NCT02538588

Brief Summary

Comparison between two modalities of nebulization.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

August 24, 2015

Last Update Submit

September 1, 2015

Conditions

HealthyCystic Fibrosis

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Total urinary concentration of amikacin

    Pharmacokinetic study of the urinary excretion of amikacin after nebulization

    24 hours after the nebulization

Study Arms (2)

Nebulizer 1

EXPERIMENTAL

Nebulization with akita nebulizer

Device: Nebulizer 1

Nebulizer 2

ACTIVE COMPARATOR

Nebulization with eFlow nebulizer

Device: Nebulizer 2

Interventions

Nebulizer 1DEVICE
Also known as: Akita
Nebulizer 1
Nebulizer 2DEVICE
Also known as: eFlow
Nebulizer 2

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male healthy subjects
  • Cystic fibrosis

You may not qualify if:

  • Kidney failure
  • No pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

September 2, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

BE(1)