1,557
Views
0
CrossRef citations to date
0
Altmetric
Review

Assessing effects of inhaled antibiotics in adults with non-cystic fibrosis bronchiectasis––experiences from recent clinical trials

, , &
Pages 769-782 | Received 05 Jun 2018, Accepted 19 Jul 2018, Published online: 03 Aug 2018

References

  • Pasteur MC, Bilton D, Hill AT, et al. British thoracic society guideline for non-CF bronchiectasis. Thorax. 2010;65(Suppl 1):i1–58.
  • Aliberti S, Lonni S, Dore S, et al. Clinical phenotypes in adult patients with bronchiectasis. Eur Respir J. 2016;47:1113–1122.
  • Chalmers JD, Aliberti S, Blasi F. Management of bronchiectasis in adults. Eur Respir J. 2015;45:1446–1462.
  • Munro NC, Han LY, Currie DC, et al. Radiological evidence of progression of bronchiectasis. Respir Med. 1992;86:397–401.
  • Altenburg J, Wortel K, van Der Werf TS, et al. Non-cystic fibrosis bronchiectasis: clinical presentation, diagnosis and treatment, illustrated by data from a Dutch teaching hospital. Neth J Med. 2015;73:147–154.
  • Polverino E, Goeminne PC, McDonnell MJ, et al. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017;50:1700629.
  • Sly PD, Gangell CL, Chen L, et al. Risk factors for bronchiectasis in children with cystic fibrosis. N Engl J Med. 2013;368:1963–1970.
  • Weycker D, Edelsberg J, Oster G, et al. Prevalence and economic burden of bronchiectasis. Clinical Pulmonary Medicine. 2005;12:205–209.
  • Seitz AE, Olivier KN, Adjemian J, et al. Trends in bronchiectasis among medicare beneficiaries in the United States, 2000 to 2007. Chest. 2012;142:432–439.
  • Quittner AL, Modi AC, Watrous M, et al. Cystic Fibrosis Questionnaire - revised, version 2.0. 2000 [Accessed 2017 Feb 20]. Available from: www.psy.miami.edu/cfq-Qlab.
  • Quittner AL, Marciel KK, Barker AF. Quality of Life Questionnaire - bronchiectasis, version 3.1; 2012 [cited 2017 Feb 20]. Available from: www.psy.miami.edu/cfq-Qlab.
  • Quittner AL, Marciel KK, Salathe MA, et al. A preliminary quality of life questionnaire-bronchiectasis: a patient-reported outcome measure for bronchiectasis. Chest. 2014;146:437–448.
  • Quittner AL, O’Donnell AE, Salathe MA, et al. Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores. Thorax. 2015;70:12–20.
  • Quittner AL, Sawicki GS, McMullen A, et al. Psychometric evaluation of the Cystic Fibrosis Questionnaire-Revised in a national sample. Qual Life Res. 2012;21:1267–1278.
  • Grimwood K, Bell SC, Chang AB. Antimicrobial treatment of non-cystic fibrosis bronchiectasis. Expert Rev Anti Infect Ther. 2014;12:1277–1296.
  • Weycker D, Hansen GL, Seifer FD. Prevalence and incidence of noncystic fibrosis bronchiectasis among US adults in 2013. Chron Respir Dis. 2017;14:377–384.
  • Quint JK, Millett ER, Joshi M, et al. Changes in the incidence, prevalence and mortality of bronchiectasis in the UK from 2004 to 2013: a population-based cohort study. Eur Respir J. 2016;47:186–193.
  • Joish VN, Spilsbury-Cantalupo M, Operschall E, et al. Economic burden of non-cystic fibrosis bronchiectasis in the first year after diagnosis from a US health plan perspective. Appl Health Econ Health Policy. 2013;11:299–304.
  • Blanchette CM, Noone JM, Stone G, et al. Healthcare cost and utilization before and after diagnosis of pseudomonas aeruginosa among patients with non-cystic fibrosis bronchiectasis in the U.S. Med Sci (Basel). 2017;5:E20.
  • Hodson ME, Penketh AR, Batten JC. Aerosol carbenicillin and gentamicin treatment of pseudomonas aeruginosa infection in patients with cystic fibrosis. Lancet. 1981;2:1137–1139.
  • Chalmers JD, Loebinger M, Aliberti S. Challenges in the development of new therapies for bronchiectasis. Expert Opin Pharmacother. 2015;16:833–850.
  • King PT, Holdsworth SR, Freezer NJ, et al. Characterisation of the onset and presenting clinical features of adult bronchiectasis. Respir Med. 2006;100:2183–2189.
  • Chalmers JD, Sethi S. Raising awareness of bronchiectasis in primary care: overview of diagnosis and management strategies in adults. NPJ Prim Care Respir Med. 2017;27:18.
  • Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The pulmozyme study group. N Engl J Med. 1994;331:637–642.
  • Bilton D, Canny G, Conway S, et al. Pulmonary exacerbation: towards a definition for use in clinical trials. Report from the EuroCareCF Working Group on outcome parameters in clinical trials. J Cyst Fibros. 2011;10:S79–S81.
  • Hill AT, Haworth CS, Aliberti S, et al. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017;49:1700051.
  • Goeminne P, Dupont L. Non-cystic fibrosis bronchiectasis: diagnosis and management in 21st century. Postgrad Med J. 2010;86:493–501.
  • Nicotra MB, Rivera M, Dale AM, et al. Clinical, pathophysiologic, and microbiologic characterization of bronchiectasis in an aging cohort. Chest. 1995;108:955–961.
  • Wilson CB, Jones PW, O’Leary CJ, et al. Effect of sputum bacteriology on the quality of life of patients with bronchiectasis. Eur Respir J. 1997;10:1754–1760.
  • King PT, Holdsworth SR, Freezer NJ, et al. Microbiologic follow-up study in adult bronchiectasis. Respir Med. 2007;101:1633–1638.
  • Borekci S, Halis AN, Aygun G, et al. Bacterial colonization and associated factors in patients with bronchiectasis. Ann Thorac Med. 2016;11:55–59.
  • Guan WJ, Gao YH, Xu G, et al. Effect of airway pseudomonas aeruginosa isolation and infection on steady-state bronchiectasis in Guangzhou, China. J Thorac Dis. 2015;7:625–636.
  • Angrill J, Agustí C, De Celis R, et al. Bacterial colonisation in patients with bronchiectasis: microbiological pattern and risk factors. Thorax. 2002;57:15–19.
  • Mao B, Lu HW, Li MH, et al. The existence of bronchiectasis predicts worse prognosis in patients with COPD. Sci Rep. 2015;5:10961.
  • Rogers GB, Zain NM, Bruce KD, et al. A novel microbiota stratification system predicts future exacerbations in bronchiectasis. Ann Am Thorac Soc. 2014;11:496–503.
  • McShane PJ, Naureckas ET, Tino G, et al. Non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2013;188:647–656.
  • Lee AL, Hill CJ, Cecins N, et al. The short and long term effects of exercise training in non-cystic fibrosis bronchiectasis–a randomised controlled trial. Respir Res. 2014;15:44.
  • Newall C, Stockley RA, Hill SL. Exercise training and inspiratory muscle training in patients with bronchiectasis. Thorax. 2005;60:943–948.
  • Lee AL, Burge AT, Holland AE. Positive expiratory pressure therapy versus other airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2017;9:CD011699.
  • Lee AL, Williamson HC, Lorensini S, et al. The effects of oscillating positive expiratory pressure therapy in adults with stable non-cystic fibrosis bronchiectasis: a systematic review. Chron Respir Dis. 2015;12:36–46.
  • Lee AL, Burge AT, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2015;11:CD008351.
  • Snijders D, Fernandez Dominguez B, Calgaro S, et al. Mucociliary clearance techniques for treating non-cystic fibrosis bronchiectasis: is there evidence? Int J Immunopathol Pharmacol. 2015;28:150–159.
  • Hassan JA, Saadiah S, Roslan H, et al. Bronchodilator response to inhaled beta-2 agonist and anticholinergic drugs in patients with bronchiectasis. Respirology. 1999;4:423–426.
  • O’Donnell AE, Barker AF, Ilowite JS, et al. Treatment of idiopathic bronchiectasis with aerosolized recombinant human DNase I. rhDNase Study Group. Chest. 1998;113:1329–1334.
  • Tarrant BJ, Le Maitre C, Romero L, et al. Mucoactive agents for chronic, non-cystic fibrosis lung disease: a systematic review and meta-analysis. Respirology. 2017;22:1084–1092.
  • Wilkinson M, Sugumar K, Milan SJ, et al. Mucolytics for bronchiectasis. Cochrane Database Syst Rev. 2014;5:CD001289.
  • Fan LC, Liang S, Lu HW, et al. Efficiency and safety of surgical intervention to patients with non-cystic fibrosis bronchiectasis: a meta-analysis. Sci Rep. 2015;5:17382.
  • Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356:775–789.
  • Tashkin DP, Celli B, Decramer M, et al. Bronchodilator responsiveness in patients with COPD. Eur Respir J. 2008;31:742–750.
  • Smith MP, Hill AT. Evaluating success of therapy for bronchiectasis: what end points to use? Clin Chest Med. 2012;33:329–349.
  • Chalmers JD, McDonnell MJ, Rutherford R, et al. The generalizability of bronchiectasis randomized controlled trials: a multicentre cohort study. Respir Med. 2016;112:51–58.
  • Barker AF, O’Donnell AE, Flume P, et al. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014;2:738–749.
  • Barker AF, Couch L, Fiel SB, et al. Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. Am J Respir Crit Care Med. 2000;162:481–485.
  • Bilton D, Henig N, Morrissey B, et al. Addition of inhaled tobramycin to ciprofloxacin for acute exacerbations of pseudomonas aeruginosa infection in adult bronchiectasis. Chest. 2006;130:1503–1510.
  • Serisier DJ, Bilton D, De Soyza A, et al. Inhaled, dual release liposomal ciprofloxacin in non-cystic fibrosis bronchiectasis (ORBIT-2): a randomised, double-blind, placebo-controlled trial. Thorax. 2013;68:812–817.
  • Haworth CS, Foweraker JE, Wilkinson P, et al. Inhaled colistin in patients with bronchiectasis and chronic pseudomonas aeruginosa infection. Am J Respir Crit Care Med. 2014;189:975–982.
  • Murray MP, Govan JR, Doherty CJ, et al. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011;183:491–499.
  • Drobnic ME, Suñé P, Montoro JB, et al. Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with pseudomonas aeruginosa. Ann Pharmacother. 2005;39:39–44.
  • Orriols R, Roig J, Ferrer J, et al. Inhaled antibiotic therapy in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection by pseudomonas aeruginosa. Respir Med. 1999;93:476–480.
  • Wilson R, Welte T, Polverino E, et al. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J. 2013;41:1107–1115.
  • Angrill J, Agusti C, De Celis R, et al. Bronchial inflammation and colonization in patients with clinically stable bronchiectasis. Am J Respir Crit Care Med. 2001;164:1628–1632.
  • Olivier KN, Shaw PA, Glaser TS, et al. Inhaled amikacin for treatment of refractory pulmonary nontuberculous mycobacterial disease. Ann Am Thorac Soc. 2014;11:30–35.
  • Hsieh MH, Fang YF, Chen GY, et al. The role of the high-sensitivity C-reactive protein in patients with stable non-cystic fibrosis bronchiectasis. Pulm Med. 2013;2013:795140.
  • Coban H, Gungen AC. Is there a correlation between new scoring systems and systemic inflammation in stable bronchiectasis? Can Respir J. 2017;2017:9874068.
  • Chalmers JD, Goeminne P, Aliberti S, et al. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014;189:576–585.
  • Martinez-Garcia MA, De Gracia J, Relat MV, et al. Multidimensional approach to non-cystic fibrosis bronchiectasis: the FACED score. Eur Respir J. 2014;43:1357–1367.
  • Chalmers JD, Aliberti S, Filonenko A, et al. Characterization of the “frequent exacerbator phenotype” in bronchiectasis. Am J Respir Crit Care Med. 2018;197:1410–1420.
  • Haworth C, Wanner A, Froehlich J, et al. Inhaled liposomal ciprofloxacin in patients with bronchiectasis and chronic pseudomonas aeruginosa infection: results from two parallel phase III trials (ORBIT-3 and ORBIT-4). 2nd World Bronchiectasis Conference, 2017 July 6–8; Milan, Italy.
  • Haworth CS, Wanner A, Froelich J, et al. Inhaled liposomal ciprofloxacin in patients with bronchiectasis and chronic pseudomonas aeruginosa infection: results from two parallel phase III trials (ORBIT-3 and −4) [Abstract]. Am J Respir Crit Care Med. 2017;195:A7604.
  • De Soyza A, Aksamit T, Bandel TJ, et al. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018;51:1702052.
  • Aksamit T, De Soyza A, Bandel TJ, et al. RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018;51:1702053.
  • Murray MP, Turnbull K, MacQuarrie S, et al. Validation of the Leicester Cough Questionnaire in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009;34:125–131.
  • Olveira C, Olveira G, Gaspar I, et al. Depression and anxiety symptoms in bronchiectasis: associations with health-related quality of life. Qual Life Res. 2013;22:597–605.
  • Guan WJ, Gao YH, Xu G, et al. Inflammatory responses, spirometry, and quality of life in subjects with bronchiectasis exacerbations. Respir Care. 2015;60:1180–1189.
  • Jones PW, Quirk FH, Baveystock CM, et al. A self-complete measure of health status for chronic airflow limitation. The St. George’s Respiratory Questionnaire. Am Rev Respir Dis. 1992;145:1321–1327.
  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), et al. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims; 2009 [cited 2017 Oct 27]. Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm193282.pdf.
  • European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products; 2005 [cited 2017 Oct 27]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf.
  • Spinou A, Siegert RJ, Guan WJ, et al. The development and validation of the Bronchiectasis Health Questionnaire. Eur Respir J. 2017;49:1601532.
  • Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34:648–654.
  • Guan WJ, Gao YH, Xu G, et al. Characterization of lung function impairment in adults with bronchiectasis. PLoS ONE. 2014;9:e113373.
  • McDonnell MJ, Aliberti S, Goeminne PC, et al. Multidimensional severity assessment in bronchiectasis: an analysis of seven European cohorts. Thorax. 2016;71:1110–1118.
  • Araújo D, Shteinberg M, Aliberti S, et al. The independent contribution of pseudomonas aeruginosa infection to long-term clinical outcomes in bronchiectasis. Eur Respir J. 2018;51:1701953.
  • Chotirmall SH, Chalmers JD. RESPIRE: breathing new life into bronchiectasis. Eur Respir J. 2018;51:1702444.
  • Aradigm. Aradigm reports results of FDA advisory committee meeting on Linhaliq; 2018 cited 2018 Jan 11. Available from: https://globenewswire.com/news-release/2018/01/11/1287682/0/en/Aradigm-Reports-Results-of-FDA-Advisory-Committee-Meeting-on-Linhaliq.html.
  • Aradigm. Aradigm receives complete response letter from the FDA for Linhaliq NDA; 2018 [cited 2018 Jan 29]. Available from: https://aradigm.gcs-web.com/news-releases/news-release-details/aradigm-receives-complete-response-letter-fda-linhaliq-nda.
  • Chalmers JD, Crichton M, Goeminne PC, et al. The European multicentre bronchiectasis audit and research collaboration (EMBARC): experiences from a successful ERS clinical research collaboration. Breathe (Sheff). 2017;13:180–192.
  • Chalmers JD, Aliberti S, Polverino E, et al. The EMBARC European bronchiectasis registry: protocol for an international observational study. ERJ Open Res. 2016;2:00081–2015.
  • Aksamit TR, O’Donnell AE, Barker A, et al. Adult patients with bronchiectasis: a first look at the US bronchiectasis research registry. Chest. 2017;151:982–992.
  • Olveira C, Padilla A, M-Gm Á, et al. Etiology of bronchiectasis in a cohort of 2047 patients. An analysis of the Spanish historical bronchiectasis registry. Arch Bronconeumol. 2017;53:366–374.
  • Chalmers JD, Chotirmall SH. Bronchiectasis: new therapies and new perspectives. Lancet Respir Med. 2018. S2213-600(18)30053–5.
  • Chen CL, Huang Y, Gao YH, et al. Inhaled medication therapy for bronchiectasis: status quo and the next frontier. Expert Opin Investig Drugs. 2018;27:211–218.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.