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Long Term Safety of Tobramyci...

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

NCT ID: NCT01519661

Last Updated: 2015-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

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This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

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Detailed Description

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Conditions

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Pulmonary Infections Pseudomonas Aeruginosa in Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tobramycin Inhalation Powder (TIP)

Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.

Group Type EXPERIMENTAL

TBM100

Intervention Type DRUG

Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Interventions

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TBM100

Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of Cystic Fibrosis
* FEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation
* Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening

Exclusion Criteria

* History of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening
* Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
* History of hearing loss or chronic tinnitus deemed clinically significant
* Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
* Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic
* Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
* Use of loop diuretics within 7 days prior to study drug administration

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers