Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.

Summary

To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD. Secondary Aims: To determine the: 1. Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics. 2. Efficacy of nebulized 5% hypertonic saline on lung function 3. Adverse effects of nebulized 5% hypertonic saline in children

Timeline

Start

2021-02-04

Primary completion

2023-08-28

Completion

2023-08-28

Publications

• Results McCallum GB, Binks MJ. The Epidemiology of Chronic Suppurative Lung Disease and Bronchiectasis in Children and Adolescents. Front Pediatr. 2017 Feb 20;5:27. doi: 10.3389/fped.2017.00027. eCollection 2017.
• Results Lovie-Toon YG, Grimwood K, Byrnes CA, Goyal V, Busch G, Masters IB, Marchant JM, Buntain H, O'Grady KF, Chang AB. Health-resource use and quality of life in children with bronchiectasis: a multi-center pilot cohort study. BMC Health Serv Res. 2019 Aug 13;19(1):561. doi: 10.1186/s12913-019-4414-5.
• Results Chang AB, Bush A, Grimwood K. Bronchiectasis in children: diagnosis and treatment. Lancet. 2018 Sep 8;392(10150):866-879. doi: 10.1016/S0140-6736(18)31554-X.
• Results Nathan AM, Muthusamy A, Thavagnanam S, Hashim A, de Bruyne J. Chronic suppurative lung disease in a developing country: impact on child and parent. Pediatr Pulmonol. 2014 May;49(5):435-40. doi: 10.1002/ppul.23001. Epub 2014 Jan 31.
• Results Kumar A, Lodha R, Kumar P, Kabra SK. Non-cystic fibrosis bronchiectasis in children: clinical profile, etiology and outcome. Indian Pediatr. 2015 Jan;52(1):35-7. doi: 10.1007/s13312-015-0563-8.
• Results Kapur N, Masters IB, Newcombe P, Chang AB. The burden of disease in pediatric non-cystic fibrosis bronchiectasis. Chest. 2012 Apr;141(4):1018-1024. doi: 10.1378/chest.11-0679. Epub 2011 Sep 1.
• Results Gaillard EA, Carty H, Heaf D, Smyth RL. Reversible bronchial dilatation in children: comparison of serial high-resolution computer tomography scans of the lungs. Eur J Radiol. 2003 Sep;47(3):215-20. doi: 10.1016/s0720-048x(02)00122-5.
• Results Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.
• Results Hahn A, Warnken S, Perez-Losada M, Freishtat RJ, Crandall KA. Microbial diversity within the airway microbiome in chronic pediatric lung diseases. Infect Genet Evol. 2018 Sep;63:316-325. doi: 10.1016/j.meegid.2017.12.006. Epub 2017 Dec 7.
• Results Zemanick ET, Harris JK, Wagner BD, Robertson CE, Sagel SD, Stevens MJ, Accurso FJ, Laguna TA. Inflammation and airway microbiota during cystic fibrosis pulmonary exacerbations. PLoS One. 2013 Apr 30;8(4):e62917. doi: 10.1371/journal.pone.0062917. Print 2013.
• Results Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.
• Results Prentice BJ, Wales S, Doumit M, Owens L, Widger J. Children with bronchiectasis have poorer lung function than those with cystic fibrosis and do not receive the same standard of care. Pediatr Pulmonol. 2019 Dec;54(12):1921-1926. doi: 10.1002/ppul.24491. Epub 2019 Sep 1.
• Results Chang AB. Bronchiectasis: so much yet to learn and to do. Paediatr Respir Rev. 2011 Jun;12(2):89-90. doi: 10.1016/j.prrv.2011.01.001. Epub 2011 Feb 2. No abstract available.
• Results Tarran R, Grubb BR, Parsons D, Picher M, Hirsh AJ, Davis CW, Boucher RC. The CF salt controversy: in vivo observations and therapeutic approaches. Mol Cell. 2001 Jul;8(1):149-58. doi: 10.1016/s1097-2765(01)00286-6.
• Results Kerem E, Reisman J, Corey M, Canny GJ, Levison H. Prediction of mortality in patients with cystic fibrosis. N Engl J Med. 1992 Apr 30;326(18):1187-91. doi: 10.1056/NEJM199204303261804.
• Results Reeves EP, Williamson M, O'Neill SJ, Greally P, McElvaney NG. Nebulized hypertonic saline decreases IL-8 in sputum of patients with cystic fibrosis. Am J Respir Crit Care Med. 2011 Jun 1;183(11):1517-23. doi: 10.1164/rccm.201101-0072OC. Epub 2011 Feb 17.
• Results Elkins MR, Bye PT. Inhaled hypertonic saline as a therapy for cystic fibrosis. Curr Opin Pulm Med. 2006 Nov;12(6):445-52. doi: 10.1097/01.mcp.0000245714.89632.b2.
• Results Dellon EP, Donaldson SH, Johnson R, Davis SD. Safety and tolerability of inhaled hypertonic saline in young children with cystic fibrosis. Pediatr Pulmonol. 2008 Nov;43(11):1100-1106. doi: 10.1002/ppul.20909.
• Results Kellett F, Redfern J, Niven RM. Evaluation of nebulised hypertonic saline (7%) as an adjunct to physiotherapy in patients with stable bronchiectasis. Respir Med. 2005 Jan;99(1):27-31. doi: 10.1016/j.rmed.2004.05.006.
• Results Kellett F, Robert NM. Nebulised 7% hypertonic saline improves lung function and quality of life in bronchiectasis. Respir Med. 2011 Dec;105(12):1831-5. doi: 10.1016/j.rmed.2011.07.019. Epub 2011 Oct 22.
• Results Nicolson CH, Stirling RG, Borg BM, Button BM, Wilson JW, Holland AE. The long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis. Respir Med. 2012 May;106(5):661-7. doi: 10.1016/j.rmed.2011.12.021. Epub 2012 Feb 19.
• Results Paff T, Daniels JM, Weersink EJ, Lutter R, Vonk Noordegraaf A, Haarman EG. A randomised controlled trial on the effect of inhaled hypertonic saline on quality of life in primary ciliary dyskinesia. Eur Respir J. 2017 Feb 23;49(2):1601770. doi: 10.1183/13993003.01770-2016. Print 2017 Feb.
• Results Sidhu MK, Mandal P, Hill AT. Developing drug therapies in bronchiectasis. Expert Opin Investig Drugs. 2015 Feb;24(2):169-81. doi: 10.1517/13543784.2015.971153. Epub 2014 Oct 11.
• Results Goyal V, Grimwood K, Marchant J, Masters IB, Chang AB. Does failed chronic wet cough response to antibiotics predict bronchiectasis? Arch Dis Child. 2014 Jun;99(6):522-5. doi: 10.1136/archdischild-2013-304793. Epub 2014 Feb 12.
• Results Chang AB, Boyce NC, Masters IB, Torzillo PJ, Masel JP. Bronchoscopic findings in children with non-cystic fibrosis chronic suppurative lung disease. Thorax. 2002 Nov;57(11):935-8. doi: 10.1136/thorax.57.11.935.
• Results Kapur N, Masel JP, Watson D, Masters IB, Chang AB. Bronchoarterial ratio on high-resolution CT scan of the chest in children without pulmonary pathology: need to redefine bronchial dilatation. Chest. 2011 Jun;139(6):1445-1450. doi: 10.1378/chest.10-1763. Epub 2010 Sep 23.
• Results Newcombe PA, Sheffield JK, Petsky HL, Marchant JM, Willis C, Chang AB. A child chronic cough-specific quality of life measure: development and validation. Thorax. 2016 Aug;71(8):695-700. doi: 10.1136/thoraxjnl-2015-207473. Epub 2016 Feb 3.
• Results Callahan BJ, McMurdie PJ, Rosen MJ, Han AW, Johnson AJ, Holmes SP. DADA2: High-resolution sample inference from Illumina amplicon data. Nat Methods. 2016 Jul;13(7):581-3. doi: 10.1038/nmeth.3869. Epub 2016 May 23.
• Results McMurdie PJ, Holmes S. phyloseq: an R package for reproducible interactive analysis and graphics of microbiome census data. PLoS One. 2013 Apr 22;8(4):e61217. doi: 10.1371/journal.pone.0061217. Print 2013.
• Results Love MI, Huber W, Anders S. Moderated estimation of fold change and dispersion for RNA-seq data with DESeq2. Genome Biol. 2014;15(12):550. doi: 10.1186/s13059-014-0550-8.
• Results Chang AB, Fong SM, Yeo TW, Ware RS, McCallum GB, Nathan AM, Ooi MH, de Bruyne J, Byrnes CA, Lee B, Nachiappan N, Saari N, Torzillo P, Smith-Vaughan H, Morris PS, Upham JW, Grimwood K. HOspitalised Pneumonia Extended (HOPE) Study to reduce the long-term effects of childhood pneumonia: protocol for a multicentre, double-blind, parallel, superiority randomised controlled trial. BMJ Open. 2019 Apr 24;9(4):e026411. doi: 10.1136/bmjopen-2018-026411.
• Results Kapur N, Masters IB, Morris PS, Galligan J, Ware R, Chang AB. Defining pulmonary exacerbation in children with non-cystic fibrosis bronchiectasis. Pediatr Pulmonol. 2012 Jan;47(1):68-75. doi: 10.1002/ppul.21518. Epub 2011 Aug 9.
• Results Stanojevic S, Wade A, Stocks J, Hankinson J, Coates AL, Pan H, Rosenthal M, Corey M, Lebecque P, Cole TJ. Reference ranges for spirometry across all ages: a new approach. Am J Respir Crit Care Med. 2008 Feb 1;177(3):253-60. doi: 10.1164/rccm.200708-1248OC. Epub 2007 Nov 15.
• Results Walker PP, Key AL. How to perform peak flow and spirometry tests. BMJ. 2016 May 11;353:h6159. doi: 10.1136/sbmj.h6159. No abstract available.
• Results Newcombe PA, Sheffield JK, Chang AB. Parent cough-specific quality of life: development and validation of a short form. J Allergy Clin Immunol. 2013 Apr;131(4):1069-74. doi: 10.1016/j.jaci.2012.10.004. Epub 2012 Nov 10.

Drugs

Indications