Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms (KPNSI)
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.
|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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms|
- Changes in concentration of inflammatory markers [ Time Frame: 3 yrs ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
|Cystic Fibrosis patients with G551D mutation||Other: nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms|
Please refer to this study by its ClinicalTrials.gov identifier: 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|