Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: The 24-week, randomized, placebo-controlled AUGMENT COPD study

Respiratory Research

Volumn 15, Issue 1, 2014, Pages

  D'Urzo, Anthony D ^a   Rennard, Stephen I ^b   Kerwin, Edward M ^c   Mergel, Victor ^d   Leselbaum, Anne R ^e   Caracta, Cynthia F ^d   Chatterjea, Debika ^f   Andersen, Kristen A ^f  

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^c Clinical Research Institute   (United States)

^d FOREST RESEARCH INSTITUTE   (United States)

^e Almirall ^*  (Spain)

^f NONE   (United States)

Author keywords

Aclidinium; COPD; Dyspnea; Formoterol; Health status; Lung function

Indexed keywords

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

ADULT; ARTICLE; ATRIAL FIBRILLATION; BRONCHODILATATION; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; DISEASE SEVERITY; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRY POWDER INHALER; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEADACHE; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MALE; MUSCLE SPASM; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; ST. GEORGE RESPIRATORY QUESTIONNAIRE; TREATMENT DURATION; TREATMENT RESPONSE; AGED; AUSTRALIA; CLINICAL TRIAL; CONVALESCENCE; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; LUNG; MIDDLE AGED; MULTICENTER STUDY; NEW ZEALAND; NORTH AMERICA; PATHOPHYSIOLOGY; PHASE 3 CLINICAL TRIAL; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TIME; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; AGED; AUSTRALIA; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; DRY POWDER INHALERS; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; FORMOTEROL FUMARATE; HEALTH STATUS; HUMANS; LUNG; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; NEW ZEALAND; NORTH AMERICA; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RECOVERY OF FUNCTION; TIME FACTORS; TREATMENT OUTCOME; TROPANES;

EID: 84965085606     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/s12931-014-0123-0     Document Type: Article

References (43)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD): Global strategy for the diagnosis, management and prevention of COPD (2014 update). [], [ http://www.goldcopd.org/ ]
2. Rabe KF, Timmer W, Sagkriotis A, Viel K: Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest. 2008, 134: 255-262. 10.1378/chest.07-2138.
3. van Noord JA, Aumann JL, Janssens E, Smeets JJ, Verhaert J, Disse B, Mueller A, Cornelissen PJ: Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J. 2005, 26: 214-222. 10.1183/09031936.05.00140404.
4. Wang J, Jin D, Zuo P, Wang T, Xu Y, Xiong W: Comparison of tiotropium plus formoterol to tiotropium alone in stable chronic obstructive pulmonary disease: a meta-analysis. Respirology. 2011, 16: 350-358. 10.1111/j.1440-1843.2010.01912.x.
5. Mahler DA, D'Urzo A, Bateman ED, Ozkan SA, White T, Peckitt C, Lassen C, Kramer B: Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax. 2012, 67: 781-788. 10.1136/thoraxjnl-2011-201140.
6. van Noord JA, Aumann JL, Janssens E, Verhaert J, Smeets JJ, Mueller A, Cornelissen PJ: Effects of tiotropium with and without formoterol on airflow obstruction and resting hyperinflation in patients with COPD. Chest. 2006, 129: 509-517. 10.1378/chest.129.3.509.
7. D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C: One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013, 10: 500-510. 10.3109/15412555.2013.791809.
8. Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falques 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. 10.1378/chest.11-0406.
9. Gelb AF, Tashkin DP, Make BJ, Zhong X, Garcia Gil E, Caracta C: Long-term safety and efficacy of twice-daily aclidinium bromide in patients with COPD. Respir Med. 2013, 107: 1957-1965. 10.1016/j.rmed.2013.07.001.
10. 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. 10.1183/09031936.00225511.
11. Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF: Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012, 9: 90-101. 10.3109/15412555.2012.661492.
12. Foradil prescribing information. [], [ http://www.merck.com/product/usa/pi_circulars/f/foradil/foradil_pi.pdf ]
13. Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C: Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011, 105: 580-587. 10.1016/j.rmed.2010.11.019.
14. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P: Standardisation of spirometry. Eur Respir J. 2005, 26: 319-338. 10.1183/09031936.05.00034805.
15. Leidy NK, Murray LT: Patient-reported outcome (PRO) measures for clinical trials of COPD: the EXACT and E-RS. COPD. 2013, 10: 393-398. 10.3109/15412555.2013.795423.
16. Hareendran A, Palsgrove A, Mocarski M, Schaefer M, Setyawan J, Carson R, Make BJ: The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2013, 11: 104-112. 10.1186/1477-7525-11-104.
17. Mocarski M, Hareendran A, Jen M-H, Zaiser E, Make BJ: Evaluation of the Psychometric Properties of the Nighttime Symptoms of COPD Instrument (NiSCI) [abstract]. Am J Respir Crit Care Med. 2014, 189: A5843-
18. Mocarski M, Hareendran A, Jen M-H, Zaiser E, Make BJ: Evaluation of the Psychometric Properties of the Early Morning Symptoms of COPD Instrument (EMSCI) [abstract]. Value Health. 2014, 17 (3): A179-10.1016/j.jval.2014.03.1044.
19. Jones PW: St. George's Respiratory Questionnaire: MCID. COPD. 2005, 2: 75-79. 10.1081/COPD-200050513.
20. Yu AP, Guerin A, Ponce de Leon D, Ramakrishnan K, Wu EQ, Mocarski M, Blum S, Setyawan J: Therapy persistence and adherence in patients with chronic obstructive pulmonary disease: multiple versus single long-acting maintenance inhalers. J Med Econ. 2011, 14: 486-496. 10.3111/13696998.2011.576295.
21. 2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther. 2010, 23: 257-267. 10.1016/j.pupt.2010.03.003.
22. Cazzola M, Di Marco F, Santus P, Boveri B, Verga M, Matera MG, Centanni S: The pharmacodynamic effects of single inhaled doses of formoterol, tiotropium and their combination in patients with COPD. Pulm Pharmacol Ther. 2004, 17: 35-39. 10.1016/j.pupt.2003.09.001.
23. FDA: Code of Federal Regulations (CFR Section 300.50): Fixed-combination prescription drugs for humans. [], [ http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol5/pdf/CFR-2011-title21-vol5-sec300-50.pdf ]
24. Benhamou D, Cuvelier A, Muir JF, Leclerc V, Le Gros V, Kottakis J, Bourdeix I: Rapid onset of bronchodilation in COPD: a placebo-controlled study comparing formoterol (Foradil Aerolizer) with salbutamol (Ventodisk). Respir Med. 2001, 95: 817-821. 10.1053/rmed.2001.1161.
25. Singh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, Caracta C, Garcia Gil E: Evaluation of the efficacy and safety of two doses of aclidinium and formoterol in fixed-dose combination in patients with COPD: the ACLIFORM study [abstract]. Chest. 2014, 145 (3): Suppl 375A-10.1378/chest.1796046.
26. 2-adrenoceptor agonist bronchodilator. Life Sci. 1993, 52: 2145-2160. 10.1016/0024-3205(93)90729-M.
27. Richter K, Stenglein S, Mucke M, Sieder C, Schmidtmann S, Harnest U, Weidinger G, Magnussen H: Onset and duration of action of formoterol and tiotropium in patients with moderate to severe COPD. Respiration. 2006, 73: 414-419. 10.1159/000091996.
28. Bourbeau J, Bartlett SJ: Patient adherence in COPD. Thorax. 2008, 63: 831-838. 10.1136/thx.2007.086041.
29. Make BJ: Chronic obstructive pulmonary disease: developing comprehensive management. Respir Care. 2003, 48: 1225-1234.
30. Mahler DA, Weinberg DH, Wells CK, Feinstein AR: The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984, 85: 751-758. 10.1378/chest.85.6.751.
31. Celli B, ZuWallack R, Wang S, Kesten S: Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest. 2003, 124: 1743-1748. 10.1378/chest.124.5.1743.
32. Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R: Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013, 187: 347-365. 10.1164/rccm.201204-0596PP.
33. Jones P, Beeh K, Chapman K, Decramer M, Mahler DA, Wedzicha J: Minimal Clinically Important Differences in Pharmacological Trials. Am J Respir Crit Care Med. 2014, 189: 250-255. 10.1164/rccm.201310-1863PP.
34. Mahler DA, Decramer M, D'Urzo A, Worth H, White T, Alagappan VK, Chen H, Gallagher N, Kulich K, Banerji D: Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study. Eur Respir J. 2014, 43: 1599-1609. 10.1183/09031936.00124013.
35. Calverley PM, Burge PS, Spencer S, Anderson JA, Jones PW: Bronchodilator reversibility testing in chronic obstructive pulmonary disease. Thorax. 2003, 58: 659-664. 10.1136/thorax.58.8.659.
36. Price D, Small M, Milligan G, Higgins V, Gil EG, 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. 10.2147/COPD.S48570.
37. Agusti A, Hedner J, Marin JM, Barbe F, Cazzola M, Rennard S: Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011, 20: 183-194. 10.1183/09059180.00004311.
38. 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. 10.1185/03007990903103006.
39. Tashkin DP, Pearle J, Iezzoni D, Varghese ST: Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. COPD. 2009, 6: 17-25. 10.1080/15412550902724073.
40. Rennard SI, Tashkin DP, McElhattan J, Goldman M, Ramachandran S, Martin UJ, Silkoff PE: 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: 549-565. 10.2165/00003495-200969050-00004.
41. Anzueto A, Ferguson GT, Feldman G, Chinsky K, Seibert A, Emmett A, Knobil K, O'Dell D, Kalberg C, Crater G: Effect of fluticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes. COPD. 2009, 6: 320-329. 10.1080/15412550903140881.
42. Campbell M, Eliraz A, Johansson G, Tornling G, Nihlen U, Bengtsson T, Rabe KF: Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med. 2005, 99: 1511-1520. 10.1016/j.rmed.2005.08.016.
43. Kerwin E, Rennard S, Gelb A, Rekeda L, Garcia Gil E, Caracta C: Twice-daily aclidinium bromide in COPD patients: nighttime symptoms and rescue medication use in ACCORD COPD I [abstract]. Am J Respir Crit Care Med. 2011, 183 (1): A1592-