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Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Primary Purpose

Cystic Fibrosis, Rhinosinusitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sodium chloride 6%
sodium chloride 0,9%
Sponsored by
University of Jena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, chronic rhinosinusitis

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has a confirmed diagnosis of cystic fibrosis based on: 2 positive sweat chloride tests and/or genetic characterization
  • Subject is 8 years of age or older
  • informed consent of the patient or legal representative
  • Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (failure rate <1% e.g. implants, combined oral contraceptives, injectables, some intrauterine devices, sexual abstinence or vasectomised partner)

Exclusion Criteria:

  • Subject has no chronic rhinosinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS-criteria)
  • Subject has a critical condition defined as: forced expiratory volume at one second < 30% and / or arterial oxygen saturation < 93% without O2-substitution; need of O2-substitution
  • Subject had an ENT surgery within 6 months prior to study
  • Subject participates in another clinical trial within 30 days prior to study entry

Sites / Locations

  • Zentrum für Kinder- und Jugendmedizin
  • Universitäts-Kinderklinik
  • Medizinische Klinik Innenstadt
  • Universitätsklinikum Würzburg
  • Zentrum für Kinder- und Jugendmedizin
  • J.W. Goethe Universität - Abtl. Pneumologie
  • Klinik für Kinder- und Jugendmedizin
  • Universitätsklinikum
  • Mukoviszidosezentrum der Friedrich-Schiller-Universität
  • Charité Universitätsmedizin Berlin
  • CF-Zentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sodium chloride 6%

sodium chloride 0,9%

Arm Description

Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).

Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85).

Outcomes

Primary Outcome Measures

Changes in the Sino-nasal-outcome test SNOT-20 adapt CF

Secondary Outcome Measures

Changes in the nasal lavage fluid and in the serological markers of inflammation

Full Information

First Posted
March 12, 2010
Last Updated
November 28, 2014
Sponsor
University of Jena
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1. Study Identification

Unique Protocol Identification Number
NCT01086839
Brief Title
Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Official Title
Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection. In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways. The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Rhinosinusitis
Keywords
Cystic Fibrosis, chronic rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sodium chloride 6%
Arm Type
Experimental
Arm Description
Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).
Arm Title
sodium chloride 0,9%
Arm Type
Placebo Comparator
Arm Description
Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85).
Intervention Type
Drug
Intervention Name(s)
sodium chloride 6%
Intervention Description
one ampoule sodium chloride 6% per day inhalation use for 28 days
Intervention Type
Drug
Intervention Name(s)
sodium chloride 0,9%
Intervention Description
one ampoule sodium chloride 0,9% per day inhalation use for 28 days
Primary Outcome Measure Information:
Title
Changes in the Sino-nasal-outcome test SNOT-20 adapt CF
Time Frame
days 1, 29, 57 and 85
Secondary Outcome Measure Information:
Title
Changes in the nasal lavage fluid and in the serological markers of inflammation
Time Frame
days 1, 29, 57 and 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has a confirmed diagnosis of cystic fibrosis based on: 2 positive sweat chloride tests and/or genetic characterization Subject is 8 years of age or older informed consent of the patient or legal representative Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (failure rate <1% e.g. implants, combined oral contraceptives, injectables, some intrauterine devices, sexual abstinence or vasectomised partner) Exclusion Criteria: Subject has no chronic rhinosinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS-criteria) Subject has a critical condition defined as: forced expiratory volume at one second < 30% and / or arterial oxygen saturation < 93% without O2-substitution; need of O2-substitution Subject had an ENT surgery within 6 months prior to study Subject participates in another clinical trial within 30 days prior to study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Mainz, M.D.
Organizational Affiliation
University of Jena
Official's Role
Study Chair
Facility Information:
Facility Name
Zentrum für Kinder- und Jugendmedizin
City
Heidelberg
State/Province
Baden Würtemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitäts-Kinderklinik
City
Tübingen
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Medizinische Klinik Innenstadt
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Zentrum für Kinder- und Jugendmedizin
City
Greifswald
State/Province
Brandenburg
ZIP/Postal Code
17487
Country
Germany
Facility Name
J.W. Goethe Universität - Abtl. Pneumologie
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinik für Kinder- und Jugendmedizin
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Mukoviszidosezentrum der Friedrich-Schiller-Universität
City
Jena
State/Province
Thüringen
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
CF-Zentrum
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19460681
Citation
Mainz JG, Koitschev A. Management of chronic rhinosinusitis in CF. J Cyst Fibros. 2009 Jun;8 Suppl 1:S10-4. doi: 10.1016/S1569-1993(09)60005-9.
Results Reference
background
PubMed Identifier
19282318
Citation
Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.
Results Reference
background
PubMed Identifier
24594542
Citation
Mainz JG, Schien C, Schiller I, Schadlich K, Koitschev A, Koitschev C, Riethmuller J, Graepler-Mainka U, Wiedemann B, Beck JF. Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial. J Cyst Fibros. 2014 Jul;13(4):461-70. doi: 10.1016/j.jcf.2014.02.005. Epub 2014 Mar 1.
Results Reference
background
PubMed Identifier
24596456
Citation
Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmuller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014.
Results Reference
background
PubMed Identifier
27267518
Citation
Mainz JG, Schumacher U, Schadlich K, Hentschel J, Koitschev C, Koitschev A, Riethmuller J, Prenzel F, Sommerburg O, Wiedemann B, Staab D, Gleiber W, Fischer R, Beck JF, Arnold C; Cooperators. Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis - Results of a multicenter, prospective, randomized, double-blind, controlled trial. J Cyst Fibros. 2016 Nov;15(6):e57-e66. doi: 10.1016/j.jcf.2016.05.003. Epub 2016 Jun 5.
Results Reference
derived

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Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

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