Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms (KPNSI)
|ClinicalTrials.gov Identifier: NCT02311140|
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : October 25, 2016
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 potentiator. The focus will be given on changes in epithelial lining fluid inflammatory markers from CF upper airways sampled by nasal lavage.
The program is subdivided into a part A assessing inflammatory markers in NL and sinonasal symptoms longitudinally from pre-treatment to months with the new therapy.
Part B will only be performed in a smaller subgroup and assess inflammatory markers in NL every second day in the first month of treatment and then every week until the end of month 3 with Kalydeco™ therapy.
|Condition or disease||Intervention/treatment|
|Inflammatory Changes in Epithelial Lining Fluid Sampled Non-invasively by Nasal Lavage in CF Patients With G551D Receiving Kalydeco||Other: nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||January 2018|
|Cystic Fibrosis patients with G551D mutation||Other: nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms|
- Changes in concentration of inflammatory markers [ Time Frame: 3 yrs ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311140
|Contact: Jochen G Mainz, PHD, MDfirstname.lastname@example.org|
|Jena University Hospital, CF Center||Recruiting|
|Jena, Germany, 07743|
|Contact: Jochen G Mainz, MD, PD +493641938425 email@example.com|