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Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms (KPNSI)

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ClinicalTrials.gov Identifier: NCT02311140
Recruitment Status : Unknown
Verified October 2016 by PD Dr. Jochen G. Mainz, University of Jena.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
University of Innsbruck, Austria
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena

Tracking Information
First Submitted Date December 4, 2014
First Posted Date December 8, 2014
Last Update Posted Date October 25, 2016
Study Start Date July 2012
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2014)
Changes in concentration of inflammatory markers [ Time Frame: 3 yrs ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms
Official Title Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms
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 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Nasal lavage
Sampling Method Non-Probability Sample
Study Population CF patients with G551D mutation receiving Kalydeco
Condition Inflammatory Changes in Epithelial Lining Fluid Sampled Non-invasively by Nasal Lavage in CF Patients With G551D Receiving Kalydeco
Intervention Other: nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms
Study Groups/Cohorts Cystic Fibrosis patients with G551D mutation
Intervention: Other: nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 4, 2014)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2018
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • G551D and Kalydeco therapy

Exclusion Criteria:

  • no G551D
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02311140
Other Study ID Numbers UKJ-IVA-Nasal
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PD Dr. Jochen G. Mainz, University of Jena
Study Sponsor University of Jena
Collaborators University of Innsbruck, Austria
Investigators Not Provided
PRS Account University of Jena
Verification Date October 2016