Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections. The prospective placebo controlled cross-over study aims at the evaluation of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
1 x 2,5 ml per day, inhalation use, for 28 days
1 x 2,5 ml per day, inhalation use, for 28 days
Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia, Germany
Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches)
Time frame: day 1, 29, 57 and 85
Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (secondary nasal parameters, general quality of live parameters and total SNOT 20 adapt. CF score)
Time frame: day 1, 29, 57 and 85
Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients)
Time frame: day 1, 29, 57, 85
Changes in the nasal lavage fluid and in the serological markers of inflammation
Time frame: day 1, 29, 57 and 85
Changes in rhinoscopic findings
Time frame: day 1, 29, 57 and 85
Changes in rhinomanometric findings
Time frame: day 1, 29, 27 and 85
Incidence of rhinosinusitic and pulmonary exacerbations during therapy
Time frame: day 1 - 85
Need for decongestants or nasal lavage during treatment
Time frame: day 1 - 85
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