NCT02451501

Brief Summary

To compare deposition in two different positions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 7, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1 month

First QC Date

May 7, 2015

Last Update Submit

April 19, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Lung deposition by scintigraphy

    1 day

Study Arms (2)

Lying

EXPERIMENTAL

Nebulization in lying position

Device: AKITA

Sitting

ACTIVE COMPARATOR

Nebulization in sitting position

Device: AKITA

Interventions

AKITADEVICE
LyingSitting

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Free of respiratory disease

You may not qualify if:

  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

  • Reychler G, San Miguel-Pagola M, Aubriot AS, Herrero-Cortina B, Lecocq V, Hesse M, Liistro G, Jamar F. Targeted Lung Deposition From Nebulization Is Not Improved in the Lateral Decubitus Position in Healthy Volunteers. Respir Care. 2019 Dec;64(12):1537-1544. doi: 10.4187/respcare.06978. Epub 2019 Sep 10.

    PMID: 31506338DERIVED

Study Design

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

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 22, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

BE(1)