NCT01913184

Brief Summary

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

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

Timeline
Completed

Started Apr 2012

Shorter than P25 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

April 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1 month

First QC Date

July 29, 2013

Last Update Submit

July 30, 2013

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Lung bioavailability by urinary monitoring

    24h after the nebulization

Secondary Outcomes (1)

  • Duration of the nebulization

    After the nebulization

Study Arms (2)

Continuous nebulization

ACTIVE COMPARATOR

Continuous nebulization with AKITA

Device: AKITA

Discontinuous nebulization

EXPERIMENTAL

Discontinuous nebulization with AKITA

Device: AKITA

Interventions

AKITADEVICE
Continuous nebulizationDiscontinuous nebulization

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no lung disease
  • no allergy

You may not qualify if:

  • smoker

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, Aubriot AS, Masquelier J, Muccioli GG, Liistro G. Effect of drug-targeting nebulization on lung delivery. Arch Bronconeumol. 2014 Nov;50(11):500-1. doi: 10.1016/j.arbres.2013.10.014. Epub 2013 Dec 29. No abstract available. English, Spanish.

    PMID: 24380752DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

April 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

BE(1)