Use and Publications

EXACT and E-RS Overview

Leidy NK, Murray LT. Patient-reported outcome (PRO) measures for clinical trials of COPD: the EXACT and E-RS. COPD. Jun 2013;10(3):393-398. PubMed.

Bushnell DM, Wilson R, Gutzwiller FS, et al. Use of the Evaluating Respiratory Symptoms™ in COPD as an outcome measure in clinical trials: a rapid systematic review. Chronic Obstr Pulm Dis. 2021; 8(4): 551-571.
doi: http://doi.org/10.15326/jcopdf.2021.0235

Other EXACT Publications

Choi HS, Park YB, Shin KC, Jang SH, Choe KH, Kim YS, Kyung SY, Yooh SH, Kim JS and Jung SS. Exacerbations of Chronic Obstructive Pulmonary Disease Tool to assess the efficacy of acute treatment. Int J Chron Obstruct Pulmon Dis.. 2019 Feb 25;14:471-478. PubMed.

Germovsek E, Ambery C, Yang S, Beerahee M, Karlsson MO, and Plan EL. A Novel Method for Analysing Frequent Observations from Questionnaires in Order to Model Patient-Reported Outcomes: Application to EXACT® Daily Diary Data from COPD Patients. The AAPS Journal. 2019 Apr;21(4):60. PubMed.

Bowler R, Allinder M, Jacobson S, Miller A, Miller B, Tal-Singer R and Locantore N. Real-world use of rescue inhaler sensors, electronic symptom questionnaires and physical activity monitors in COPD. BMJ Open Respir Res.. 2019 Feb 18;6(1). PubMed.

Frent SM, Chapman KR, Larbig M, et al. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT: A Sub-Analysis of FLAME. Am J Respir Crit Care Med. 2018 July 18. PubMed.

Crook S, Büsching G, Keusch S, et al. The association between daily exacerbation symptoms and physical activity in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2018 Jul 18;13: 2199-2206. doi: 10.2147/COPD.S156986. eCollection 2018.PubMed.

Papi A, Dokic D, Tzimas W, Mészáros I, Olech-Cudzik A, Koroknai Z, McAulay K, Mersmann S, Dalvi PS, Overend T. Fluticasone propionate/formoterol for COPD management: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2017 Jul 5;12: 1961-1971. doi: 10.2147/COPD.S136527. eCollection 2017. PubMed.

Nelsen L, Gater A, Panter C, et al. Understanding and measuring symptoms and health status in asthma COPD overlap: content validity of the EXACT and SGRQ. J Patient Rep Outcomes 2017;2(1):18. doi: 10.1186/s41687-018-0038-5. Epub 2018 Apr 11. PubMed.

Nordenmark LH, Taylor R, Jorup C. Feasibility of computed tomography in a multicenter COPD trial: a study of the effect of AZD9668 on structural airway changes. Adv Ther. 2015 Jun;32(6):548-66. doi: 10.1007/s12325-015-0215-3. Epub 2015 Jun 5. PubMed.

Vanaparthy R, Mota P, Khan R, et al. A longitudinal assessment of sleep variables during exacerbations of chronic obstructive pulmonary disease.  Chron Respir Dis. 2015 Nov;12(4):299-304. doi: 10.1177/1479972315587517. Epub 2015 May 31.PubMed.

Jones PW, Lamarca R, Chuecos F, et al. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18. PubMed.

Wedzicha JA, Singh D, Vestbo J, et al. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153-62. doi: 10.1016/j.rmed.2014.05.013. Epub 2014 Jun 6.  Respir Med Article.

Mackay AJ, Donaldson GC, Patel AR, et al. Detection and severity grading of COPD exacerbations using the exacerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT). Eur Respir J. 2014 Mar;43(3):735-44. doi: 10.1183/09031936.00110913. Epub 2013 Aug 29. PubMed.

Mohan A, Sethi S. The reliability and validity of patient-reported chronic obstructive pulmonary disease exacerbations. Curr Opin Pulm Med. 2014 Mar;20(2):146-52. doi: 10.1097/MCP.0000000000000032. PubMed.

Ehsan M, Khan R, Wakefield D, et al. A longitudinal study evaluating the effect of exacerbations on physical activity in patients with chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2013 Dec;10(6):559-64. doi: 10.1513/AnnalsATS.201304-100OC. PubMed.

Singh D, Kampschulte J, Wedzicha JA, et al. A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations. Eur Respir J. 2013 Jan;41(1):12-7. doi: 10.1183/09031936.00207611. Epub 2012 May 31. Eur Respir J. Jan 2013;41(1):12-17. PubMed.

Halpin DM, Laing-Morton T, Spedding S, et al. A randomised controlled trial of the effect of automated interactive calling combined with a health risk forecast on frequency and severity of exacerbations of COPD assessed clinically and using EXACT PRO. Prim Care Respir J. 2011 Sep;20(3):324-31, 2 p following 331. doi: 10.4104/pcrj.2011.00057. Prim Care Respir J Article.

Petrillo J, Cairns J. Development of the EXACT-U: a preference-based measure to report COPD exacerbation utilities. Value Health. 2011 Jun;14(4):546-54. doi: 10.1016/j.jval.2010.10.032. Epub 2011 May 19. PubMed.

Other E-RS:COPD Publications

Tabberer, M., von Maltzahn, R., Bacci, E.D. et al. Measuring respiratory symptoms in moderate/severe asthma: evaluation of a respiratory symptom tool, the E-RS®: COPD in asthma populations. J Patient Rep Outcomes 5, 104 (2021). https://doi.org/10.1186/s41687-021-00338-6.

Lewthwaite H, Jensen D, Ekström M. How to Assess Breathlessness in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2021;16:1581-1598. Dovepress.

Sethi S, Kerwin E, Watz H, Ferguson GT, Mroz RM, Segarra R, Molins E, Jarreta D, Gil EG. AMPLIFY: a randomized, Phase III study evaluating the efficacy and safety of aclidinium/formoterol vs monocomponents and tiotropium in patients with moderate-to-very severe symptomatic COPD. International Journal of COPD. 2019;14:667. PubMed.

Smith JA, McGarvey L, Morice AH, Birring SS, Wedzicha JA, Notari M, Zapata A, Segarra R, Seoane B, Jarreta D. The Effect of Aclidinium on Symptoms Including Cough in COPD: A Phase IV, DoubleBlind, Placebo-Controlled, Parallel-Group Study. Am J Respir Crit Care Med. 2019. doi: 10.1164/rccm.201901-0048LE. Epub 2019 Apr 5. PubMed.

Nelsen LM, Lee LA, Wu W, Lin X, Murray L, Leidy N. Reliability, validity and responsiveness of E-RS:COPD in patients with spirometric asthma-COPD overlap: Evaluation of the E-RS to measure daily symptoms in patients with COPD with a reversible component. Respir Res.. 2019; 20(107): 2019 May 31. Respir Res.

Maltais F, Bjermer L, Kerwin EM, Jones PW, Watkins ML, Tombs L, Naya IP, Boucot IH, Lipson DA, Compton C, Vahdati-Bolouri M. Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial. Respir Res.. 2019 Dec 1;20(1):238. Respir Res.

Kerwin EM, Tosiello R, Price B, Sanjar S, Goodin T. Effect of background long-acting beta2-agonist therapy on the efficacy and safety of a novel, nebulized glycopyrrolate in subjects with moderate-to-very-severe COPD. International Journal of COPD. 2018;13:2917.PubMed.

Naya I, Compton C, Ismaila AS, Birk R, Brealey N, Tabberer M, Zhu CQ, Lipson DA, Criner G. Preventing clinically important deterioration with single-inhaler triple therapy in COPD. ERJ open research. 2018 Oct 1;4(4):00047-2018. 667. ERJ Open Research.

Tabberer M, Lomas DA, Birk R, Brealey N, Zhu CQ, Pasco S, Locantore N, Lipson DA. Once-daily triple therapy in patients with COPD: patient-reported symptoms and quality of life. Adv Ther. 2018 Jan;35(1):56-71. doi: 10.1007/s12325-017-0650-4. Epub 2018 Jan 8. PubMed.

Santus P, Radovanovic D, Cristiano A, Valenti V, Rizzi M. Role of nebulized glycopyrrolate in the treatment of chronic obstructive pulmonary disease. Drug design, development and therapy.. 2017;11:3257. Drug Design, Development and Therapy.

Kerwin E, Donohue JF, Goodin T, Tosiello R, Wheeler A, Ferguson GT. Efficacy and safety of glycopyrrolate/eFlow® CS (nebulized glycopyrrolate) in moderate-to-very-severe COPD: Results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017 Nov;132: 238-250. doi: 10.1016/j.rmed.2017.07.011. Epub 2017 Jul 19. PubMed.

Papi A, Dokic D, Tzimas W, Mészáros I, Olech-Cudzik A, Koroknai Z, McAulay K, Mersmann S, Dalvi PS, Overend T. Fluticasone propionate/formoterol for COPD management: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2017 Jul 5;12: 1961-1971. doi: 10.2147/COPD.S136527. eCollection 2017.  PubMed.

Lee L, Kerwin E, Collison K, Nelsen L, Wu W, Yang S, Pascoe S. The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study. Respir Med. 2017 Oct;131: 148-157. doi: 10.1016/j.rmed.2017.08.013. Epub 2017 Aug 14. PubMed.

Beier J, Mroz R, Kirsten AM, Chuecos F, Gil EG. Improvement in 24-hour bronchodilation and symptom control with aclidinium bromide versus tiotropium and placebo in symptomatic patients with COPD: post hoc analysis of a Phase IIIb study. Int J Chron Obstruct Pulmon Dis. 2017 Jun 14;12:1731-1740. doi: 10.2147/COPD.S121723. eCollection 2017. PubMed.

Jones PW, Leidy NK, Hareendran A, et al. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1. PubMed.

Miller B, Tal-Singer R, Lazaar A, Leidy N, Watz H, Collins D, et al. Assessing symptoms in COPD: Use of the E-RS daily digital diary in early drug development.Eur Respir J. 2016;48(suppl 60):PA1047. European Respiratory Journal.

Beier J, Kirsten AM, Mroz R, Segarra R, Chuecos F, Caracta C, Gil EG. Efficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: results from a 6-week, randomized, controlled Phase IIIb study.COPD. 2013 Aug;10(4):511-22. PubMed.