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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dornase alfa | Experimental | 28 days of sinonasal inhalation (Pari Sinus) |
|
| isotonic saline | Placebo Comparator | 28 days of sinonasal inhalation (Pari Sinus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dornase alfa (Pulmozyme) | Drug | 1 x 2,5 ml per day, inhalation use, for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | day 1, 29, 57 and 85 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | day 1, 29, 57 and 85 | |
| Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Mainz, M.D. | University of Jena | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Kinderklinik | Tübingen | Baden-Würtemberg | 72076 | Germany | ||
| Mukoviszidosezentrum der Friedrich-Schiller-Universität |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25081561 | Background | Mainz JG, Michl R, Arnold C. Response to Karadag. J Cyst Fibros. 2014 Sep;13(5):602-3. doi: 10.1016/j.jcf.2014.07.005. Epub 2014 Jul 28. No abstract available. | |
| 24594542 | Result | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C568813 | dornase alfa |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| isotonic saline | Drug | 1 x 2,5 ml per day, inhalation use, for 28 days |
|
| day 1, 29, 57, 85 |
| Changes in the nasal lavage fluid and in the serological markers of inflammation | day 1, 29, 57 and 85 |
| Changes in rhinoscopic findings | day 1, 29, 57 and 85 |
| Changes in rhinomanometric findings | day 1, 29, 27 and 85 |
| Incidence of rhinosinusitic and pulmonary exacerbations during therapy | day 1 - 85 |
| Need for decongestants or nasal lavage during treatment | day 1 - 85 |
| Jena |
| Thuringia |
| 07740 |
| Germany |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D017670 |
| Sodium Compounds |