NCT01877304

Brief Summary

To compare deposition between two modalities of nebulization

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

May 29, 2013

Last Update Submit

June 10, 2013

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Lung deposition by scintigraphy

    After 15 minutes

Secondary Outcomes (1)

  • Regional deposition by scintigraphy

    After 15 minutes

Study Arms (2)

AKITA with program central deposition

EXPERIMENTAL

Nebulization for central deposition

Device: AKITA

AKITA with program for peripheral deposition

ACTIVE COMPARATOR

Nebulization for peripheral deposition

Device: AKITA

Interventions

AKITADEVICE
AKITA with program central depositionAKITA with program for peripheral deposition

Eligibility Criteria

Age18 Years - 60 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

Study Design

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

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 13, 2013

Study Start

June 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

BE(1)