Lung Bioavailability With Continuous or Discontinuous Nebulization

Healthy Subjects Clinical Trial

Official title:

EFFECT OF DRUG TARGETING NEBULIZATION ON LUNG DELIVERY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913184
• Other study ID #: AKITA continuous
• Status: Completed
• Phase: N/A
• First received: July 29, 2013
• Last updated: July 30, 2013
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• no lung disease

• no allergy

Exclusion Criteria:

• smoker

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• AKITA

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung bioavailability by urinary monitoring		24h after the nebulization	No
Secondary	Duration of the nebulization		After the nebulization	No