Status:
COMPLETED
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-21 years
Phase:
PHASE3
Brief Summary
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
Eligibility Criteria
Inclusion
- Written informed consent given by adults or by the parents/legal guardian in combination with the patient's assent, if capable of assenting, before any assessment was performed
- Confirmed diagnosis of Cystic Fibrosis (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.
- Forced Expiratory Volume in one second (FEV1) at screening must have been ≥25% and ≤80% of normal predicted values for age, sex, and height based on Knudson criteria
- P. aeruginosa must have been 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 or provide a deep throat cough swab at screening
- Able to comply with all protocol requirements
- 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
Exclusion
- FEV1 at baseline (Visit 2) \<25% or \>80% of normal predicted values for age, sex, and height based on Knudson criteria, and/or FEV1 at baseline (Visit 2) deviated 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, blood urea nitrogen (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
- Initiation of treatment with dornase alfa within 28 days prior to study drug administration
- Initiation of treatment with inhaled steroids (or increased dose) within 28 days prior to study drug administration
- Initiation of treatment with inhaled hypertonic saline (HS) within 28 days prior to study drug administration
- 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 puretone 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 mL 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 evidence of local recurrence or metastases
- Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
- Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they used two reliable birth control methods
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00918957
Start Date
June 1 2009
End Date
May 1 2011
Last Update
October 3 2012
Active Locations (24)
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1
Novartis Investigative Site
Pleven, Bulgaria
2
Novartis Investigative Site
Plovdiv, Bulgaria
3
Novartis Investigative Site
Sofia, Bulgaria
4
Novartis Investigative Site
Varna, Bulgaria