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: Journal of Chronic Obstructive Pulmonary Disease

Volumn 10, Issue 4, 2013, Pages 511-522

  Beier, Jutta ^a   Kirsten, Anne Marie ^b   Mrûz, Robert ^c   Segarra, Rosa ^d   Chuecos, Ferran ^d   Caracta, Cynthia ^e   Gil, Esther Garcia ^d  

^a Institut fur Atemwegsforschung INSAF   (Germany)

^b KRANKENHAUS GROSSHANSDORF   (Germany)

^c MEDICAL UNIVERSITY OF BIALYSTOK   (Poland)

^d Almirall ^*  (Spain)

^e FOREST RESEARCH INSTITUTE   (United States)

Author keywords

24 hour; Bronchodilation; Long acting muscarinic antagonist; Nighttime; Symptoms

Indexed keywords

ACLIDINIUM BROMIDE; PLACEBO; TIOTROPIUM BROMIDE;

ADULT; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; EVENING DOSAGE; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TREATMENT DURATION; XEROSTOMIA;

AGED; AREA UNDER CURVE; BRONCHODILATOR AGENTS; CIRCADIAN RHYTHM; COUGH; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRY POWDER INHALERS; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PATIENT PREFERENCE; PHARYNGITIS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUESTIONNAIRES; RESPIRATORY SOUNDS; SCOPOLAMINE DERIVATIVES; TIME FACTORS; TROPANES; XEROSTOMIA;

EID: 84880746971     PISSN: 15412555     EISSN: 15412563     Source Type: Journal    
DOI: 10.3109/15412555.2013.814626     Document Type: Article

References (39)

1. Postma DS, Koëter GH, vd Mark TW, Reig RP, Sluiter HJ. The effects of oral slow-release terbutaline on the circadian variation in spirometry and arterial blood gas levels in patients with chronic airfl ow obstruction. Chest 1985; 87:653-657.
2. Calverley PM, Lee A, Towse L, van Noord J, Witek TJ, Kelsen S. Effect of tiotropium bromide on circadian variation in airfl ow limitation in chronic obstructive pulmonary disease. Thorax 2003; 58:855-860.
3. van Noord JA, Aumann JL, Janssens E, Verhaert J, Smeets JJ, Mueller A, Cornelissen PJ. Effects of tiotropium with and without formoterol on airfl ow obstruction and resting hyperinfl ation in patients with COPD. Chest 2006; 129:509-517.
4. Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J 2011; 37:264-272.
5. 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; 25:2043-2048.
6. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Nighttime symptoms: a forgotten dimension of COPD. Eur Respir Rev 2011; 20:183-194.
7. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis- management.html (accessed February 2013).
8. Donohue JF, van Noord JA, Bateman ED, Langley SJ, Lee A, Witek TJ, Jr., Kesten S, Towse L. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002; 122:47-55.
9. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/002211/human-med-001571. jsp&mid=WC0b01ac058001d124 (accessed March 2013).
10. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index. cfm?fuseaction=Search.DrugDetails (accessed March 2013).
11. Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falqués M, Caracta CF, Garcia Gil E. Efficacy of aclidinium bromide 400 μg twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest 2012; 141:745-752.
12. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. www.goldcopd.com 2010.
13. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten C P, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J. Standardisation of spirometry. Eur Respir J 2005; 26:319-338.
14. Murray L, Houle C, Stolar M, Hsieh R, Jones PW, Monz BU, Ramachandran S, Goldman M, Sethi S, Leidy NK. Quantifying the severity of respiratory symptoms of chronic obstructive pulmonary disease (COPD): performance properties of the EXAcerbations of Chronic pulmonary disease Tool-Respiratory Symptoms (E-RS) in 3 randomized controlled trials. Am J Resp Crit Care Med 2012; 185:A1515.
15. Cazzola M, MacNee W, Martinez FJ, Rabe KF, Franciosi LG, Barnes PJ, Brusasco V, Burge PS, Calverley PM, Celli BR, Jones PW, Mahler DA, Make B, Miravitlles M, Page CP, Palange P, Parr D, Pistolesi M, Rennard SI, Rutten-van Mölken M P, Stockley R, Sullivan SD, Wedzicha JA, Wouters EF. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J 2008; 31:416-469.
16. Donohue JF. Minimal clinically important differences in COPD lung function. COPD 2005; 2:111-124.
17. http://www.spiriva.com/(accessed March 2013).
18. Lasseter KC, Dilzer S, Jansat JM, Garcia Gil E, Caracta C, Ortiz S. Safety and pharmacokinetics of multiple doses of aclidinium bromide administered twice daily in healthy volunteers. Pulm Pharmacol Ther 2012; 25:193-199.
19. Mocarski M, Caracta C, Tourkodimitris S, Park G, Garcia Gil E, Setyawan J. Nighttime symptoms of COPD in a clinical trial population: prevalence and impact. Am J Resp Crit Care Med 2011; 183, abs A1495.
20. Martin RJ, Bartelson BL, Smith P, Hudgel DW, Lewis D, Pohl G, Koker P, Souhrada JF. Effect of ipratropium bromide treatment on oxygen saturation and sleep quality in COPD. Chest 1999; 115:1338-1345.
21. McNicholas WT, Calverley PM, Lee A, Edwards JC. Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD. Eur Respir J 2004; 23:825-831.
22. Mulloy E, McNicholas WT. Theophylline improves gas exchange during rest, exercise, and sleep in severe chronic obstructive pulmonary disease. Am Rev Respir Dis 1993; 148:1030-1036.
23. Ryan S, Doherty LS, Rock C, Nolan GM, McNicholas WT. Effects of salmeterol on sleeping oxygen saturation in chronic obstructive pulmonary disease. Respiration 2010; 79:475-481.
24. Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: The ATTAIN study. Eur Respir J 2012; 40:830-836.
25. Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF, ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012; 9:90-101.
26. Agusti A, Jones PW, Bateman ED, Singh D, Lamarca R, de Miquel G, Caracta C, Garcia Gil E. Improvement in symptoms and rescue medication use with aclidinium bromide in patients with chronic obstructive pulmonary disease: results from ATTAIN. Eur Respir J 2011; 38:149.
27. Kerwin E, Rennard S, Gelb AF, Rekeda L, Garcia Gil E, Caracta C. ACCORD COPD I: improvements in nighttime symptoms and rescue medication use in COPD with twice-daily aclidinium bromide. Poster presented at the European Respiratory Society Annual Congress, Amsterdam, The Netherlands, 24-28 September, 2011.
28. http://www.exactproinitiative.com/default.php (accessed April 2013).
29. Toy EL, Beaulieu NU, McHale JM, Welland TR, Plauschinat CA, Swensen A, Duh MS. Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs. Respir Med 2011; 105:435-441.
30. Chrystyn H, Small M, Milligan G, Higgins V, Garcia Gil E, Karakurum C. Impact of patient satisfaction with their maintenance inhaler on treatment compliance and health outcomes in chronic obstructive pulmonary disease: an analysis of real-world clinical practice in Europe. Abstract presented at the British Thoracic Society Winter Meeting, London, UK, 5-7 December 2012.
31. Lareau SC, Yawn BP. Improving adherence with inhaler therapy in COPD. Int J Chron Obstruct Pulmon Dis 2010; 5:401-406.
32. Restrepo RD, Alvarez MT, Wittnebel LD, Sorenson H, Wettstein R, Vines DL, Sikkema-Ortiz J, Gardner DD, Wilkins RL. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis 2008; 3:371-384.
33. van der Palen J, Ginko T, Kroker A, van der Valk P, Goosens M, Padulles L, Seoane B, Rekeda L, Garcia-Gil E. Preference, satisfaction and critical errors with Genuair® and HandiHaler® in patients with COPD. Eur Respir J 2012; 40 (Suppl 56): 389s.
34. Gavaldà A, Sentellas S, Albertí J, Miralpeix M, Antón F, Salvà M, Beleta J. Rapid plasma hydrolysis of aclidinium bromide, a novel long-acting anticholinergic drug. Poster presented at the European Respiratory Society Annual Congress, Berlin, Germany, 4-8 October, 2008.
35. Sentellas S, Ramos I, Albertí J, Salvà M, Antón F, Miralpeix M, Beleta J, Gavaldà A. Aclidinium bromide, a new, long-acting, inhaled muscarinic antagonist: in vitro plasma inactivation and pharmacological activity of its main metabolites. Eur J Pharm Sci 2010; 39:283-290.
36. Dong YH, Lin HH, Shau WY, Wu YC, Chang CH, Lai MS. Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials. Thorax 2013; 68:48-56.
37. Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012; 7:CD009285.
38. Singh S, Loke YK, Enright PL, Furberg CD. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011; 342:d3215.
39. Kesten S, Jara M, Wentworth C, Lanes S. Pooled clinical trial analysis of tiotropium safety. Chest 2006; 130:1695-1703.