NCT02535130

Brief Summary

The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

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
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 24, 2015

Last Update Submit

August 16, 2016

Conditions

Cystic FibrosisHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Urinary excretion of amikacin

    Pharmacokinetic study of the urinary excretion of amikacin after nebulization

    24 hours after the nebulization

Secondary Outcomes (1)

  • breathing pattern

    participants will be recorded for the duration of the nebulization, an expected average of 15 minutes

Study Arms (2)

Nebulization combined to positive expiratory pressure

EXPERIMENTAL

Experimental arm

Device: Positive expiratory pressureDrug: amikacine nebulization

Nebulization

ACTIVE COMPARATOR

Control arm

Drug: amikacine nebulization

Interventions

Positive expiratory pressureDEVICE
Nebulization combined to positive expiratory pressure
amikacine nebulizationDRUG
NebulizationNebulization combined to positive expiratory pressure

Eligibility Criteria

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

You may qualify if:

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

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

Related Publications (1)

  • Aubriot AS, Leal T, Dubus JC, Gohy S, Reychler G. Impact of adding positive expiratory pressure to nebulisation on drug delivery: a comparative study. Physiotherapy. 2025 Feb 13:101772. doi: 10.1016/j.physio.2025.101772. Online ahead of print.

    PMID: 40199650DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

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

August 28, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

June 1, 2018

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

BE(1)