Comparison of Amikacin Lung Delivery With Two Nebulizers

NCT ID: NCT02538588

Last Updated: 2015-09-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-12-31

Brief Summary

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Comparison between two modalities of nebulization.

Detailed Description

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Conditions

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Healthy Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nebulizer 1

Nebulization with akita nebulizer

Group Type EXPERIMENTAL

Nebulizer 1

Intervention Type DEVICE

Nebulizer 2

Nebulization with eFlow nebulizer

Group Type ACTIVE_COMPARATOR

Nebulizer 2

Intervention Type DEVICE

Interventions

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Nebulizer 1

Intervention Type DEVICE

Nebulizer 2

Intervention Type DEVICE

Other Intervention Names

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Akita eFlow

Eligibility Criteria

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Inclusion Criteria

* Male healthy subjects
* Cystic fibrosis

Exclusion Criteria

* Kidney failure
* No pregnancy
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Anne-Sophie Aubriot, PT

Role: primary

+3227647020

Other Identifiers

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Akeflow

Identifier Type: -

Identifier Source: org_study_id

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