Status:
COMPLETED
Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms
Lead Sponsor:
University of Jena
Collaborating Sponsors:
Medical University Innsbruck
Conditions:
Inflammatory Changes in Epithelial Lining Fluid Sampled Non-invasively by Nasal Lavage in CF Patients With G551D Receiving Kalydeco
Eligibility:
All Genders
6+ years
Brief Summary
The aim of the proposed trial in assessment of effects of Kalydeco™ treatment on sinonasal involvement in CF patients with at least one mutation of G551D receiving a new therapy with the CFTR potentia...
Detailed Description
Enrollment of Patients In this longitudinal trial, 10 CF patients with a G551D mutation, newly receiving ivacaftor 150 mg bid, as approved (1), were included in the Jena (Germany) and Innsbruck (Austr...
Eligibility Criteria
Inclusion
- G551D and Kalydeco therapy
Exclusion
- no G551D
Key Trial Info
Start Date :
July 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02311140
Start Date
July 1 2012
End Date
December 1 2018
Last Update
July 15 2021
Active Locations (1)
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1
Jena University Hospital, CF Center
Jena, Germany, 07743