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

This study is currently recruiting participants.
Verified October 2016 by PD Dr. Jochen G. Mainz, University of Jena
Sponsor:
ClinicalTrials.gov Identifier:
NCT02311140
First Posted: December 8, 2014
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Innsbruck, Austria
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena
  Purpose

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 Intervention
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
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

Resource links provided by NLM:


Further study details as provided by PD Dr. Jochen G. Mainz, University of Jena:

Primary Outcome Measures:
  • Changes in concentration of inflammatory markers [ Time Frame: 3 yrs ]

Biospecimen Retention:   Samples Without DNA
Nasal lavage

Estimated Enrollment: 10
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)
Groups/Cohorts Assigned Interventions
Cystic Fibrosis patients with G551D mutation Other: nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CF patients with G551D mutation receiving Kalydeco
Criteria

Inclusion Criteria:

  • G551D and Kalydeco therapy

Exclusion Criteria:

  • no G551D
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311140


Contacts
Contact: Jochen G Mainz, PHD, MD +493641938425 jochen.mainz@med.uni-jena.de

Locations
Germany
Jena University Hospital, CF Center Recruiting
Jena, Germany, 07743
Contact: Jochen G Mainz, MD, PD    +493641938425    jochen.mainz@med.uni-jena.de   
Sponsors and Collaborators
University of Jena
University of Innsbruck, Austria
  More Information

Responsible Party: PD Dr. Jochen G. Mainz, Head of CF Center, Pediatric Pulmonology, University of Jena
ClinicalTrials.gov Identifier: NCT02311140     History of Changes
Other Study ID Numbers: UKJ-IVA-Nasal
First Submitted: December 4, 2014
First Posted: December 8, 2014
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by PD Dr. Jochen G. Mainz, University of Jena:
cystic fibrosis
nasal lavage
inflammation
Interleukin (IL)-6
IL-8
pulmonary function

Additional relevant MeSH terms:
Inflammation
Sinusitis
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ivacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action