Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-12

Study Completion Date

2005-02-08

Brief Summary

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The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1: Amikacin Dose 1 + Placebo

Participants will receive a single dose of SLIT™ amikacin at Dose 1 or matching placebo by inhalation on Day 0.

Group Type EXPERIMENTAL

SLIT™ Amikacin

Intervention Type DRUG

Amikacin administered via the Pari LC STAR™ nebulizer.

Placebo

Intervention Type DRUG

Nebulized saline.

Cohort 2: Amikacin Dose 2 + Placebo

Participants will receive a single dose of SLIT™ amikacin at Dose 2 or matching placebo by inhalation on Day 0 upon initiation of Cohort 2.

Group Type EXPERIMENTAL

SLIT™ Amikacin

Intervention Type DRUG

Amikacin administered via the Pari LC STAR™ nebulizer.

Placebo

Intervention Type DRUG

Nebulized saline.

Cohort 3: Amikacin Dose 3 + Placebo

Participants will receive a single dose of SLIT™ amikacin at Dose 3 or matching placebo by inhalation on Day 0 upon initiation of Cohort 3.

Group Type EXPERIMENTAL

SLIT™ Amikacin

Intervention Type DRUG

Amikacin administered via the Pari LC STAR™ nebulizer.

Placebo

Intervention Type DRUG

Nebulized saline.

Interventions

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SLIT™ Amikacin

Amikacin administered via the Pari LC STAR™ nebulizer.

Intervention Type DRUG

Placebo

Nebulized saline.

Intervention Type DRUG

Other Intervention Names

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TR02

Eligibility Criteria

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Inclusion Criteria

* Study participants must produce sputum that is positive for Pseudomonas aeruginosa.
* Confirmed diagnosis of CF (positive sweat chloride \>60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype.
* Forced expiratory volume (FEV1) ≥40% predicted at Screening as calculated by the Knudsen reference equations.
* Clinically stable with no evidence of current pulmonary exacerbation.

Exclusion Criteria

* History of lung transplantation.
* Use of intravenous antibiotics or oral quinolones within 14 days of Screening.
* Use of low dose oral antibiotics (e.g. tetracycline, sulfa) for acne or other conditions within 30 days of Screening.
* Use of systemic corticosteroids (≥20 milligrams \[mg\] of prednisone per day) within 30 days of Screening.
* Initiation of TOBI® (tobramycin), high dose ibuprofen, recombinant human DNase (rhDNase), or macrolide antibiotics within 60 days of Screening.
* History of sputum or throat swab culture yielding Burkholderia cepacia complex within 2 years of Screening or growth of Burkholderia cepacia complex from the sputum or throat swab culture obtained at Screening.
* History of biliary cirrhosis, portal hypertension, or splenomegaly or splenomegaly on physical exam at Screening or enrollment.
* History of daily continuous oxygen supplementation or requirement for more than 2 liter per minute (L/min) at night.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No