Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-27

Study Completion Date

2017-04-10

Brief Summary

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The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung disease.

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Detailed Description

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This study was terminated prematurely. The reason for trial termination was challenge with enrollment and patient recruitment. A significant decrease in the eligible patient population had been identified as main driver.

Conditions

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Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tobramycin ALL

300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)twice a day (BID) 28days on / 28 days off

Group Type EXPERIMENTAL

TIS or TIP

Intervention Type DRUG

300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)

Interventions

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TIS or TIP

300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of CF
* Patients with elevated LCI of ≥ 7.5 at screening
* Patients with FEV1 of ≥ 50% predicted at screening
* Use of inhaled Tobramycin in a 28 days on / off regimen in the past 3 months before screening
* chronic lung Infection with Pseudomonas aeruginosa

Exclusion Criteria

* Patients who are regularly receiving more than one class of inhaled anti-pseudomonal antibiotic
* Patients who have used oral or intravenous anti-pseudomonal antibiotics within 28 days prior to on-phase of study drug
* Pregnant or nursing (lactating) women
* Change in dose, formulation or strength of the study drug in the past treatment cycle before screening
* History of hearing loss or chronic tinnitus
* Infection with Burkholderia cenocepacia complex

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No