NCT02201082

Brief Summary

The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

February 20, 2014

Last Update Submit

August 24, 2015

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Urinary excretion of amikacin

    Pharmacokinetic study of the urinary excretion of amikacin after nebulization

    24h after the nebulization

Secondary Outcomes (1)

  • Amikacin concentration into the sputum

    At the end of the nebulization, an expected average of 20 minutes

Study Arms (2)

Nebulization and airway clearance technique

EXPERIMENTAL

nebulization combined to airway clearance

Procedure: Airway clearance techniqueDrug: Amikacin nebulization

Nebulization

ACTIVE COMPARATOR

nebulization

Drug: Amikacin nebulization

Interventions

Airway clearance techniquePROCEDURE
Nebulization and airway clearance technique
Amikacin nebulizationDRUG
NebulizationNebulization and airway clearance technique

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Stable cystic fibrosis patients older than 16 y.o.
  • Pseudomonas aeruginosa colonization
  • Hypersecretion

You may not qualify if:

  • Kidney failure
  • No pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

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

Study Record Dates

First Submitted

February 20, 2014

First Posted

July 25, 2014

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2015

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

BE(1)