Lung Bioavailability With Continuous or Discontinuous Nebulization

July 30, 2013 updated by: G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

EFFECT OF DRUG TARGETING NEBULIZATION ON LUNG DELIVERY

To compare the continuous and sicontinuous delivery of drug with AKITA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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
        • Cliniques universitaires Saint-Luc

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • no lung disease
  • no allergy

Exclusion Criteria:

  • smoker

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Continuous nebulization
Continuous nebulization with AKITA
Device: AKITA
EXPERIMENTAL: Discontinuous nebulization
Discontinuous nebulization with AKITA
Device: AKITA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lung bioavailability by urinary monitoring
Time Frame: 24h after the nebulization
24h after the nebulization

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of the nebulization
Time Frame: After the nebulization
After the nebulization

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (ESTIMATE)

July 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • AKITA continuous

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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Locations

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