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NCT Number: NCT01086839

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

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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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Nose Diseases Otorhinolaryngologic Diseases Pancreatic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinosinusitis Sinusitis

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentrum für Kinder- und Jugendmedizin, Heidelberg, Baden Würtemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium chloride 6%

Drug
  • one ampoule sodium chloride 6% per day
  • inhalation use
  • for 28 days

Sodium Chloride 0,9%

Drug
  • one ampoule sodium chloride 0,9% per day
  • inhalation use
  • for 28 days

Primary outcomes

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

    Time frame: days 1, 29, 57 and 85

Secondary outcomes

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

    Time frame: days 1, 29, 57 and 85

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2010
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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