Evaluation of Nebulization and Positive Expiratory Pressure Combination

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02535130
• Other study ID #: NebuPEP
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2015
• Last updated: August 16, 2016
• Start date: August 2015
• Est. completion date: June 2018

Study information

• Verified date: August 2016
• 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 55 Years

Eligibility

Inclusion Criteria:

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

• Healthy subjects

Exclusion Criteria:

• Kidney failure

• No pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Healthy Subjects

Intervention

Device:
• Positive expiratory pressure

Drug:
• amikacine nebulization

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	Urinary excretion of amikacin	Pharmacokinetic study of the urinary excretion of amikacin after nebulization	24 hours after the nebulization	No
Secondary	breathing pattern	recoding of frequency and tidal volume during the nebulization	participants will be recorded for the duration of the nebulization, an expected average of 15 minutes	No