Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis — Results of a multicenter, prospective, randomized, double-blind, controlled trial

Journal of Cystic Fibrosis

Volumn 15, Issue 6, 2016, Pages e57-e66

  Mainz, Jochen G ^a   Schumacher, Ulrike ^a   Schädlich, Katja ^a   Hentschel, Julia ^a,n   Koitschev, Christiane ⁱ   Koitschev, Assen ⁱ   Riethmüller, Joachim ^j   Prenzel, Freerk ^b   Sommerburg, Olaf ^h   Wiedemann, Bärbel ^k   Staab, Doris ^l   Gleiber, Wolfgang ^c   Fischer, Rainald ^m   Beck, James F ^a   Arnold, Christin ^a   Schien, Claudia ^a   Nader, Anika ^a   Henn, Constance ^b   Smaczny, Christina ^c   Werner, Claudius ^d   Hebestreit, Helge ^e   Heuer, Hans Eberhard ^f   Schmidt, Sebastian ^g   Eichhorn, Corinna ^a   Schiller, Isabella ^a   Roessler, Andrea ^a   Baumann, Ingo ^h   more..

^a JENA UNIVERSITY HOSPITAL   (Germany)

^b UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^c UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^d UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^e UNIVERSITY HOSPITAL WÜRZBURG   (Germany)

^f CF Center   (Germany)

^g UNIVERSITY MEDICINE GREIFSWALD   (Germany)

^h UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

ⁱ KLINIKUM STUTTGART   (Germany)

^j UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^k DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^l CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^m UNIVERSITY OF MUNICH   (Germany)

ⁿ UNIVERSITY OF LEIPZIG   (Germany)

more..

Author keywords

Hypertonic saline; Inflammation; Nasal lavage; Rhinomanometry; Sino Nasal Outcome Test 20; Sodium chloride

Indexed keywords

DORNASE ALFA; INTERLEUKIN 1BETA; INTERLEUKIN 6; INTERLEUKIN 8; ISOTONIC SOLUTION; LEUKOCYTE ELASTASE; PROTEINASE INHIBITOR; SODIUM CHLORIDE;

ADULT; ARTICLE; BURNING SENSATION; CHRONIC RHINOSINUSITIS; CONTROLLED STUDY; DRUG EFFECT; DRUG TOLERABILITY; EPISTAXIS; FEMALE; HUMAN; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NASAL LAVAGE; OTALGIA; OUTCOME ASSESSMENT; PAIN; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOMANOMETRY; SINO NASAL OUTCOME TEST 20; SYMPTOM ASSESSMENT; ADOLESCENT; CHILD; CHRONIC DISEASE; CLINICAL TRIAL; COMPLICATION; CYSTIC FIBROSIS; DRUG MONITORING; INHALATIONAL DRUG ADMINISTRATION; LUNG FUNCTION TEST; PROCEDURES; PSYCHOLOGY; RHINITIS; SINUSITIS; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; CHILD; CHRONIC DISEASE; CYSTIC FIBROSIS; DRUG MONITORING; FEMALE; HUMANS; MALE; NASAL LAVAGE; QUALITY OF LIFE; RESPIRATORY FUNCTION TESTS; RHINITIS; RHINOMANOMETRY; SALINE SOLUTION, HYPERTONIC; SINUSITIS; TREATMENT OUTCOME;

EID: 84992411241     PISSN: 15691993     EISSN: 18735010     Source Type: Journal    
DOI: 10.1016/j.jcf.2016.05.003     Document Type: Article

References (28)

1. [1] King, V.V., Upper respiratory disease, sinusitis, and polyposis. Clin Rev Allergy 9:1–2 (1991), 143–157.
2. [2] Muhlebach, M.S., Miller, M.B., Moore, C., Wedd, J.P., Drake, A.F., Leigh, M.W., Are lower airway or throat cultures predictive of sinus bacteriology in cystic fibrosis?. Pediatr Pulmonol 41:5 (2006), 445–451.
3. [3] Moss, R.B., King, V.V., Management of sinusitis in cystic fibrosis by endoscopic surgery and serial antimicrobial lavage. Reduction in recurrence requiring surgery. Arch Otolaryngol Head Neck Surg 121:5 (1995), 566–572.
4. [4] Mainz, J.G., Koitschev, A., Management of chronic rhinosinusitis in CF. J Cyst Fibros 8:S1 (2009), 10–14.
5. [5] Aanaes, K., Bacterial sinusitis can be a focus for initial lung colonisation and chronic lung infection in patients with cystic fibrosis. J Cyst Fibros 12:S2 (2013), 1–20.
6. [6] Mak, G.K., Henig, N.R., Sinus disease in cystic fibrosis. Clin Rev Allergy Immunol 21:1 (2001), 51–63.
7. [7] Eggesbo, H.B., Sovik, S., Dolvik, S., Kolmannskog, F., CT characterization of inflammatory paranasal sinus disease in cystic fibrosis. Acta Radiol 43:1 (2002), 21–28.
8. [8] Berkhout, M.C., van Rooden, C.J., Rijntjes, E., Fokkens, W.J., el Bouazzaoui, L.H., Heijerman, H.G., Sinonasal manifestations of cystic fibrosis: a correlation between genotype and phenotype?. J Cyst Fibros 13:4 (2014), 442–448.
9. [9] Schraven, S.P., Wehrmann, M., Wagner, W., Blumenstock, G., Koitschev, A., Prevalence and histopathology of chronic polypoid sinusitis in pediatric patients with cystic fibrosis. J Cyst Fibros 10:3 (2011), 181–186.
10. [10] Babinski, D., Trawinska-Bartnicka, M., Rhinosinusitis in cystic fibrosis: not a simple story. Int J Pediatr Otorhinolaryngol 72:5 (2008), 619–624.
11. [11] St Martin, M.B., Hitzman, C.J., Wiedmann, T.S., Rimell, F.L., Deposition of aerosolized particles in the maxillary sinuses before and after endoscopic sinus surgery. Am J Rhinol 21:2 (2007), 196–197.
12. [12] Möller, W., Saba, G.K., Haussinger, K., Becker, S., Keller, M., Schuschnig, U., Nasally inhaled pulsating aerosols: lung, sinus and nose deposition. Rhinology 49:3 (2011), 286–291.
13. [13] Möller, W., Schuschnig, U., Khadem Saba, G., Meyer, G., Junge-Hulsing, B., Keller, M., et al. Pulsating aerosols for drug delivery to the sinuses in healthy volunteers. Otolaryngol Head Neck Surg 142:3 (2010), 382–388.
14. [14] Möller, W., Schuschnig, U., Meyer, G., Mentzel, H., Keller, M., Ventilation and drug delivery to the paranasal sinuses: studies in a nasal cast using pulsating airflow. Rhinology 46:3 (2008), 213–220.
15. [15] Mainz, J.G., Schien, C., Schiller, I., Schädlich, K., Koitschev, A., Koitschev, C., et al. Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial. J Cyst Fibros 13:4 (2014), 461–470.
16. [16] Mainz, J.G., Schiller, I., Ritschel, C., Mentzel, H.J., Riethmüller, J., Koitschev, A., et al. Sinonasal inhalation of dornase alfa in CF: a double-blind placebo-controlled cross-over pilot trial. Auris Nasus Larynx 38:2 (2011), 220–227.
17. [17] Fokkens, W.J., Lund, V.J., Mullol, J., Bachert, C., Alobid, I., Baroody, F., et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology 50:1 (2012), 1–12.
18. [18] Hentschel, J., Müller, U., Doht, F., Fischer, N., Böer, K., Sonnemann, J., et al. 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. J Immunol Methods 404 (2014), 41–51.
19. [19] Wark, P., McDonald, V.M., Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev, 2, 2009, CD001506.
20. [20] Donaldson, S.H., Bennett, W.D., Zeman, K.L., Knowles, M.R., Tarran, R., Boucher, R.C., Mucus clearance and lung function in cystic fibrosis with hypertonic saline. N Engl J Med 354:3 (2006), 241–250.
21. [21] Elkins, M.R., Robinson, M., Rose, B.R., Harbour, C., Moriarty, C.P., Marks, G.B., et al. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med 354:3 (2006), 229–240.
22. [22] Baumann, I., Blumenstock, G., Zalaman, I.M., Praetorius, M., Klingmann, C., Sittel, C., et al. Impact of gender, age, and comorbidities on quality of life in patients with chronic rhinosinusitis. Rhinology 45:4 (2007), 268–272.
23. [23] Piccirillo, J.F., Merritt, M.G. Jr., Richards, M.L., Psychometric and clinimetric validity of the 20-item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg 126:1 (2002), 41–47.
24. [24] Cohen, N.A., Sinonasal mucociliary clearance in health and disease. Ann Otol Rhinol Laryngol Suppl 196 (2006), 20–26.
25. [25] Mainz, J.G., Schädlich, K., Schien, C., Michl, R., Schelhorn-Neise, P., Koitschev, A., et al. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther 10:8 (2014), 209–217.
26. [26] Silber, G., Proud, D., Warner, J., Naclerio, R., Kagey-Sobotka, A., Lichtenstein, L., et al. In vivo release of inflammatory mediators by hyperosmolar solutions. Am Rev Respir Dis 137:3 (1988), 606–612.
27. [27] van der Vaart, H., Postma, D.S., Timens, W., Kauffman, H.F., Hylkema, M.N., Ten Hacken, N.H., Repeated sputum inductions induce a transient neutrophilic and eosinophilic response. Chest 130:4 (2006), 1157–1164.
28. [28] Gräber, S.Y., Zhou-Suckow, Z., Schatterny, J., Hirtz, S., Boucher, R.C., Mall, M.A., Hypertonic saline is effective in the prevention and treatment of mucus obstruction, but not airway inflammation, in mice with chronic obstructive lung disease. Am J Respir Cell Mol Biol 49:3 (2013), 410–417.