) between the termination of the core trial CTMB100C2303 and the enrollment into this study (subjects may be taking inhaled steroids at the time of enrollment into CTBM100C2303E1, but they must have initiated treatment more than 28 days prior to study drug administration for CTBM100C2303 and the dosage/regimen must remain stable throughout the study).
• Initiation of treatment with inhaled hypertonic saline (HS) between the termination of the core trial
CTMB100C2303 and the enrollment into this study (subjects may be inhaling hypertonic saline at the time of
enrollment into CTBM100C2303E1, but they must have initiated treatment more than 28 days prior to study
drug administration for CTBM100C2303 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.
• 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 for CTBM100C2303 and/or sputum culture yielding B. cepacia at screening for
CTBM100C2303 or at enrollment
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