Evaluation of Nebulization and Positive Expiratory Pressure Combination

NCT ID: NCT02535130

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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Conditions

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Cystic Fibrosis Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nebulization combined to positive expiratory pressure

Experimental arm

Group Type EXPERIMENTAL

Positive expiratory pressure

Intervention Type DEVICE

amikacine nebulization

Intervention Type DRUG

Nebulization

Control arm

Group Type ACTIVE_COMPARATOR

amikacine nebulization

Intervention Type DRUG

Interventions

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Positive expiratory pressure

Intervention Type DEVICE

amikacine nebulization

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stable cystic fibrosis patients older than 16 y.o.
* Healthy subjects

Exclusion Criteria

* Kidney failure
* No pregnancy
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Anne-Sophie Aubriot, PT

Role: primary

+3227647020

References

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Aubriot AS, Leal T, Dubus JC, Gohy S, Reychler G. Impact of adding positive expiratory pressure to nebulisation on drug delivery: a comparative study. Physiotherapy. 2025 Feb 13:101772. doi: 10.1016/j.physio.2025.101772. Online ahead of print.

Reference Type DERIVED
PMID: 40199650 (View on PubMed)

Other Identifiers

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NebuPEP

Identifier Type: -

Identifier Source: org_study_id

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