-
1
-
-
69149103642
-
Roflumilast in symptomatic chronic obstructive pulmonary disease: Two randomised clinical trials
-
M2-124 and M2-125 study groups. doi:10. 1016/S0140-6736(09)61255-1 PubMed
-
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009; 374: 685-694. doi:10. 1016/S0140-6736(09)61255-1 PubMed
-
(2009)
Lancet
, vol.374
, pp. 685-694
-
-
Calverley, P.M.1
Rabe, K.F.2
Goehring, U.M.3
Kristiansen, S.4
Fabbri, L.M.5
Martinez, F.J.6
-
2
-
-
69149098943
-
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: Two randomised clinical trials
-
M2-127 and M2-128 study groups. doi:10.1016/S0140-6736(09)61252-6 PubMed
-
Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; 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. 2009; 374: 695-703. doi:10.1016/S0140-6736(09)61252-6 PubMed
-
(2009)
Lancet
, vol.374
, pp. 695-703
-
-
Fabbri, L.M.1
Calverley, P.M.2
Izquierdo-Alonso, J.L.3
Bundschuh, D.S.4
Brose, M.5
Martinez, F.J.6
Rabe, K.F.7
-
3
-
-
0035084103
-
Anti-inflammatory and immunomodulatory potential of the novel PDE4 inhibitor roflumilast in vitro
-
PubMed
-
Hatzelmann A, Schudt C. Anti-inflammatory and immunomodulatory potential of the novel PDE4 inhibitor roflumilast in vitro. J Pharmacol Exp Ther. 2001; 297: 267-279. PubMed
-
(2001)
J Pharmacol Exp Ther
, vol.297
, pp. 267-279
-
-
Hatzelmann, A.1
Schudt, C.2
-
4
-
-
33845764714
-
Dose-proportional intraindividual single- and repeated-dose pharmacokinetics of roflumilast, an oral, once-daily phosphodiesterase 4 inhibitor
-
doi:10.1177/0091270006294529 PubMed
-
Bethke TD, Böhmer GM, Hermann R, Hauns B, Fux R, Mörike K, David M, Knoerzer D, Wurst W, Gleiter CH. Dose-proportional intraindividual single- and repeated-dose pharmacokinetics of roflumilast, an oral, once-daily phosphodiesterase 4 inhibitor. J Clin Pharmacol. 2007; 47: 26-36. doi:10.1177/0091270006294529 PubMed
-
(2007)
J Clin Pharmacol
, vol.47
, pp. 26-36
-
-
Bethke, T.D.1
Böhmer, G.M.2
Hermann, R.3
Hauns, B.4
Fux, R.5
Mörike, K.6
David, M.7
Knoerzer, D.8
Wurst, W.9
Gleiter, C.H.10
-
5
-
-
0035078823
-
In vivo efficacy in airway disease models of roflumilast, a novel orally active PDE4 inhibitor
-
PubMed
-
Bundschuh DS, Eltze M, Barsig J, Wollin L, Hatzelmann A, Beume R. In vivo efficacy in airway disease models of roflumilast, a novel orally active PDE4 inhibitor. J Pharmacol Exp Ther. 2001; 297: 280-290. PubMed
-
(2001)
J Pharmacol Exp Ther
, vol.297
, pp. 280-290
-
-
Bundschuh, D.S.1
Eltze, M.2
Barsig, J.3
Wollin, L.4
Hatzelmann, A.5
Beume, R.6
-
6
-
-
34247618325
-
Steady-state pharmacokinetics of roflumilast and roflumilast N-oxide in patients with mild and moderate liver cirrhosis
-
PubMed doi:10.2165/00003088-20074605000003
-
Hermann R, Nassr N, Lahu G, Péterfai E, Knoerzer D, Herzog R, Zech K, de Mey C. Steady-state pharmacokinetics of roflumilast and roflumilast N-oxide in patients with mild and moderate liver cirrhosis. Clin Pharmacokinet. 2007; 46: 403-416. PubMed doi:10.2165/00003088-20074605000003
-
(2007)
Clin Pharmacokinet
, vol.46
, pp. 403-416
-
-
Hermann, R.1
Nassr, N.2
Lahu, G.3
Péterfai, E.4
Knoerzer, D.5
Herzog, R.6
Zech, K.7
De Mey, C.8
-
7
-
-
0037445151
-
Theophylline: New perspectives for an old drug
-
doi:10.1164/rccm.200210-1142PP PubMed
-
Barnes PJ. Theophylline: new perspectives for an old drug. Am J Respir Crit Care Med. 2003; 167: 813-818. doi:10.1164/rccm.200210-1142PP PubMed
-
(2003)
Am J Respir Crit Care Med
, vol.167
, pp. 813-818
-
-
Barnes, P.J.1
-
8
-
-
79955690629
-
-
European Medicines Agency. (CPMP/EWP/560/95/Rev. 1 - Corr.*). London
-
European Medicines Agency. Guideline on the investigation of drug interactions (CPMP/EWP/560/95/Rev. 1 - Corr.*). London; 2010.
-
(2010)
Guideline on the Investigation of Drug Interactions
-
-
-
10
-
-
0028927771
-
Influence of endogenous and exogenous effectors on the pharmacokinetics of theophylline. Focus on biotransformation
-
doi:10.21 65/00003088-199528040-00003 PubMed
-
Tröger U, Meyer FP. Influence of endogenous and exogenous effectors on the pharmacokinetics of theophylline. Focus on biotransformation. Clin Pharmacokinet. 1995; 28: 287-314. doi:10.21 65/00003088-199528040-00003 PubMed
-
(1995)
Clin Pharmacokinet
, vol.28
, pp. 287-314
-
-
Tröger, U.1
Meyer, F.P.2
-
11
-
-
12144271293
-
Efficacy of theophylline in people with stable chronic obstructive pulmonary disease: A systematic review and meta-analysis
-
doi:10.1016/j.rmed.2004.10.009 PubMed
-
Ram FS, Jardin JR, Atallah A, Castro AA, Mazzini R, Goldstein R, Lacasse Y, Cendon S. Efficacy of theophylline in people with stable chronic obstructive pulmonary disease: a systematic review and meta-analysis. Respir Med. 2005; 99: 135-144. doi:10.1016/j.rmed.2004.10.009 PubMed
-
(2005)
Respir Med
, vol.99
, pp. 135-144
-
-
Ram, F.S.1
Jardin, J.R.2
Atallah, A.3
Castro, A.A.4
Mazzini, R.5
Goldstein, R.6
Lacasse, Y.7
Cendon, S.8
-
12
-
-
0024986395
-
Adverse reactions and interactions with theophylline
-
doi:10.2165/00002018-199005040-00004 PubMed
-
Skinner MH. Adverse reactions and interactions with theophylline. Drug Saf. 1990; 5: 275-285. doi:10.2165/00002018-199005040-00004 PubMed
-
(1990)
Drug Saf
, vol.5
, pp. 275-285
-
-
Skinner, M.H.1
-
13
-
-
33847726335
-
First-line therapy for theophylline-associated seizures
-
DOI 10.1111/j.1600-0404.2007.00810.x
-
Yoshikawa H. First-line therapy for theophylline-associated seizures. Acta Neurol Scand. 2007; 115 (Suppl): 57-61. doi:10.1111/j.1600-0404.2007.00810. x PubMed (Pubitemid 46376172)
-
(2007)
Acta Neurologica Scandinavica
, vol.115
, Issue.SUPPL.186
, pp. 57-61
-
-
Yoshikawa, H.1
-
15
-
-
0029878681
-
Theophylline in asthma
-
doi: 10.1056/NEJM199605233342107 PubMed
-
Weinberger M, Hendeles L. Theophylline in asthma. N Engl J Med. 1996; 334: 1380-1388. doi: 10.1056/NEJM199605233342107 PubMed
-
(1996)
N Engl J Med
, vol.334
, pp. 1380-1388
-
-
Weinberger, M.1
Hendeles, L.2
-
16
-
-
38449114426
-
A meta-analysis on the efficacy of oral theophylline in patients with stable COPD
-
doi:10.2147/copd.2006.1.3.261 Pub Med
-
Molfino NA, Zhang P. A meta-analysis on the efficacy of oral theophylline in patients with stable COPD. Int J Chron Obstruct Pulmon Dis. 2006; 1: 261-266. doi:10.2147/copd.2006.1.3.261 Pub Med
-
(2006)
Int J Chron Obstruct Pulmon Dis
, vol.1
, pp. 261-266
-
-
Molfino, N.A.1
Zhang, P.2
-
17
-
-
34147214922
-
-
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Gig Harbor WA: Medical Communications Resources Inc.
-
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for diagnosis, management, and prevention of COPD. Gig Harbor WA: Medical Communications Resources Inc.; 2009.
-
(2009)
Global Strategy for Diagnosis, Management, and Prevention of COPD
-
-
-
18
-
-
60249098268
-
Geographic differences in clinical characteristics and management of COPD: The EPOCA study
-
PubMed
-
Miravitlles M, Murio C, Tirado-Conde G, Levy G, Muellerova H, Soriano JB, Ramirez-Venegas A, Ko FW, Canelos-Estrella B, Giugno E, Bergna M, Chérrez I, Anzueto A. Geographic differences in clinical characteristics and management of COPD: the EPOCA study. Int J Chron Obstruct Pulmon Dis. 2008; 3: 803-814. PubMed
-
(2008)
Int J Chron Obstruct Pulmon Dis
, vol.3
, pp. 803-814
-
-
Miravitlles, M.1
Murio, C.2
Tirado-Conde, G.3
Levy, G.4
Muellerova, H.5
Soriano, J.B.6
Ramirez-Venegas, A.7
Ko, F.W.8
Canelos-Estrella, B.9
Giugno, E.10
Bergna, M.11
Chérrez, I.12
Anzueto, A.13
-
20
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
-
doi:10.1007/BF01068419 PubMed
-
Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987; 15: 657-680. doi:10.1007/BF01068419 PubMed
-
(1987)
J Pharmacokinet Biopharm
, vol.15
, pp. 657-680
-
-
Schuirmann, D.J.1
-
22
-
-
79958801036
-
Effect of steadystate enoxacin on single-dose pharmacokinetics of roflumilast and roflumilast N-oxide
-
Epub ahead of print
-
Lahu G, Nassr N, Herzog R, Elmlinger M, Ruth P, Hinder M and Huennemeyer A. Effect of steadystate enoxacin on single-dose pharmacokinetics of roflumilast and roflumilast N-oxide. J Clin Pharm. 2010; [Epub ahead of print].
-
(2010)
J Clin Pharm
-
-
Lahu, G.1
Nassr, N.2
Herzog, R.3
Elmlinger, M.4
Ruth, P.5
Hinder, M.6
Huennemeyer, A.7
-
23
-
-
67649932264
-
-
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). CPMP/EWP/QWP/1401/98 Rev. 1/ Corr.**. London
-
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1/ Corr.**). London; 2010.
-
(2010)
Guideline on the Investigation of Bioequivalence
-
-
-
24
-
-
24744457296
-
Assessment of CYP1A2 activity in clinical practice: Why, how, and when?
-
doi:10.1111/j.1742-7843.2005.pto-973160.x PubMed
-
Faber MS, Jetter A, Fuhr U. Assessment of CYP1A2 activity in clinical practice: why, how, and when? Basic Clin Pharmacol Toxicol. 2005; 97: 125-134. doi:10.1111/j.1742-7843.2005.pto-973160.x PubMed
-
(2005)
Basic Clin Pharmacol Toxicol
, vol.97
, pp. 125-134
-
-
Faber, M.S.1
Jetter, A.2
Fuhr, U.3
-
26
-
-
4143107864
-
Lack of pharmacokinetic interactions between cilomilast and theophylline or smoking in healthy volunteers
-
DOI 10.1177/0091270004266488
-
Murdoch RD, Zussman B, Schofield JP, Webber DM. Lack of pharmacokinetic interactions between cilomilast and theophylline or smoking in healthy volunteers. J Clin Pharmacol. 2004; 44: 1046-1053. doi: 10.1177/0091270004266488 PubMed (Pubitemid 39096819)
-
(2004)
Journal of Clinical Pharmacology
, vol.44
, Issue.9
, pp. 1046-1053
-
-
Murdoch, R.D.1
Zussman, B.2
Schofield, J.P.3
Webber, D.M.4
-
27
-
-
77951287116
-
Treatment of chronic obstructive pulmonary disease with roflumilast, a new phosphodiesterase 4 inhibitor
-
doi:10.3109/15412551003758304 PubMed
-
Gross NJ, Giembycz MA, Rennard SI. Treatment of chronic obstructive pulmonary disease with roflumilast, a new phosphodiesterase 4 inhibitor. COPD. 2010; 7: 141-153. doi:10.3109/15412551003758304 PubMed
-
(2010)
COPD
, vol.7
, pp. 141-153
-
-
Gross, N.J.1
Giembycz, M.A.2
Rennard, S.I.3
-
28
-
-
79960180920
-
DAXAS® 500 micrograms film-coated tablets
-
(Merck Sharp & Dohme Ltd, UK) Accessed January 25, 2010
-
Summary of Product Characteristics (UK). DAXAS® 500 micrograms film-coated tablets (Merck Sharp & Dohme Ltd, UK) http://www.medicines.org. uk. Accessed January 25, 2010.
-
Summary of Product Characteristics (UK)
-
-
-
29
-
-
65549103940
-
Effect of repeated dose of erythromycin on the pharmacokinetics of roflumilast and roflumilast N-oxide
-
PubMed
-
Lahu G, Huennemeyer A, Herzog R, McCracken N, Hermann R, Elmlinger M, Zech K. Effect of repeated dose of erythromycin on the pharmacokinetics of roflumilast and roflumilast N-oxide. Int J Clin Pharmacol Ther. 2009; 47: 236-245. PubMed
-
(2009)
Int J Clin Pharmacol Ther
, vol.47
, pp. 236-245
-
-
Lahu, G.1
Huennemeyer, A.2
Herzog, R.3
McCracken, N.4
Hermann, R.5
Elmlinger, M.6
Zech, K.7
-
30
-
-
54049140448
-
Effect of single and repeated doses of ketoconazole on the pharmacokinetics of roflumilast and roflumilast N-oxide
-
doi:10.1177/0091270008321941 PubMed
-
Lahu G, Huennemeyer A, von Richter O, Hermann R, Herzog R, McCracken N, Zech K. Effect of single and repeated doses of ketoconazole on the pharmacokinetics of roflumilast and roflumilast N-oxide. J Clin Pharmacol. 2008; 48: 1339-1349. doi:10.1177/0091270008321941 PubMed
-
(2008)
J Clin Pharmacol
, vol.48
, pp. 1339-1349
-
-
Lahu, G.1
Huennemeyer, A.2
Von Richter, O.3
Hermann, R.4
Herzog, R.5
McCracken, N.6
Zech, K.7
-
31
-
-
33846985306
-
Lack of a pharmacokinetic interaction between steady-state roflumilast and single-dose midazolam in healthy subjects
-
doi:10.1111/j.1365-2125.2006.02762.x PubMed
-
Nassr N, Lahu G, von Richter O, Reutter F, Knoerzer D, Zech K, Erb KA, Schug B, Blume H, Hermann R. Lack of a pharmacokinetic interaction between steady-state roflumilast and single-dose midazolam in healthy subjects. Br J Clin Pharmacol. 2007; 63: 365-370. doi:10.1111/j.1365-2125.2006.02762.x PubMed
-
(2007)
Br J Clin Pharmacol
, vol.63
, pp. 365-370
-
-
Nassr, N.1
Lahu, G.2
Von Richter, O.3
Reutter, F.4
Knoerzer, D.5
Zech, K.6
Erb, K.A.7
Schug, B.8
Blume, H.9
Hermann, R.10
|