Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005574

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005574
  •   2014/04/02
  •   2010/03/12
  •   yes
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Secondary IDs

  •   NCT01086839  (ClinicalTrials.gov)
  •   NaCl 6.0%-nasal-CF  (University of Jena)
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Health Condition or Problem studied

  •   Cystic Fibrosis
  •   Rhinosinusitis
  •   J32 -  Chronic sinusitis
  •   E84 -  Cystic fibrosis
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Interventions/Observational Groups

  •   Drug: sodium chloride 6%
  •   Drug: sodium chloride 0,9%
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
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Primary Outcome

- Changes in the Sino-nasal-outcome test SNOT-20 adapt CF; time frame: days 1, 29, 57 and 85

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Secondary Outcome

- Changes in the nasal lavage fluid and in the serological markers of inflammation; time frame: days 1, 29, 57 and 85

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/03/31
  •   69
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   no maximum age
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Additional 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)

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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

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Addresses

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    • University of Jena
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    • University of Jena
    • Jochen Mainz, M.D. 
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    • Jochen G Mainz, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Mainz JG, Koitschev A. Management of chronic rhinosinusitis in CF. J Cyst Fibros. 2009 Jun;8 Suppl 1:S10-4.; 19460681
  •   Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. Epub 2009 Mar 11.; 19282318
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.