Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: Pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT)

Respiratory Research

Volumn 16, Issue 1, 2015, Pages

  Bateman, Eric D ^a   Chapman, Kenneth R ^b   Singh, Dave ^c   D'Urzo, Anthony D ^d   Molins, Eduard ^e   Leselbaum, Anne ^f   Gil, Esther Garcia ^e  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b TORONTO WESTERN HOSPITAL   (Canada)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

^d UNIVERSITY OF TORONTO   (Canada)

^e Almirall Prodesfarma S A   (Spain)

^f NONE   (Spain)

Author keywords

Aclidinium bromide formoterol fumarate; Chronic obstructive pulmonary disease; Fixed dose combination; Symptoms

Indexed keywords

ACLIDINIUM BROMIDE PLUS FORMOTEROL FUMARATE; PLACEBO; ACLIDINIUM BROMIDE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; DRUG COMBINATION; FORMOTEROL FUMARATE; HYPOCHOLESTEROLEMIC AGENT; TROPANE DERIVATIVE;

ADULT; AGED; ANTIINFLAMMATORY ACTIVITY; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL STUDY; CONTROLLED STUDY; COUGHING; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DYSPNEA; EARLY-MORNING SYMPTOM; EXACERBATIONS OF CHRONIC PULMONARY DISEASE TOOL [EXACT]-RESPIRATORY SYMPTOMS QUESTIONNAIRE; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEALTHCARE RESOURCE UTILISATION QUESTIONNAIRE; HUMAN; LIMITATION OF EARLY-MORNING ACTIVITY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NIGHT-TIME SYMPTOM; NOCTURAL AWAKENING; PHASE 3 CLINICAL TRIAL; PHLEGM; POOLED ANALYSIS; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCORING SYSTEM; SECRETION (PROCESS); SYMPTOMATOLOGY; TRANSITION DYSPNPEA INDEX; TREATMENT DURATION; TREATMENT OUTCOME; WHEEZING; CLINICAL TRIAL; DISEASE COURSE; DRUG COMBINATION; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TIME FACTOR;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; AGED; ANTICHOLESTEREMIC AGENTS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; FORMOTEROL FUMARATE; HUMANS; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TIME FACTORS; TROPANES;

EID: 84938700618     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/s12931-015-0250-2     Document Type: Article

References (39)

1. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20:183-94.
2. Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin. 2009;25:2043-8.
3. Price D, Small M, Milligan G, Higgins V, Garcia Gil E, Estruch J. Impact of night-time symptoms in COPD: a real-world study in five European countries. Int J Chron Obstruct Pulmon Dis. 2013;8:595-603.
4. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2015 [ http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Apr2.pdf ].
5. Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med. 2008;178:332-8.
6. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002;57:847-52.
7. Halpin DM, Decramer M, Celli B, Kesten S, Liu D, Tashkin DP. Exacerbation frequency and course of COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:653-61.
8. Jones PW, Lamarca R, Chuecos F, Singh D, Agustí A, Bateman ED, et al. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014;44:1156-65.
9. Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;157:1418-22.
10. Xu W, Collet JP, Shapiro S, Lin Y, Yang T, Wang C, et al. Negative impacts of unreported COPD exacerbations on health-related quality of life at 1 year. Eur Respir J. 2010;35:1022-30.
11. Miravitlles M, Worth H, Soler-Cataluna JJ, Price D, De Benedetto F, Roche F, et al. Observational study to characterise 24-hour COPD symptoms: cross-sectional results from the ASSESS study [poster]. London, UK: Presented at the British Thoracic Society Winter Meeting; 2013.
12. Roche N, Small M, Broomfield S, Higgins V, Pollard R. Real world COPD: association of morning symptoms with clinical and patient reported outcomes. COPD. 2013;10:679-86.
13. Yu AP, Guerin A, Ponce de Leon D, Ramakrishnan K, Wu EQ, Mocarski M, et al. Therapy persistence and adherence in patients with chronic obstructive pulmonary disease: multiple versus single long-acting maintenance inhalers. J Med Econ. 2011;14:486-96.
14. Chrischilles E, Gilden D, Kubisiak J, Rubenstein L, Shah H. Delivery of ipratropium and albuterol combination therapy for chronic obstructive pulmonary disease: effectiveness of a two-in-one inhaler versus separate inhalers. Am J Manag Care. 2002;8:902-11.
15. Bateman ED, Ferguson GT, Barnes N, Gallagher N, Green Y, Henley M, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013;42:1484-94.
16. Donohue JF, Maleki-Yazdi MR, Kilbride S, Mehta R, Kalberg C, Church A. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013;107:1538-46.
17. Buhl R, Maltais F, Abrahams R, Bjermer L, Derom E, Ferguson G, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015;45:969-79.
18. Chapman KR, Bateman ED, Chen H, Hu H, Fogel R, Banerji D. QVA149 improves lung function, dyspnea, and health status inpendent of previously prescribed medications and COPD severity: A subgroup analysis from the SHINE and ILLUMINATE studies. J COPD F. 2015;2:48-60.
19. Donohue JF, Niewoehner D, Brooks J, O'Dell D, Church A. Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study. Respir Res. 2014;15:78.
20. Westwood M, Bourbeau J, Jones PW, Cerulli A, Capkun-Niggli G, Worthy G. Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review. Respir Res. 2011;12:40.
21. Jones PW, Beeh KM, Chapman KR, Decramer M, Mahler DA, Wedzicha JA. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med. 2014;189:250-5.
22. AstraZeneca. Duaklir® Genuair® approved in the European Union for chronic obstructive pulmonary disease. 2014 [ http://www.astrazeneca.com/Media/Press-releases/Article/20141124--duaklir-genuair-approved-in-the-european-union ].
23. D'Urzo AD, Rennard SI, Kerwin EM, Mergel V, Leselbaum AR, Caracta CF. Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir Res. 2014;15:123.
24. Singh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, et al. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014;14:178.
25. Leidy NK, Wilcox TK, Jones PW, Roberts L, Powers JH, Sethi S. Standardizing measurement of chronic obstructive pulmonary disease exacerbations: reliability and validity of a patient-reported diary. Am J Respir Crit Care Med. 2011;183:323-9.
26. Leidy NK, Murray LT. Patient-reported outcome (PRO) measures for clinical trials of COPD: the EXACT and E-RS. COPD. 2013;10:393-8.
27. Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, et al. Measuring respiratory symptoms of COPD: performance of the EXACT-Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014;15:124.
28. Hareendran A, Palsgrove AC, Mocarski M, Schaefer ML, Setyawan J, Carson R, et al. The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2013;11:104.
29. Palsgrove A, Houghton K, Hareendran A, Schaefer M, Setyawan J, Mocarski M, et al. The development of the Early Morning Symptoms of COPD Instrument (EMSCI) [poster] Madrid, Spain: Presented at the International Society for Pharmacoeconomics and Outcomes Research Annual European Congress; 2011.
30. Han MK, Muellerova H, Curran-Everett D, Dransfield MT, Washko GR, Regan EA, et al. GOLD 2011 disease severity classification in COPDGene: a prospective cohort study. Lancet Respir Med. 2013;1:43-50.
31. Tashkin DP, Ferguson GT. Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease. Respir Res. 2013;14:49.
32. GlaxoSmithKline. Anoro® Ellipta® Summary of Product Characteristics. 2015 [ https://www.medicines.org.uk/emc/medicine/28949/ ].
33. Novartis. Patient information leaflet Ultibro® Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules. 2014 [ www.medicines.org.uk/emc/medicine/29534 ].
34. Watz H, Pitta F, Rochester CL, Garcia-Aymerich J, ZuWallack R, Troosters T, et al. An official European Respiratory Society statement on physical activity in COPD. Eur Respir J. 2014;Epub ahead of print.
35. Beier J, Kirsten AM, Mróz R, Segarra R, Chuecos F, Caracta C, et al. 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;10:511-22.
36. Campbell M, Eliraz A, Johansson G, Tornling G, Nihlén U, Bengtsson T, et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med. 2005;99:1511-20.
37. Rennard SI, Tashkin DP, McElhattan J, Goldman M, Ramachandran S, Martin UJ, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial. Drugs. 2009;69:549-65.
38. Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1:199-209.
39. Alsaeedi A, Sin DD, McAlister FA. The effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a systematic review of randomized placebo-controlled trials. Am J Med. 2002;113:59-65.