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      Nasal saline as a placebo in a rhinosinusitis study

      1 , 2

      Drug Design, Development and Therapy

      Dove Medical Press

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          Abstract

          Dear editor I read with interest Mainz et al’s article in the February issue of your journal.1 The authors concluded that sinonasal inhalation of vibrating antibiotic aerosols appears promising for reducing pathogen colonization of paranasal sinuses and for control of symptoms in patients with cystic fibrosis. We have an objection to their study methods. It is well known that isotonic saline solution nasal washing facilitates nasal drainage and cleans the airway of any postnasal discharge (including allergens); furthermore, it can be effective when applied appropriately.2–6 Isotonic saline solution is applied (five dropperfuls in each nostril) at least four times a day until the symptomatology subsides.2 In addition, isotonic saline solution irrigation has been found to reduce inflammatory mediators (histamine, prostaglandin D2, and leukotriene C4) and allergens in nasal secretions.7 For these reasons, nasal washing with saline is effective against pathologies of the upper respiratory tract that occur via inflammatory mediators, namely, the common cold, acute and chronic sinusitis, and, in particular, rhinitis.7 As a result, nasal saline, administered with the correct technique, can be as effective as nasal drugs; therefore, it cannot be used as a placebo in a rhinosinusitis study.

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          Most cited references 13

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          Effect of dornase alfa on inflammation and lung function: potential role in the early treatment of cystic fibrosis.

          Dornase alfa has been shown to reduce markers of inflammation and neutrophil-associated metalloproteinases in cystic fibrosis (CF), suggesting a potential benefit from use of this therapy early in the disease. However, observational studies indicate that dornase alfa is often reserved for "sicker" patients. A 2-year, early intervention study of dornase alfa in CF patients with early lung disease demonstrated significant improvements in lung function and risk of exacerbation compared to placebo. A more recent analysis, using the database of the large observational Epidemiologic Study of Cystic Fibrosis (ESCF), found that initiation of dornase alfa has the potential to alter the course of CF by decreasing the rate of lung function decline in children and adults. These encouraging results, possibly linked to indirect effects on inflammation, suggest a greater role for dornase alfa therapy in the early treatment of CF, where it may help preserve lung function and potentially extend survival. Copyright © 2011 European Cystic Fibrosis Society. All rights reserved.
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            Nasal hyperthermia and simple irrigation for perennial rhinitis. Changes in inflammatory mediators.

             J W Georgitis (1994)
            Local nasal hyperthermia or inhalation of heated water vapor is often recommended as a home remedy for various rhinitis disorders such as the common cold and allergic rhinitis. Inhaled heated vapor treatments and simple saline solution nasal irrigation were investigated for their effect on inflammatory mediator production in nasal secretions. Three treatments were given for nasal irrigation: heated water particles (large particle water vapor) at 43 degrees C, heated molecular water vapor (molecular water vapor) at 41 degrees C, and simple saline solution nasal irrigation. Nasal washes were done before each treatment (baseline), immediately after treatments, and at 30 min, 2, 4, and 6 h. Histamine, prostaglandin D2, and leukotriene C4 (LTC4) concentrations were measured in nasal secretions and compared with baseline values. Thirty symptomatic patients with active perennial allergic rhinitis underwent three treatments at weekly intervals. Nasal histamine concentrations fell substantially with the nasal irrigation (p < 0.01 immediately posttreatment and at 30 min; p < 0.05 at 2, 4, and 6 h). Large particle vapor also reduced histamine concentrations for up to 4 h posttreatment compared with baseline values (p < 0.05). Alternatively, molecular water vapor did not alter nasal histamine concentrations. Surprisingly, the three treatments did not alter prostaglandin D2 concentrations over the 6 h. Leukotriene C4 concentrations fell briefly after the large particle treatment but did not with the molecular water vapor. With saline solution irrigation, LTC4 concentrations in nasal secretions were lower than baseline at 30 min to 4 h after a treatment (p < 0.05). This study demonstrated the usefulness of large particle vapor treatment and saline solution irrigation in reducing inflammatory mediators in nasal secretions and indirectly supports the clinical efficacy of these treatments for chronic rhinitis.
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              Influences of nasal lavage collection-, processing- and storage methods on inflammatory markers--evaluation of a method for non-invasive sampling of epithelial lining fluid in cystic fibrosis and other respiratory diseases.

              Non-invasive sampling of airway epithelial-lining-fluid by nasal lavage (NL) is an emerging method to monitor allergy, infection and inflammation in patients with respiratory diseases. However, the influences of collection-, processing- and storage-methods have not been sufficiently evaluated and standardized. Influences of repeated NL, centrifugation setups, repeated freezing and thawing, and protease inhibitors on mediator concentration were evaluated in healthy controls and CF patients, which serve as a model for chronic bacterial infection and inflammation. Polymorphonuclear leukocyte elastase (NE)/myeloperoxidase (MPO)/interleukin (IL)-1/IL-6/IL-8 and tumour necrosis factor alpha (TNF) concentrations were measured using ELISA and Multiplex Bead-Arrays. NL-repetition within 0.5-4h markedly decreased NE, IL-8 and MPO-concentrations for up to 70%. NL centrifugation up to 250×g for cellular differentiation did not significantly influence mediator concentration in native and processed NL fluid. NL freezing and thawing markedly decreased IL-8 and MPO concentrations by up to 50% while NE remained stable. In contrast to preceding reports, storing at -70°C for ≥5 years led to significantly reduced mediator concentrations in NL compared to contemporary analyses, being most pronounced for IL-1β, IL-6 and TNFa. Storing of samples in the presence of protease inhibitors led to an increase in marker concentration for IL-8 (+27%) and MPO (+15%) even after one year of storage. NL is an easy and robust technique for inflammation monitoring of the upper airways. For the first time we have shown that diagnostic NL should be performed only once daily to get comparable results. Whereas NL-fluid can be stored unprocessed at -70°C for cytokine analysis over 1-2 years with protease inhibitors supporting stability, ≥5 years storage as well as repeated freezing and thawing should be avoided. Copyright © 2013 Elsevier B.V. All rights reserved.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2014
                20 August 2014
                : 8
                : 1135-1137
                Affiliations
                [1 ]Division of Neonatology, School of Medicine, Inonu University, Malatya, Turkey
                [2 ]Division of Pediatric Allergy Department of Pediatrics, School of Medicine, Inonu University, Malatya, Turkey
                Cystic Fibrosis Centre, Jena University Hospital, Jena, Germany
                Author notes
                Correspondence: Ferhat Catal, Department of Pediatrics, Division of Pediatric Allergy, School of Medicine, Inonu University, Seyrentepe Mah, Florya Park Sitesi, No:6, 44000, Malatya, Turkey, Email ferhatcatal@ 123456gmail.com
                Correspondence: Jochen G Mainz, Pediatric Pulmonology, Cystic Fibrosis Centre for Children and Adults, Jena University Hospital, Kochstrasse 2, 07745 Jena, Germany, Tel +49 3641 938 425, Fax +49 3641 938 314, Email jochen.mainz@ 123456med.uni-jena.de
                Article
                dddt-8-1135
                10.2147/DDDT.S69627
                4149336
                25187695
                © 2014 Karadag and Catal. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Letter

                Pharmacology & Pharmaceutical medicine

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