Scolaris Content Display Scolaris Content Display

停止使用长效β2受体激动剂(LABA)治疗哮喘通过LABA加吸入皮质类固醇治疗得到良好控制的儿童

Contraer todo Desplegar todo

Referencias

References to studies excluded from this review

Aalbers 2005 {published data only}

Aalbers R, Harris A, Naya I. Adjustable dosing with budesonide/formoterol achieves sustained guideline 'well‐controlled asthma' following step down in treatment [Abstract]. European Respiratory Journal 2005;26:A431. CENTRAL

Berger 2010 {published and unpublished data}

AstraZeneca. A 12‐week randomized, double‐blind, double‐dummy, placebo‐ and active‐controlled study of Symbicort pMDI administered once daily in adults and adolescents with asthma. http://www.astrazenecaclinicaltrials.com/ (accessed 10 September 2014). [AstraZeneca: SD‐039‐0726]CENTRAL
Berger WE, Bleecker ER, O'Dowd L, Miller CJ, Mezzanotte W. Efficacy and safety of budesonide/formoterol pressurized metered‐dose inhaler: randomized controlled trial comparing once‐ and twice‐daily dosing in patients with asthma. Allergy and Asthma Proceedings 2010;31(1):49‐59. CENTRAL

Bumbacea 2010 {published data only}

Bumbacea D, Dymek A, Mansikka H. P16 Fluticasone propionate/formoterol fumarate combination therapy has an efficacy and safety profile similar to that of its individual components administered concurrently: A randomised controlled trial [Abstract]. Thorax 2010;65((Suppl 4)):A83. CENTRAL

Cowie 2007 {published data only}

Cowie RL, Boulet LP, Keith PK, Scott‐Wilson CA, House KW, Dorinsky PM. Tolerability of a salmeterol xinafoate/fluticasone propionate hydrofluoroalkane metered‐dose inhaler in adolescent and adult patients with persistent asthma: a 52‐week, open‐label, stratified, parallel‐group, multicenter study. Clinical Therapeutics 2007;29(7):1390‐402. CENTRAL

FitzGerald 2003 {published data only}

FitzGerald JM, Sears MR, Boulet LP, Becker AB. Erratum: Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five month multicentre Canadian study [Canadian Respiratory Journal (2003) vol. 10 (8) (427‐434)]. Canadian Respiratory Journal [Revue canadienne de pneumologie] 2004;11(1):20. CENTRAL
FitzGerald JM, Sears MR, Boulet LP, Becker AB, McIvor AR, Ernst P, et al. Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five‐month multicentre Canadian study. Canadian Respiratory Journal [Revue canadienne de pneumologie] 2003;10(8):427‐34. CENTRAL

Fowler 2002 {published data only}

Fowler SJ, Currie GP, Lipworth BJ, Currie PC. Step‐down therapy with low‐dose fluticasone‐salmeterol combination or medium‐dose hydrofluoroalkane 134a‐beclomethasone alone. Journal of Allergy and Clinical Immunology 2002;109(6):929‐35. CENTRAL

Godard 2008 {published and unpublished data}

GlaxoSmithKline. Maintenance of asthma control in adults: comparison of three therapeutic strategies in patients whose asthma is controlled by a medium dose of inhaled corticosteroid and a long‐acting inhaled 2‐agonist. http://www.gsk‐clinicalstudyregister.com/ (accessed 10 September 2014). CENTRAL
Godard P, Attali V. Comparison of different treatment strategies in stepping down combination treatment withdrawing the LABA versus reducing the ICS dose [Abstract]. Proceedings of the American Thoracic Society 2006;3(3):A213. CENTRAL
Godard P, Greillier P, Pigearias B, Nachbaur G, Desfougeres J‐L, Attali V. Maintaining asthma control in persistent asthma: comparison of three strategies in a 6‐month double‐blind randomised study. Respiratory Medicine 2008;102(8):1124‐31. CENTRAL

GSK ADA109315 {unpublished data only}

GSK ADA109315. A retrospective study of healthcare utilization and costs of step‐down therapy in asthma patients receiving fluticasone propionate/salmeterol combination. www.gsk‐clinicalstudyregister.com/files2/26012.pdf (accessed 9 December 2014). CENTRAL

GSK SAS40037 {unpublished data only}

GlaxoSmithKline. Randomized, double‐blind, double‐dummy, parallel group, 16‐week comparison of asthma control in adolescents and adults receiving either fluticasone propionate/salmeterol Diskus combination product 100/50 mcg BID, fluticasone propionate Diskus 100 mcg BID, salmeterol xinafoate Diskus 50 mcg BID, or oral montelukast 10 mg Q. www.gsk‐clinicalstudyregister.com/ (accessed 10 September 2014). CENTRAL
Oppenheimer J, Stauffer J, Waitkus‐Edwards K, Yancey S, Prillaman B, Sutton L, et al. “Stepping down” from fluticasone propionate/salmeterol 100/50mcg Diskus results in loss of asthma control. American Thoracic Society 100th International Conference; 2004 May 21‐26; Orlando. 2004:J94. CENTRAL

GSK SMS30046 {unpublished data only}

GSK SMS30046. Effects of long‐term administration of salmeterol on clinical symptoms, inhaled corticosteroid requirement and bronchial reactivity, and the effect of stopping long‐term salmeterol treatment. www.gsk‐clinicalstudyregister.com/study/SMS30046#rs (accessed 8 December 2014). CENTRAL
Wilding P, Clark M, Thompson Coon J, Lewis S, Rushton L, Bennett J, et al. Effect of long‐term treatment with salmeterol on asthma control: a double blind, randomised crossover study. BMJ 1997;314(7092):1441‐6. CENTRAL

Harrison 1997 {published data only}

Harrison TW, Oborne J, Wilding PJ, Tattersfield AE. A controlled trial of beta2‐agonist dose reduction in asthmatic patients on high doses of beta2‐agonist [Abstract]. European Respiratory Journal 1997;10(Suppl 25):3S. CENTRAL

Ind 2004 {published data only}

Ind PW, Haughney J, Price D, Rosen JP, Kennelly J. Adjustable and fixed dosing with budesonide/formoterol via a single inhaler in asthma patients: the ASSURE study. Respiratory Medicine 2004;98(5):464‐75. CENTRAL

Koenig 2008 {published and unpublished data}

Dorinsky P, Stauffer J, Waitkus‐Edwards K, Yancey S, Prillaman B, Sutton L. Stepping down from fluticasone propionate/salmeterol 100/50mcg Diskus results in loss of asthma control [Abstract]. European Respiratory Journal 2004;24((suppl 48)):309s. CENTRAL
Dorinsky PM, Stauffer J, Waitkus‐Edwards K, Yancey S, Prillaman BA, Sutton L. "Stepping down" from fluticasone propionate/salmeterol 100/50mcg Diskus(R) results in loss of asthma control: lack of effect of ethnic origin [Abstract]. Chest 2004;126((4 Suppl)):758S‐a. CENTRAL
GlaxoSmithKline. A multicenter, randomized, double‐blind, double‐dummy, parallel group, 16‐week comparison of asthma control in adolescents and adults receiving either fluticasone propionate/salmeterol Diskus combination product 100/50 mcg BID, fluticasone propionate Diskus 100 mcg BID, salmeterol xinafoate Diskus 50 mcg BID, or oral montelukast 10mg QD. www.gsk‐clinicalstudyregister.com/ (accessed 10 September 2014). CENTRAL
Koenig S, Waitkus‐Edwards K, Yancey S, Prillaman B, Dorinsky P. Loss of asthma control when patients receiving fluticasone propionate/salmeterol 100/50μg Diskus are “stepped down” to fluticasone propionate, salmeterol or montelukast alone. Journal of Allergy and Clinical Immunology 2004;113(2):S94. CENTRAL
Koenig SM, Ostrom N, Pearlman D, Waitkus‐Edwards K, Yancey S, Prillaman BA, et al. Deterioration in asthma control when subjects receiving fluticasone propionate/salmeterol 100/50 mcg Diskus are 'stepped‐down'. Journal of Asthma 2008;45(8):681‐7. CENTRAL

Liu 2007 {published data only}

Liu CT, Wang YM, Wang G, Tan CW, Pang YM. A clinical study on the significance of airway hyperresponsiveness monitoring in the adjustment of combined therapy for asthmatic patients. Zhonghua jie he he hu xi za zhi [Chinese Journal of Tuberculosis and Respiratory Diseases] 2007;30(7):498‐503. CENTRAL

Nathan 2009 {published data only}

Nathan R, Pearlman D, Nayak A, Nolte H. Safety and tolerability of medium‐dose mometasone furoate/formoterol treatment versus mometasone furoate or formoterol monotherapies in persistent asthmatics who previously used medium‐dose inhaled corticosteroids (alone or with long‐acting beta2‐agonist) [Abstract]. Chest 2009;136(4):8S. CENTRAL
Nathan R, Pearlman D, Nolte H, Nayak A. Safety and tolerability of mometasone furoate/formoterol for persistent asthma subjects who previously were treated with medium‐dose inhaled corticosteroids (alone or with a long‐acting beta2‐agonist) [Abstract]. Annals of Allergy, Asthma & Immunology 2009;103(4):A58. CENTRAL

NCT00158834 {unpublished data only}

NCT00158834. Pediatric asthma study using stepwise treatment with two Food and Drug Administration approved asthma medications. www.clinicaltrials.gov/ct2/show/study/NCT00158834 (accessed 5 December 2014). CENTRAL

NCT01565031 {unpublished data only}

NCT01565031. Prediction of future risk in patients with controlled asthma. https://clinicaltrials.gov/show/NCT01565031 (accessed 9 December 2014). CENTRAL

NCT02094937 {unpublished data only}

NCT02094937. A study to compare the efficacy and safety of fluticasone furoate (FF) 100 mcg once daily with fluticasone propionate (FP) 250 mcg twice daily (BD) and FP 100 mcg BD in well‐controlled asthmatic Japanese subjects. https://clinicaltrials.gov/ct2/show/NCT02094937 (accessed 9 September 2014). CENTRAL

NTR2045 {unpublished data only}

Kersten E. The effect of stepping down asthma therapy in clinically stable children on exercise induced asthma. www.trialregister.nl/trialreg/admin/rctview.asp?TC=2045 (accessed 5 December 2014). CENTRAL

Obase 2013 {published data only}

Obase Y, Ikeda M, Kurose K, Abe M, Shimizu H, Ohue Y, et al. Step‐down of budesonide/formoterol in early stages of asthma treatment leads to insufficient anti‐inflammatory effect. Journal of Asthma 2013;50(7):718‐21. CENTRAL

Paggiaro 2011 {published data only}

Paggiaro P, Nicolini G, Crimi N, Fabbri L, Olivieri D, Rossi A, et al. Six months step down treatment from high dose ICS/LABA combination therapy in asthma [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A1278. CENTRAL
Paggiaro P, Nicolini G, Crimi N, Fabbri LM, Olivieri D, Rossi A, et al. Asthma control and lung function after step down from high dose ICS/LABA combination therapy [Abstract]. European Respiratory Journal 2011;38(suppl 55):722s [P3967]. CENTRAL

Papi 2012 {published data only}

NCT00497237. Prospective, randomised, open‐label, multicentre, active drug controlled, parallel group design clinical trial of the efficacy and safety of beclomethasone dipropionate 400 Mcg + formoterol 24 mcg pMDI via HFA‐134a (Foster™) vs. fluticasone propionate 500 mcg + salmeterol xinafoate 100 mcg DPI (Seretide Diskus®) in the 6 months stepdown treatment of adult patients with controlled asthma. https://clinicaltrials.gov/show/NCT00497237 (accessed 9 December 2014). CENTRAL
Papi A, Nicolini G, Crimi N, Fabbri L, Olivieri D, Rossi A, et al. Step‐down from high dose fixed combination therapy in asthma patients: a randomized controlled trial. Respiratory Research 2012;13:54. CENTRAL

Reddel 2010 {published and unpublished data}

GlaxoSmithKline. A 13‐month, randomised, double‐blind, parallel‐group comparison of the efficacy of Seretide (fluticasone propionate/salmeterol combination Accuhaler) and Flixotide (fluticasone propionate Accuhaler) when down‐titrating the inhaled corticosteroid dose in asthmatic adults who have previously received Seretide 500/50 mcg twice daily for at least 4wk. www.gsk‐clinicalstudyregister.com/ (accessed 10 September 2014). CENTRAL
Reddel HK, Gibson PG, Peters MJ, Wark PAB, Sand IB, Hoyos CM, et al. Down‐titration from high‐dose combination therapy in asthma: Removal of long‐acting beta(2)‐agonist. Respiratory Medicine 2010;104(8):1110‐20. CENTRAL
Reddel HK, Peyters MJ, Wark PA, Sand IB, Jenkins CR. Comparison of the efficacy of Seretide and Flixotide when down‐titrating the inhaled corticosteroid dose. Thoracic Society of Australia and New Zealand Annual Scientific Meeting; 2007 Mar 25‐28; Auckland. 2007:TP041. CENTRAL

Self 1998 {published data only}

Rumbak M, Self T, Kelso T, Eberle L, Abou‐Shala N, Learned S, et al. Moderate to high dose inhaled corticosteroids in adult asthmatics: does salmeterol facilitate step down therapy? [Abstract]. European Respiratory Journal 1998;12((Suppl 29)):19s. CENTRAL
Self T, Rumbak MJ, Kelso T, Eberle L, Abou Shala N, Learned CC, et al. Does salmeterol facilitate 'step‐down' therapy in patients with asthma receiving moderate to high doses of inhaled corticosteroids?. Current Therapeutic Research, Clinical and Experimental 1998;59(11):803‐11. CENTRAL

Shamsul 2007 {published data only}

Shamsul AI, Hadzri HM, Noradina AT, Fauzi MA, Hamid AJ, Rosalina AM, et al. Step‐down approach in chronic stable asthma; a comparison of reducing dose inhaled formoterol/budesonide with maintaining inhaled budesonide [Abstract]. Respirology 2007;12(s4):A141. CENTRAL

Slankard 2011 {published and unpublished data}

Slankard ML, Canfield S, Michelis M, Mansukhani M, McGoey B, Paige A, et al. ADRB2 (adrenergic B2 receptor agonist gene) Arg 16 allele and effect of LABA withdrawal in patients with moderate to severe asthma [Abstract]. Journal of Asthma and Clinical Immunology (Proceedings of the AAAAI Annual Meeting 2011) 2011;127(2):AB67. CENTRAL

Zangrilli 2009 {published data only}

Zangrilli J, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol (BUD/FM) vs BUD in Hispanic patients: Differential results when including run‐in lung function vs controller history and run‐in symptoms [Abstract]. Annals of Allergy, Asthma and Immunology 2009;103:5. CENTRAL

References to ongoing studies

NCT01437995 {unpublished data only}

NCT01437995. Long‐acting beta agonist step down study (LASST). Available from http://clinicaltrials.gov/show/NCT01437995 (accessed 10 September 2014). CENTRAL

Additional references

Adams 2005

Adams NP, Bestall JB, Malouf R, Lasserson TJ, Jones PW. Beclomethasone versus placebo for chronic asthma. Cochrane Database of Systematic Reviews 2005, Issue 1. [DOI: 10.1002/14651858.CD002738.pub2]

Adams 2009

Adams NP, Bestall JC, Lasserson TJ, Jones P, Cates CJ. Fluticasone versus placebo for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD003135.pub4]

Ahmad 2014

Ahmad S, Kew KM, Normansell R. Stopping long‐acting beta2‐agonists (LABA) for adults with asthma well‐controlled on LABA and inhaled corticosteroids. Cochrane Database of Systematic Reviews 2014, Issue 9. [DOI: 10.1002/14651858.CD011306]

Anderson 2005

Anderson HR. Prevalence of asthma. BMJ 2005;330:1037.

Australian Asthma Handbook 2014

National Asthma Council Australia. Australian Asthma Handbook 2014, Version 1.0. www.asthmahandbook.org.au (accessed 28 July 2014). [ISSN: 2203–4722]

Barnes 1993

Barnes PJ, Adcock I. Anti‐inflammatory actions of steroids: molecular mechanisms. Trends in Pharmacological Sciences 1993;14:436‐41.

Bijl‐Hofland 2001

Bijl‐Hofland ID, Cloosterman SG, Folgering HT, van den Elshout FJ, van Weel C, van Schayck CP. Inhaled corticosteroids, combined with long‐acting beta2‐agonists, improve the perception of bronchoconstriction in asthma. American Journal of Respiratory and Critical Care Medicine 2001;164(5):764‐9.

Brown 1983

Brown MJ, Brown DC, Murphy MB. Hypokalemia from beta2‐receptor stimulation by circulating epinephrine. The New England Journal of Medicine 1983;309(23):1414‐9.

Brozek 2012

Brozek JL, Kraft M, Krishnan JA, Cloutier MM, Lazarus SC, Li JT, et al. Long‐acting ß2‐agonist step‐off in patients with controlled asthma. Archives of Internal Medicine 2012;172(18):1365‐75.

BTS 2011

British Thoracic Society. Adult asthma audit report 2011. www.brit‐thoracic.org.uk/audit‐and‐quality‐improvement/ (accessed 9 June 2014).

BTS/SIGN 2012

British Thoracic Society/Scottish Intercollegiate Guidelines Network (BTS/SIGN). British Guideline on the Management of Asthma. http://www.brit‐thoracic.org.uk/guidelines/asthma‐guidelines.aspx (accessed 6 June 2014).

Bush 2009

Bush A, Menzies‐Gow A. Phenotypic differences between pediatric and adult asthma. Proceedings of the American Thoracic Society 2009;6(8):712‐9.

Cates 2012a

Cates CJ, Cates MJ. Regular treatment with formoterol for chronic asthma: serious adverse events. Cochrane Database of Systematic Reviews 2012, Issue 4. [DOI: 10.1002/14651858.CD006923.pub3]

Cates 2012b

Cates CJ, Oleszczuk M, Stovold E, Wieland LS. Safety of regular formoterol or salmeterol in children with asthma: an overview of Cochrane reviews. Cochrane Database of Systematic Reviews 2012, Issue 10. [DOI: 10.1002/14651858.CD010005.pub2]

Cates 2014

Cates CJ, Wieland LS, Oleszczuk M, Kew KM. Safety of regular formoterol or salmeterol in adults with asthma: an overview of Cochrane reviews. Cochrane Database of Systematic Reviews 2014, Issue 2. [DOI: 10.1002/14651858.CD010314.pub2]

Crane 1989

Crane J, Pearce N, Flatt A, Burgess C, Jackson R, Kwong T, et al. Prescribed fenoterol and death from asthma in New Zealand. The Lancet 1989;1(8644):917‐22.

Ducharme 2008

Ducharme FM, Ni Chroinin M, Greenstone I, Lasserson TJ. Addition of long‐acting beta2‐agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2008, Issue 5. [DOI: 10.1002/14651858.CD005535.pub2]

Ducharme 2010

Ducharme FM, Ni Chroinin M, Greenstone I, Lasserson TJ. Addition of long‐acting beta2‐agonists to inhaled steroids versus higher dose inhaled steroids in adults and children with persistent asthma. Cochrane Database of Systematic Reviews 2010, Issue 4. [DOI: 10.1002/14651858.CD005533.pub2]

Ernst 2006

Ernst P, McIvor A, Ducharme FM, Boulet LP, Fitzgerald M, Chapman KR, et al. Safety and effectiveness of long‐acting inhaled beta‐agonist bronchodilators when taken with inhaled corticosteroids. Annals of Internal Medicine 2006;146(9):692‐4.

FDA 2010

United States Food, Drug Administration. FDA News Release: FDA Announces New Safety Controls for Long‐Acting Beta Agonists, Medications Used to Treat Asthma. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm200931.htm (accessed 6 May 2015).

GINA 2009

Global Initiative for Asthma. Global Strategy for the Diagnosis and Management of Asthma in Children 5 Years and Younger. http://www.ginasthma.org/Global‐Strategy‐for‐the‐Diagnosis‐and‐Management‐of‐Asthma‐in‐Children‐5‐Years‐and‐Younger (accessed 28 July 2014).

GINA 2014

Global Initiative for Asthma (GINA). From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014. http://www.ginasthma.org/local/uploads/files/GINA_Report_2014_Jun11.pdf (accessed 19 June 2014).

Global Asthma Report 2011

International Union Against Tuberculosis and Lung Disease. The Global Asthma Report 2011. Available from http://www.theunion.org/what‐we‐do/publications/technical/global‐asthma‐report (accessed 4 Aug 2014).

Hernández 2014

Hernández G, Avila M, Pont A, Garin O, Alonso J, Laforest L, et al. Long‐acting beta‐agonists plus inhaled corticosteroids safety: a systematic review and meta‐analysis of non‐randomized studies. Respiratory Research 2014;15:83.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1 [updated March 2011]. The Cochrane Collaboration. www.cochrane‐handbook.org.

Johnston 2009

Johnston SL, Edwards MR. Mechanisms of adverse effects of beta‐agonists in asthma. Thorax 2009;64(9):739‐41.

Lemanske 2011

Lemanske RF, Mauger DT, Sorkness CA, Jackson DJ, Boehmer SJ, Martinez FD, et al. Step‐up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. The New England Journal of Medicine 2010;362:975‐85.

Lipworth 1997

Lipworth BJ. Airway subsensitivity with long‐acting beta2‐agonists: is there a cause for concern?. Drug Safety 1997;16(5):295‐30.

McMahon 2011

McMahon AW, Levenson MS, McEvoy BW, Mosholder AD. Age and risks of FDA‐approved long‐acting β₂‐adrenergic receptor agonists. Pediatrics 2011;128(5):e1147‐54.

NAEPP 2007

National Asthma Education and Prevention Program. Guidelines for the Diagnosis and Management of Asthma. www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf (accessed 6 June 2014).

NCT01462344

NCT01462344. 6‐month Safety and Benefit Study of ADVAIR in Children 4‐11 Years Old (VESTRI). https://www.clinicaltrials.gov/ct2/show/NCT01462344 (accessed 29 June 2012).

Nelson 1995

Nelson HS. Beta‐adrenergic bronchodilators. The New England Journal of Medicine 1995;333(8):449‐506.

Nelson 2006

Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, SMART Study Group. The salmeterol multicenter asthma research trial. Chest 2006;129:15‐26.

Ni Chroinin 2009

Ni Chroinin M, Lasserson TJ, Greenstone I, Ducharme FM. Addition of long‐acting beta‐agonists to inhaled corticosteroids for chronic asthma in children. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD007949]

NRAD 2014

Royal College of Physicians. Why asthma still kills: the national review of asthma deaths. https://www.rcplondon.ac.uk/sites/default/files/why‐asthma‐still‐kills‐full‐report.pdf (accessed 28 August 2014).

Oppenheimer 2008

Oppenheimer J, Nelson HS. Safety of long‐acting β‐agonists in asthma: a review. Current Opinion in Pulmonary Medicine 2008;14:64‐9.

PHAC 2007

Public Health Agency of Canada. Life and Breath: Respiratory Disease in Canada. http://www.phac‐aspc.gc.ca/ (accessed 28 July 2014).

Pruteanu 2014

Pruteanu AI, Chauhan BF, Zhang L, Prietsch SOM, Ducharme FM. Inhaled corticosteroids in children with persistent asthma: dose‐response effects on growth. Cochrane Database of Systematic Reviews 2014, Issue 7. [DOI: 10.1002/14651858.CD009878.pub2]

Review Manager 2014 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Salpeter 2006

Salpeter SR, Buckley NS, Ormiston TM, Salpeter EE. Meta‐analysis: effect of long‐acting beta‐agonists on severe asthma exacerbations and asthma related deaths. Annals of Internal Medicine 2006;144:904‐12.

Spycher 2010

Spycher BD, Silverman M, Kuehni CE. Phenotypes of childhood asthma: are they real?. Experimental Allergy 2010;40:1130‐41.

Tattersfield 2006

Tattersfield AE. Current issues with beta2‐adrenoceptor agonists: historical background. Clinical Reviews in Allergy and Immunology 2006;31(2‐3):107‐18.

Zhang 2011

Zhang L, Axelsson I, Chung M, Lau J. Dose response of inhaled corticosteroids in children with persistent asthma: a systematic review. Pediatrics 2011;127(1):129‐38.

Zhang 2014

Zhang L, Prietsch SOM, Ducharme FM. Inhaled corticosteroids in children with persistent asthma: effects on growth. Cochrane Database of Systematic Reviews 2014, Issue 7. [DOI: 10.1002/14651858.CD009471.pub2]

Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Aalbers 2005

Wrong comparison ‐ not stepping down LABA

Berger 2010

Wrong population ‐ adults

Bumbacea 2010

Wrong comparison ‐ not stopping LABA

Cowie 2007

Wrong comparison ‐ not stopping LABA

FitzGerald 2003

Wrong comparison ‐ not stopping LABA

Fowler 2002

Wrong comparison ‐ ICS dose was higher in the step‐down group

Godard 2008

Wrong population ‐ adults

GSK ADA109315

Wrong comparison ‐ not stopping LABA

Analysis of healthcare utilisation and costs of stepping down LABA

GSK SAS40037

Wrong population ‐ adults

GSK SMS30046

Wrong study design ‐ cross‐over study

Harrison 1997

Wrong comparison ‐ not stopping LABA

Ind 2004

Wrong comparison ‐ not stopping LABA

Koenig 2008

Wrong population ‐ adults

Liu 2007

Wrong population ‐ adults

Nathan 2009

Wrong comparison ‐ not stopping LABA

NCT00158834

Wrong comparison ‐ not stopping LABA using symptom scores with or without PD20 methacholine to adjust treatment

NCT01565031

Wrong comparison ‐ no clear step‐down strategy for LABA

NCT02094937

Wrong population ‐ adults (ongoing trial)

NTR2045

Wrong study design ‐ single‐group observational study

The effect of stepping down from LABA/ICS combination therapy to ICS monotherapy on exercise and mannitol challenge tests in asthmatic children

Obase 2013

Wrong comparison ‐ not stopping LABA

Paggiaro 2011

Wrong comparison ‐ not stopping LABA

Papi 2012

Wrong comparison ‐ not stopping LABA

Reddel 2010

Wrong population ‐ adults

Self 1998

Wrong comparison ‐ ICS stepped down

Shamsul 2007

Wrong comparison ‐ two step‐down groups

Slankard 2011

Wrong population ‐ adults

Zangrilli 2009

Wrong comparison ‐ ICS stepped down

Characteristics of ongoing studies [ordered by study ID]

NCT01437995

Trial name or title

Long‐acting Beta Agonist Step Down Study (LASST)

Methods

56‐week, multicentre, blinded, randomised, double‐masked parallel group comparative effectiveness study of approaches to stepping down therapy for people with well‐controlled asthma treated with combination ICS and LABA.

Participants

Inclusion Criteria: males and females aged 12‐80 years with well‐controlled asthma on moderate dose ICS/LABA based on an Asthma Control Test score ≥ 20, absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrolment and a pre‐bronchodilator FEV1 ≥ 70% predicted

Exclusion Criteria: chronic oral steroid therapy, hospitalisation or urgent care visit within 4 weeks of the screening visit, lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other lung disease. Less than 10 pack/yr of tobacco use and abstinence, post‐bronchodilator FEV1 < 70% predicted, near fatal asthma (intubation or ICU admission for asthma) within 2 yrs of enrolment, high risk of near fatal or fatal asthma, history of known premature birth less than 33 weeks or any significant level of respiratory care including prolonged oxygen administration or mechanical ventilation during the neonatal period, unstable cardiac disease (decompensated congestive heart failure, unstable angina, recent myocardial infarction, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension), other major chronic illnesses, drug allergies, pregnancy, lactation

Interventions

Stepping down from fluticasone/salmeterol Diskus 250/50 mcg twice a day to fluticasone Diskus 250 mcg twice a day without salmeterol

Outcomes

Primary: Rate of treatment failures (decline in peak flow or FEV1, increased need for beta agonists, requirement for non‐scheduled medical care for asthma symptoms, or prednisone taper)

Secondary: Pulmonary function (morning peak expiratory flow, pre‐bronchodilator FEV1), episodes of poor asthma control defined by unscheduled medical care, hospitalisation, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate

Starting date

March 2012

Contact information

Joy Saams, Registered Nurse

Notes

Estimated enrolment: 450. Estimated study completion date: June 2015

May be able to obtain data for children and adolescents separately from the adult participants

Results of the search and study selection process
Figuras y tablas -
Figure 1

Results of the search and study selection process

Stopping long‐acting beta2‐agonists (LABA) compared with continuing inhaled corticosteroids (ICS) + LABA for children with well‐controlled asthma

Patient or population: children (aged 18 years or younger) whose asthma is well controlled on combination ICS + LABA

Settings: outpatient

Intervention: stopping LABA

Comparison: continuing ICS + LABA

Outcomes

No of Participants
(studies)

Comments

Exacerbations requiring systemic corticosteroids

0 (0)

No studies met the inclusion criteria for the review

Asthma control (validated scales)

0 (0)

Serious adverse events (all cause)

0 (0)

Quality of life (validated scales)

0 (0)

Exacerbations requiring hospitalisation or emergency department visit

0 (0)

Adverse events (all cause)

0 (0)

Withdrawals

0 (0)

Figuras y tablas -