Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials

The Lancet

Volumn 374, Issue 9691, 2009, Pages 685-694

  Calverley, Peter MA ^a   Rabe, Klaus F ^d   Goehring, Udo Michael ^e   Kristiansen, Søren ^e   Fabbri, Leonardo M ^c   Martinez, Fernando J ^b  

^a School of Veterinary Science University of Liverpool Leahurst Campus   (United Kingdom)

^b UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^c UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^e Nycomed   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; PLACEBO; ROFLUMILAST; SALBUTAMOL;

ADULT; AIRWAY OBSTRUCTION; ANOREXIA; ARTICLE; BACKACHE; BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; FEMALE; FORCED EXPIRATORY VOLUME; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HUMAN; HYPERTENSION; INFLUENZA; LUNG INFECTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTPATIENT; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SMOKING; SYMPTOM; THERAPY EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT REDUCTION;

EID: 69149103642     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(09)61255-1     Document Type: Article

References (33)

1. Kessler R., Stahl E., Vogelmeier C., et al. Patient understanding, detection, and experience of COPD exacerbations: an observational, interview-based study. Chest 130 (2006) 133-142
2. Donaldson G.C., Seemungal T.A., Bhowmik A., and Wedzicha J.A. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 57 (2002) 847-852
3. Soler-Cataluna J.J., Martinez-Garcia M.A., Roman S.P., Salcedo E., Navarro M., and Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 60 (2005) 925-931
4. Spencer S., Calverley P.M., Sherwood B.P., and Jones P.W. Health status deterioration in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 163 (2001) 122-128
5. Rabe K.F., Hurd S., Anzueto A., et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 176 (2007) 532-555
6. Brusasco V., Hodder R., Miravitlles M., Korducki L., Towse L., and Kesten S. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 58 (2003) 399-404
7. Calverley P.M., Anderson J.A., Celli B., et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 356 (2007) 775-789
8. Stockley R.A., Chopra N., and Rice L. Addition of salmeterol to existing treatment in patients with COPD: a 12 month study. Thorax 61 (2006) 122-128
9. Tashkin D.P., Celli B., Senn S., et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 359 (2008) 1543-1554
10. Bundschuh D.S., Eltze M., Barsig J., Wollin L., Hatzelmann A., and Beume R. In vivo efficacy in airway disease models of roflumilast, a novel orally active PDE4 inhibitor. J Pharmacol Exp Ther 297 (2001) 280-290
11. Hatzelmann A., and Schudt C. Anti-inflammatory and immunomodulatory potential of the novel PDE4 inhibitor roflumilast in vitro. J Pharmacol Exp Ther 297 (2001) 267-279
12. Spina D. PDE4 inhibitors: current status. Br J Pharmacol 155 (2008) 308-315
13. Grootendorst D.C., Gauw S.A., Verhoosel R.M., et al. Reduction in sputum neutrophil and eosinophil numbers by the PDE4 inhibitor roflumilast in patients with COPD. Thorax 62 (2007) 1081-1087
14. Calverley P.M., Sanchez-Toril F., McIvor A., Teichmann P., Bredenbroeker D., and Fabbri L.M. Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med 176 (2007) 154-161
15. Mahler D.A., Weinberg D.H., Wells C.K., and Feinstein A.R. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest 85 (1984) 751-758
16. Sin D.D., and Man S.F. Skeletal muscle weakness, reduced exercise tolerance, and COPD: is systemic inflammation the missing link?. Thorax 61 (2006) 1-3
17. Rabin R., and de C.F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 33 (2001) 337-343
18. Verbeke G., and Molenberghs G. Linear mixed models for longitudinal data. Series in Statistics (2000), Springer, New York
19. Rabe K.F., Bateman E.D., O'Donnell D., Witte S., Bredenbröker D., and Bethke T.D. Roflumilast-an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 366 (2005) 563-571
20. Snoeck-Stroband J.B., Lapperre T.S., Gosman M.M., et al. Chronic bronchitis sub-phenotype within COPD: inflammation in sputum and biopsies. Eur Respir J 31 (2008) 70-77
21. Assmann S.F., Pocock S.J., Enos L.E., and Kasten L.E. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 355 (2000) 1064-1069
22. Lanes S.F., and Jara M. The INSPIRE study: influence of prior use and discontinuation of inhaled corticosteroids. Am J Respir Crit Care Med 178 (2008) 543-544
23. Calverley P., Pauwels R., Vestbo J., et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 361 (2003) 449-456
24. Calverley P.M., Boonsawat W., Cseke Z., Zhong N., Peterson S., and Olsson H. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 22 (2003) 912-919
25. Calverley P.M., Rennard S., Nelson H.S., et al. One-year treatment with mometasone furoate in chronic obstructive pulmonary disease. Respir Res 9 (2008) 73
26. Casas J.P., Shah T., Hingorani A.D., Danesh J., and Pepys M.B. C-reactive protein and coronary heart disease: a critical review. J Intern Med 264 (2008) 295-314
27. Fabbri L.M., Calverley P.M., Izquierdo-Alonso J.L., et al., for the M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet 374 (2009) 695-703
28. Burge P.S., Calverley P., Jones P.W., Spencer S., Anderson J.A., and Maslen T.K. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 320 (2000) 1297-1303
29. Calverley P.M., and Walker P. Chronic obstructive pulmonary disease. Lancet 362 (2003) 1053-1061
30. Keene O.N., Calverley P.M., Jones P.W., Vestbo J., and Anderson J.A. Statistical analysis of exacerbation rates in COPD: TRISTAN and ISOLDE revisited. Eur Respir J 32 (2008) 17-24
31. Keene O.N., Calverley P.M., Jones P.W., Vestbo J., and Anderson J.A. Statistical analysis of COPD exacerbations. Eur Respir J 32 (2008) 1421-1422
32. Suissa S. Exacerbations and intent-to-treat analyses in randomised trials. Eur Respir J 32 (2008) 1117-1118
33. Wedzicha J.A., Calverley P.M., Seemungal T.A., Hagan G., Ansari Z., and Stockley R.A. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 177 (2008) 19-26