Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: the MONtelukast In Chronic Asthma (MONICA) study
J Christian Virchow, Anish Mehta, Li Ljungblad, Harald Mitfessel, MONICA study group, G von Kirchbach, U Lenk, K-U Walther, F Elling, N Reinholz, H Weber, S Wehgartner-Winkler, H Alakmeh, G Bülow, M Werner, N Graubner, T Syriste, R Stein, J Junggeburth, R Neukum, T Paufler, K Lohse, H Martin, W Reimann, S Binnewies, A Stei, B Askar, C Bästlein, B Dürlich, M Esmandar, K Förster, A Fritzsche, R Gebhardt, K Günsberg, J Kampschulte, F Klüppelberg, M Korduan, A Linnhoff, H Lode, D-H Mahlo, H Müller-Pawlowski, O Peters, M Petri, K-P Ruppert, N-K Scheffler, A Scheifler, S Schmidtmann, W Schoppnies, R Schultebraucks, T Schultz, M Schwamborn, S Thalhofer, M Urban, L von Versen, U Westerhausen, S Wiemer, S Timm, I Sari, I Schlösser, W Reier, T Ginko, A Overlack, J Schönen, P-M Stutz, D Kern, M Egg, M Jahn, H Burow, A Demedts, R Andrek, J Hegenbarth, T Mutz, V Grimm-Sachs, H Vehar, T Salloum, F Kässner, G Bourgeois, G Bokelmann, A Forster, K-O Steinmetz, G Wacker, F Talkner, A Reibe, E-J Winkelmann, K-E Maslowski, H-C Blum, B Butsch von der Heydt, J Bickhardt, E Laake, A Markendorf, D Mieth, F Schmidt, J Schwiese, F-J Berger, W Winkels, H Güttler, G Ohlschläger, J Munteanu, C Schilder, B-G Trümper, N Peslis, I Itzigehl, W Luplow, J Aretz, M Bautz, E Chesin, C Keller, B Michels, S Müller, M Weber, H Trötschler, M Schmitt, G Reiner, A Heinze, P Maczek, G Havasi-Jost, D Busch, G Ern, E Eisel, M Kunze, C Laskowitz, U Hengst, C Rudloff, U Heschel, A Drews, E Drews, H-J Wünschmann, H Renz, W Gams, F Feldmeyer, C Kellner, P-U Haase, K Lauerwald, S-P Aries, R Bock, K Christov, A Iwansky, G Klam, D-C Patzer, K Polke, J Sturm, G Wackerbeck, H-P Dirks, B Waberzeck, A Abenhardt, J Hinrichs-Pavlik, P van Bodegom, G Stöckle, A Eilers, T Koumba-Moubikou, P Häberlein, C Stolpe, R Burbach, G Wilmsmann, K Pumpe, B Kroemer, W Pfeifer, R Fischer, D Auge, A Kroker, A Manstein, M Schaeben, O Schmidt, J Wenkow, G Giesemann, A Schareina, S Asten, M Schroers, J Jurga, H Steffen, G Steinkirchner, L Burger, R Deckelmann, G Eckhardt, C Gessner, G Hoheisel, J Winkler, K Littek-Rottmann, V Seiz, M Klenner, H Fleck, R Schmatzler, J Becker, H Freund, C Kreiker, D Kubitscheck, R Luther, T Wiebe, A-K Auracher, R Boos, U Gordt, A Moritz, G Pierro-Löbelenz, J Purgaij, E Träger, C Trainer, H-A Trauth, R Bernhardt, V Jansen, R Dresler, J Kufper, E Baumann, O-J Brückner, F Bullemer, J Feimer, M Kamaterou-Munker, H Kammler-Baumann, C Köhl, A Krieger, F Schmidt, K Storck, W Tzimas, J Weöres, I Walter, T Hagen, A Weihrich, P-J Arens, C Neifer, J Uerscheln, M Dünzel, U Marangone, S Aichinger, H-J Beeck, P Bölcskei, E Gill, D Klopf, V-E Trapp, A Happel, F Kokorsch, T Seefried, N Zangana, U Felgner, A-K Schmidt, W-U Venske, P-G Czerny, R Weil, F Richter, S Ziebuhr, R Bamberg, S Hofmann, H Müller, R Hennig, B Jasch, C Lottner, K-H Zeisler, U Bettig, H Mitfessel, E Beck, A Sahan, V Bergmann, M Hoefer, S Wagner, D Hess, A Deimling, B Volger, H-P Hlawa, A Westphal, H Pöllmann, P Seidel, A Bieberle, B Klöckner, S Schmidt, U Steinhauser, U Botzen, M Jezek, F Richling, C Franke, M Franke, R Jurischka, G Brockhausen, G Pasterkamp, K Klütsch, C Weinz, R Ehmann, M-M Koncz, B Rosenblum, V Tansek, P Ring, E Malik-Kumberg, R Sauer, H Warmuth, U Bloching, Weyhe, W Vorderstrasse, K-D Jasch, D Schuster, J Thomas, G Dunkhase, J Müller, H von Bohlen, R Dichmann, K-H Franz, U Weber, A Ostrowsky, P Kühne, M Raffenberg, J Christian Virchow, Anish Mehta, Li Ljungblad, Harald Mitfessel, MONICA study group, G von Kirchbach, U Lenk, K-U Walther, F Elling, N Reinholz, H Weber, S Wehgartner-Winkler, H Alakmeh, G Bülow, M Werner, N Graubner, T Syriste, R Stein, J Junggeburth, R Neukum, T Paufler, K Lohse, H Martin, W Reimann, S Binnewies, A Stei, B Askar, C Bästlein, B Dürlich, M Esmandar, K Förster, A Fritzsche, R Gebhardt, K Günsberg, J Kampschulte, F Klüppelberg, M Korduan, A Linnhoff, H Lode, D-H Mahlo, H Müller-Pawlowski, O Peters, M Petri, K-P Ruppert, N-K Scheffler, A Scheifler, S Schmidtmann, W Schoppnies, R Schultebraucks, T Schultz, M Schwamborn, S Thalhofer, M Urban, L von Versen, U Westerhausen, S Wiemer, S Timm, I Sari, I Schlösser, W Reier, T Ginko, A Overlack, J Schönen, P-M Stutz, D Kern, M Egg, M Jahn, H Burow, A Demedts, R Andrek, J Hegenbarth, T Mutz, V Grimm-Sachs, H Vehar, T Salloum, F Kässner, G Bourgeois, G Bokelmann, A Forster, K-O Steinmetz, G Wacker, F Talkner, A Reibe, E-J Winkelmann, K-E Maslowski, H-C Blum, B Butsch von der Heydt, J Bickhardt, E Laake, A Markendorf, D Mieth, F Schmidt, J Schwiese, F-J Berger, W Winkels, H Güttler, G Ohlschläger, J Munteanu, C Schilder, B-G Trümper, N Peslis, I Itzigehl, W Luplow, J Aretz, M Bautz, E Chesin, C Keller, B Michels, S Müller, M Weber, H Trötschler, M Schmitt, G Reiner, A Heinze, P Maczek, G Havasi-Jost, D Busch, G Ern, E Eisel, M Kunze, C Laskowitz, U Hengst, C Rudloff, U Heschel, A Drews, E Drews, H-J Wünschmann, H Renz, W Gams, F Feldmeyer, C Kellner, P-U Haase, K Lauerwald, S-P Aries, R Bock, K Christov, A Iwansky, G Klam, D-C Patzer, K Polke, J Sturm, G Wackerbeck, H-P Dirks, B Waberzeck, A Abenhardt, J Hinrichs-Pavlik, P van Bodegom, G Stöckle, A Eilers, T Koumba-Moubikou, P Häberlein, C Stolpe, R Burbach, G Wilmsmann, K Pumpe, B Kroemer, W Pfeifer, R Fischer, D Auge, A Kroker, A Manstein, M Schaeben, O Schmidt, J Wenkow, G Giesemann, A Schareina, S Asten, M Schroers, J Jurga, H Steffen, G Steinkirchner, L Burger, R Deckelmann, G Eckhardt, C Gessner, G Hoheisel, J Winkler, K Littek-Rottmann, V Seiz, M Klenner, H Fleck, R Schmatzler, J Becker, H Freund, C Kreiker, D Kubitscheck, R Luther, T Wiebe, A-K Auracher, R Boos, U Gordt, A Moritz, G Pierro-Löbelenz, J Purgaij, E Träger, C Trainer, H-A Trauth, R Bernhardt, V Jansen, R Dresler, J Kufper, E Baumann, O-J Brückner, F Bullemer, J Feimer, M Kamaterou-Munker, H Kammler-Baumann, C Köhl, A Krieger, F Schmidt, K Storck, W Tzimas, J Weöres, I Walter, T Hagen, A Weihrich, P-J Arens, C Neifer, J Uerscheln, M Dünzel, U Marangone, S Aichinger, H-J Beeck, P Bölcskei, E Gill, D Klopf, V-E Trapp, A Happel, F Kokorsch, T Seefried, N Zangana, U Felgner, A-K Schmidt, W-U Venske, P-G Czerny, R Weil, F Richter, S Ziebuhr, R Bamberg, S Hofmann, H Müller, R Hennig, B Jasch, C Lottner, K-H Zeisler, U Bettig, H Mitfessel, E Beck, A Sahan, V Bergmann, M Hoefer, S Wagner, D Hess, A Deimling, B Volger, H-P Hlawa, A Westphal, H Pöllmann, P Seidel, A Bieberle, B Klöckner, S Schmidt, U Steinhauser, U Botzen, M Jezek, F Richling, C Franke, M Franke, R Jurischka, G Brockhausen, G Pasterkamp, K Klütsch, C Weinz, R Ehmann, M-M Koncz, B Rosenblum, V Tansek, P Ring, E Malik-Kumberg, R Sauer, H Warmuth, U Bloching, Weyhe, W Vorderstrasse, K-D Jasch, D Schuster, J Thomas, G Dunkhase, J Müller, H von Bohlen, R Dichmann, K-H Franz, U Weber, A Ostrowsky, P Kühne, M Raffenberg
Abstract
Bronchial asthma often remains uncontrolled despite treatment with inhaled corticosteroids (ICS), long-acting beta(2)-agonists (LABA) or both, necessitating additional treatment. Patients >or=18 years (n=1681) with mild-to-moderate asthma received oral montelukast 10mg added to ICS or ICS+LABAs, and were followed for 6 months in a prospective, open-label observational study. The primary endpoint was change in Asthma Control Test (ACT) score. Secondary endpoints included mini-Asthma Quality-of-Life Questionnaire (mini-AQLQ) and FEV(1)/PEF. Mean ACT scores improved from 14.6+/-4.6 (baseline) to 19.4+/-4.4 (month 6; p<0.0001). Using ACT score categories, the percentage of patients with uncontrolled (57.5%) or poorly controlled (25.0%) asthma at baseline decreased at month 6 (17.6 and 21.7%, respectively); the percentage of patients with well controlled (13.9%) or completely controlled (1.2%) asthma at baseline increased at month 6 (47.5 and 11.4%, respectively). The mini-AQLQ score (mean+/-SD) improved from 4.0+/-1.1 to 5.3+/-1.1 (p<0.0001); FEV(1) increased from 2.46+/-0.89 to 2.60+/-0.92L (p<0.0001). Treatment with montelukast was generally well tolerated. In patients insufficiently controlled with ICS or ICS+LABAs, daily add-on montelukast improved both asthma control and asthma-related quality of life. Clinicaltrials.gov registry number NCT00802789.
Source: PubMed