Evaluation of Nebulization and Positive Expiratory Pressure Combination

August 16, 2016 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
        • Principal Investigator:
          • Anne-Sophie Aubriot, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable cystic fibrosis patients older than 16 y.o.
  • Healthy subjects

Exclusion Criteria:

  • Kidney failure
  • No pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulization combined to positive expiratory pressure
Experimental arm
Device: Positive expiratory pressure
Drug: amikacine nebulization
Active Comparator: Nebulization
Control arm
Drug: amikacine nebulization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary excretion of amikacin
Time Frame: 24 hours after the nebulization
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
24 hours after the nebulization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breathing pattern
Time Frame: participants will be recorded for the duration of the nebulization, an expected average of 15 minutes
recoding of frequency and tidal volume during the nebulization
participants will be recorded for the duration of the nebulization, an expected average of 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NebuPEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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