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1. Assessment of physical functioning and handling of tiotropium/olodaterol Respimat® in patients with COPD in a real-world clinical setting

Author

Steinmetz KO, Abenhardt B, Pabst S, Hänsel M, Kondla A, Bayer V, and Buhl R

Subjects
Tiotropium, olodaterol, chronic obstructive pulmonary disease, physical activity, non-interventional study, Diseases of the respiratory system, RC705-779
Abstract

Karl-Otto Steinmetz,1 Birgit Abenhardt,2 Stefan Pabst,3 Michaela Hänsel,4 Anke Kondla,5 Valentina Bayer,6 Roland Buhl71LungCenter Darmstadt, Darmstadt, Germany; 2Pulmonary Practice, Heidelberg, Germany; 3Lung Center, Bonn-Duisdorf, Germany; 4TA Respiratory/Biosimilars, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 5Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 7Pulmonary Department, Johannes Gutenberg University Hospital Mainz, Mainz, GermanyBackground: Patients with chronic obstructive pulmonary disease (COPD) show signs of reduced physical activity from the early stages of the disease, impacting morbidity and mortality. Data suggest treatment with tiotropium, a long-acting muscarinic antagonist, and olodaterol, a long-acting ß2-agonist (LABA), as monotherapies and in combination, increases exercise capacity. This study assessed the effects of fixed-dose tiotropium/olodaterol (delivered via Respimat®,) on physical function in Global Initiative for Chronic Obstructive Lung Disease A–D patients requiring long-acting dual bronchodilation treatment in a real-world setting.Methods: This open-label, single arm, noninterventional study measured changes in physical function in COPD patients treated with tiotropium/olodaterol 5/5 μg for approximately 6 weeks (between Visit 1 [baseline] and Visit 2). Primary end point was therapeutic success, defined as a minimum 10-point increase in Physical Functioning Questionnaire (PF-10) score. Secondary end points included change in PF-10 from Visit 1 to Visit 2, the patient’s general condition (measured by Physician’s Global Evaluation score) at Visit 1 and Visit 2, and patient satisfaction with treatment delivered via the Respimat®, device (assessed by Patient Satisfaction Questionnaire) at study end.Results: Therapeutic success was observed in 51.5% of 1578 patients (95% confidence interval [CI] 49.0, 54.0) after approximately 6 weeks of treatment with tiotropium/olodaterol. Mean change in PF-10 score between Visit 1 and Visit 2 was 11.6 points (95% CI 10.7, 12.6). Patient general condition improved as indicated by a general improvement in scores between visits. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment (82.5%), inhalation (87.5%), and handling of Respimat®, (85.2%). One percent of patients reported an investigator-defined drug-related adverse events (AE).Conclusion: Tiotropium/olodaterol treatment improved physical functioning in COPD patients. An associated increase in patient general condition was observed. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment, inhaling, and handling of the Respimat®, device. No unexpected drug-related AE occurred.Keywords: tiotropium, olodaterol, chronic obstructive pulmonary disease, physical activity, noninterventional study

Published
2019

2. The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: effectiveness of early intervention with budesonide in mild persistent asthma

Author

BUSSE WW, PEDERSEN S, PAUWELS RA, TAN WC, CHEN YZ, LAMM CJ, Eckmayr J, Riedler J, Wurzinger G, Ott G, Zarkovic J, Schulheim A, Götz M, Schinko H, Thomüller I, de Backer W, van Bever H, Verleden G, de Boeck C, Aumann J, Vincken W, Dab I, de Vuyst P, de Jonghe M, Casimir G, Joos G, de Baets F, Bogaerts Y, Halloy JL, Bartsch P, Thiriaux J, Pohunek P, Rybníćek O, Skopková O, Pavelková L, Broź P, Ohnutková E, Novotná B, Baly J, Krćmová I, Kuralová Z, Koćí T, Honomichlová H, Kaśák V, Panzner P, Vondra V, Némećková J, Seberová E, Sykora T, Vít P, Turzíková J, Sörensen T, Neldam S, Peter J, Kludt J, Hansen UB, Knudsen T, Schultz PJ, Rost D, Jensen F, Kinnula V, Saarelainen P, Eho Remes M, Valovirta E, Venho KK, Kokko E, Järvinen M, Toljamo T, Taivainen A, Kava T, Herrala J, Kuusela AL, Nordgren P, Syvänen P, Godard P, Rufin P, Anton M, Aubert JP, Grosclaude M, Brambilla C, Archaud P, Racineux JL, Muir JF, Albertini M, Le Roux P, Simmons A, Bartuschka B, von Berg A, Bergmann V, Berns J, Bisping Arnold A, Blum HC, Garanin G, Brückner OJ, Burbach P, Sudhoff H, Feldmann M, Schmoller T, Wozny HW, Galaske R, Huptas M, Kaecke J, Köcher V, Laule Peschel M, Lohr E, Goldberg J, Drescher T, Reeh W, Rabe U, Rehn L, Scheffler NK, Steinmetz KO, Stutz PM, Weber HH, Uhde C, Ullner R, Vehar H, Krohn EU, Orosz M, Devai A, Uhereczky G, Rajkay K, Gönczi F, Györi E, Dobra G, Puha K, Sztancsik Z, Gömöri K, Dolinay T, Bittera I, Palinkasi S, Cseke Z, Bisits M, Bjämer D, Holme JI, Langhammer A, Hunstad K, Holmboe JH, Grangård E, Solberg DA, Grönneröd TA, Salkowitsch MB, Oymar K, Iversen K, Szczeklik A, Chyrek Borowska S, Mincewicz G, Malaczynska T, Latos T, Obtulowicz K, Emeryk A, Gorski P, Nowak D, Szmidt M, Alkiewicz J, Ziolo G, Spychalski L, Chmielewska Szewczyk D, Nowacka K, Pirozynski M, Prokurat H, Boznanski A, Malolepszy J, Rogala E, Kozielski J, Eriksson UL, Wahlestedt H, Selberg M, Larsson R, Rignér K, Alm B, Aronsson M, Winnergård I, Lagerwall M, Martinsons U, Berlin L, Rydberg B, Weston D, Johnson ME, Barrett C, Siafakas N, Mantzourani E, Orphanidou D, Trakopoulos G, Tzannes S, Kotsovoulou V, Dimadi M, Amfilochiou A, Priftis K, Papageorgiou Saxoni F, Christaki P, Tsanakas I, Paraskevi M, Bousmoukilia S, Spiropoulos K, Anthrakopoulos M, Roussos C, Bentur Alkouby L, Heimer D, Tal A, Horowitz I, Soferman R, Katz Y, Stav D, Weiler Z, Bibi H, Rottem M, Mandelberg A, Geller C, Roizin H, Weiler Ravell D, Kramer MR, Schwartz Y, Rossi A, Foresi A, Giuntini C, Bisetti A, Scoditti S, Tranfa C, Zacchello F, Giovannini M, Boner A, Fabbri LM, Girbino G, Barberio G, Cacciari E, Montefort S, Parascandalo R, Pato R, de Lourdes Chieira M, Moreira C, Chieira DS, Brito U, Borges FD, Marques AC, Figueiredo MM, Dias F, de Almeida AB, Cesar Ramos J, Valente MJ, Pereira JD, Nunes C, Riberio MF, Marques A, Carvalho MQ, de Azevedo MV, de Almeida AR, Pinto JA, Matos Mde F, Afonso A, Dos Santos JM, Fernandez CV, Agustin IC, Bejarano JM, Santos AA, Font ET, Huet EH, Lorente TL, Pujol MM, Munoz AP, Aineto PS, Forns SB, Areu JB, Casan P, Garcia JM, Rodriguez AV, Segura PA, Gil RS, Ciscar CP, Garcia JF, Jimenez TV, Gonzalez JI, Andres FQ, Bueno TA, Baticon CO, Miguel CR, Garcia FD, Hernando HV, Vina AL, Matia RA, Cumplido AS, Andueza MC, Cabra MS, Navarro PL, Rodriguez FA, Li JH, Landry D, O'Keefe D, Muram BF, Conter HS, Tweel D, Peters SD, Adelglass J, Baker JW, Berger WE, Bernstein DI, Blake KV, Amelong P, Casale TB, Charous BL, Chervinsky P, Condemi JJ, Cook D, Creticos PS, de Graff AC Jr, Smith T, Ellis MH, Grossman J, Halverson PC, Galant S, Hollingsworth H, Jackson C, Jacobs RL, Welch M, Kraemer MJ, Leflein J, Lemanske RF, Liebhaber MI, Lockey R, Kelly B, Mendelson L, Nayak A, Pearlman DS, Ruff M, Schwartz B, Scott MB, Shapiro GG, Silk HJ, Skoner DP, Stoloff S, Swamy KN, Atkins FM, Szefler SJ, Vandewalker M, Wald J, Weinstein SF, Wong DA, Wu F, Goldstein S, Murthy KC, Dolmann A, Gene R, Casas JC, Piovano C, Segal E, Balanzat AM, Taborda J, Truganti A, Teper A, Garrood J, Patel MJ, Hogan C, Russel G, Zhu YJ, Cao L, Liu SY, Miao JZ, Ding DJ, Yao WZ, Liu YN, Chen P, Kong SQ, Pang L, Sun B, Li ZM, Li GS, Chen PL, Zhu Q, Zhang TX, Wang XH, Wei S, Deng WW, Zhou X, Ji YY, Luo WT, Li Q, Zhu HR, Sheng JY, Ma JY, Zhang DP, Ji CZ, Xia XR, Zhang ZY, Yin KS, Yiang J, Li Y, Tang PW, Liu FG, Wang HP, Zhong NS, Rong ZS, Tang YC, Lin CY, Liu JS, Liu HZ, Cai DM, Yang JC, Ma QF, Mangunnegoro H, Wijono CA, Tobing NH, Rahajoe NN, Sugito, Surjanto E, Hisyam B, Alsagaff H, Santosa G, Kim YY, Park CS, Kim MK, Cho YJ, Choi DC, Jee YK, Mohan J, Yogeswery S, Wong SL, Kuan GL, Koh CT, Quah BS, de Bruyne J, Liam CK, Avila MM, Cuevas F, Chavaje N, Topete LA, Badillo I, Ponce M, Merida JC, Espinosa AG, Ledezma JM, García JA, Morales GG, Gomez JM, Martinez FJ, Ramos JE, Dorantes JR, Gonzalez CC, Vera JG, Bayardo RG, Melendez AP, Loyola CB, Suárez MA, de Guia T, Balgos A, Bautista N, Realiza T, Diaz D, Yu C, Mendoza Wi JA, Juaneza R, Bigornia R, Mansukhani P, Cacanindin DN, Wah LB, Hon YK, Yau OY, Moh CO, Tang WY, Dippenaar YD, Kirsten DL, Maraschin EF, Ossip MS, Visser SS, Mouton WL, Mercer M, Cassim KM, Macleod AH, Bateman ED, Leaver R, Morison A, Nel H, von Delft KH, Vermeulen JH, Weinberg EG, Lund RJ, Weber HC, Kuo SH, Kuo HP, Wang JL, Hsiue TR, Wang JH, Ching CD, Vangveeravong M, Pothiratana C, Trakultivakorn M, Kongpanichkul A, Thamanavat B, Fuangtong R, Suntornlohanakul S, Youngchaiyud P, Teeratakulpisarn J, Boonsawat W, Viriyachaiyo V, Direkwattanachai C, Visitsunthorn N., MIRAGLIA DEL GIUDICE, Michele, Busse, Ww, Pedersen, S, Pauwels, Ra, Tan, Wc, Chen, Yz, Lamm, Cj, Eckmayr, J, Riedler, J, Wurzinger, G, Ott, G, Zarkovic, J, Schulheim, A, Götz, M, Schinko, H, Thomüller, I, de Backer, W, van Bever, H, Verleden, G, de Boeck, C, Aumann, J, Vincken, W, Dab, I, de Vuyst, P, de Jonghe, M, Casimir, G, Joos, G, de Baets, F, Bogaerts, Y, Halloy, Jl, Bartsch, P, Thiriaux, J, Pohunek, P, Rybníćek, O, Skopková, O, Pavelková, L, Broź, P, Ohnutková, E, Novotná, B, Baly, J, Krćmová, I, Kuralová, Z, Koćí, T, Honomichlová, H, Kaśák, V, Panzner, P, Vondra, V, Némećková, J, Seberová, E, Sykora, T, Vít, P, Turzíková, J, Sörensen, T, Neldam, S, Peter, J, Kludt, J, Hansen, Ub, Knudsen, T, Schultz, Pj, Rost, D, Jensen, F, Kinnula, V, Saarelainen, P, Eho Remes, M, Valovirta, E, Venho, Kk, Kokko, E, Järvinen, M, Toljamo, T, Taivainen, A, Kava, T, Herrala, J, Kuusela, Al, Nordgren, P, Syvänen, P, Godard, P, Rufin, P, Anton, M, Aubert, Jp, Grosclaude, M, Brambilla, C, Archaud, P, Racineux, Jl, Muir, Jf, Albertini, M, Le Roux, P, Simmons, A, Bartuschka, B, von Berg, A, Bergmann, V, Berns, J, Bisping Arnold, A, Blum, Hc, Garanin, G, Brückner, Oj, Burbach, P, Sudhoff, H, Feldmann, M, Schmoller, T, Wozny, Hw, Galaske, R, Huptas, M, Kaecke, J, Köcher, V, Laule Peschel, M, Lohr, E, Goldberg, J, Drescher, T, Reeh, W, Rabe, U, Rehn, L, Scheffler, Nk, Steinmetz, Ko, Stutz, Pm, Weber, Hh, Uhde, C, Ullner, R, Vehar, H, Krohn, Eu, Orosz, M, Devai, A, Uhereczky, G, Rajkay, K, Gönczi, F, Györi, E, Dobra, G, Puha, K, Sztancsik, Z, Gömöri, K, Dolinay, T, Bittera, I, Palinkasi, S, Cseke, Z, Bisits, M, Bjämer, D, Holme, Ji, Langhammer, A, Hunstad, K, Holmboe, Jh, Grangård, E, Solberg, Da, Grönneröd, Ta, Salkowitsch, Mb, Oymar, K, Iversen, K, Szczeklik, A, Chyrek Borowska, S, Mincewicz, G, Malaczynska, T, Latos, T, Obtulowicz, K, Emeryk, A, Gorski, P, Nowak, D, Szmidt, M, Alkiewicz, J, Ziolo, G, Spychalski, L, Chmielewska Szewczyk, D, Nowacka, K, Pirozynski, M, Prokurat, H, Boznanski, A, Malolepszy, J, Rogala, E, Kozielski, J, Eriksson, Ul, Wahlestedt, H, Selberg, M, Larsson, R, Rignér, K, Alm, B, Aronsson, M, Winnergård, I, Lagerwall, M, Martinsons, U, Berlin, L, Rydberg, B, Weston, D, Johnson, Me, Barrett, C, Siafakas, N, Mantzourani, E, Orphanidou, D, Trakopoulos, G, Tzannes, S, Kotsovoulou, V, Dimadi, M, Amfilochiou, A, Priftis, K, Papageorgiou Saxoni, F, Christaki, P, Tsanakas, I, Paraskevi, M, Bousmoukilia, S, Spiropoulos, K, Anthrakopoulos, M, Roussos, C, Bentur Alkouby, L, Heimer, D, Tal, A, Horowitz, I, Soferman, R, Katz, Y, Stav, D, Weiler, Z, Bibi, H, Rottem, M, Mandelberg, A, Geller, C, Roizin, H, Weiler Ravell, D, Kramer, Mr, Schwartz, Y, Rossi, A, Foresi, A, Giuntini, C, Bisetti, A, Scoditti, S, Tranfa, C, Zacchello, F, Giovannini, M, Boner, A, MIRAGLIA DEL GIUDICE, Michele, Fabbri, Lm, Girbino, G, Barberio, G, Cacciari, E, Montefort, S, Parascandalo, R, Pato, R, de Lourdes Chieira, M, Moreira, C, Chieira, D, Brito, U, Borges, Fd, Marques, Ac, Figueiredo, Mm, Dias, F, de Almeida, Ab, Cesar Ramos, J, Valente, Mj, Pereira, Jd, Nunes, C, Riberio, Mf, Marques, A, Carvalho, Mq, de Azevedo, Mv, de Almeida, Ar, Pinto, Ja, Matos Mde, F, Afonso, A, Dos Santos, Jm, Fernandez, Cv, Agustin, Ic, Bejarano, Jm, Santos, Aa, Font, Et, Huet, Eh, Lorente, Tl, Pujol, Mm, Munoz, Ap, Aineto, P, Forns, Sb, Areu, Jb, Casan, P, Garcia, Jm, Rodriguez, Av, Segura, Pa, Gil, R, Ciscar, Cp, Garcia, Jf, Jimenez, Tv, Gonzalez, Ji, Andres, Fq, Bueno, Ta, Baticon, Co, Miguel, Cr, Garcia, Fd, Hernando, Hv, Vina, Al, Matia, Ra, Cumplido, A, Andueza, Mc, Cabra, M, Navarro, Pl, Rodriguez, Fa, Li, Jh, Landry, D, O'Keefe, D, Muram, Bf, Conter, H, Tweel, D, Peters, Sd, Adelglass, J, Baker, Jw, Berger, We, Bernstein, Di, Blake, Kv, Amelong, P, Casale, Tb, Charous, Bl, Chervinsky, P, Condemi, Jj, Cook, D, Creticos, P, de Graff AC, Jr, Smith, T, Ellis, Mh, Grossman, J, Halverson, Pc, Galant, S, Hollingsworth, H, Jackson, C, Jacobs, Rl, Welch, M, Kraemer, Mj, Leflein, J, Lemanske, Rf, Liebhaber, Mi, Lockey, R, Kelly, B, Mendelson, L, Nayak, A, Pearlman, D, Ruff, M, Schwartz, B, Scott, Mb, Shapiro, Gg, Silk, Hj, Skoner, Dp, Stoloff, S, Swamy, Kn, Atkins, Fm, Szefler, Sj, Vandewalker, M, Wald, J, Weinstein, Sf, Wong, Da, Wu, F, Goldstein, S, Murthy, Kc, Dolmann, A, Gene, R, Casas, Jc, Piovano, C, Segal, E, Balanzat, Am, Taborda, J, Truganti, A, Teper, A, Garrood, J, Patel, Mj, Hogan, C, Russel, G, Zhu, Yj, Cao, L, Liu, Sy, Miao, Jz, Ding, Dj, Yao, Wz, Liu, Yn, Chen, P, Kong, Sq, Pang, L, Sun, B, Li, Zm, Li, G, Chen, Pl, Zhu, Q, Zhang, Tx, Wang, Xh, Wei, S, Deng, Ww, Zhou, X, Ji, Yy, Luo, Wt, Li, Q, Zhu, Hr, Sheng, Jy, Ma, Jy, Zhang, Dp, Ji, Cz, Xia, Xr, Zhang, Zy, Yin, K, Yiang, J, Li, Y, Tang, Pw, Liu, Fg, Wang, Hp, Zhong, N, Rong, Z, Tang, Yc, Lin, Cy, Liu, J, Liu, Hz, Cai, Dm, Yang, Jc, Ma, Qf, Mangunnegoro, H, Wijono, Ca, Tobing, Nh, Rahajoe, Nn, Sugito, Surjanto, E, Hisyam, B, Alsagaff, H, Santosa, G, Kim, Yy, Park, C, Kim, Mk, Cho, Yj, Choi, Dc, Jee, Yk, Mohan, J, Yogeswery, S, Wong, Sl, Kuan, Gl, Koh, Ct, Quah, B, de Bruyne, J, Liam, Ck, Avila, Mm, Cuevas, F, Chavaje, N, Topete, La, Badillo, I, Ponce, M, Merida, Jc, Espinosa, Ag, Ledezma, Jm, García, Ja, Morales, Gg, Gomez, Jm, Martinez, Fj, Ramos, Je, Dorantes, Jr, Gonzalez, Cc, Vera, Jg, Bayardo, Rg, Melendez, Ap, Loyola, Cb, Suárez, Ma, de Guia, T, Balgos, A, Bautista, N, Realiza, T, Diaz, D, Yu, C, Mendoza Wi, Ja, Juaneza, R, Bigornia, R, Mansukhani, P, Cacanindin, Dn, Wah, Lb, Hon, Yk, Yau, Oy, Moh, Co, Tang, Wy, Dippenaar, Yd, Kirsten, Dl, Maraschin, Ef, Ossip, M, Visser, S, Mouton, Wl, Mercer, M, Cassim, Km, Macleod, Ah, Bateman, Ed, Leaver, R, Morison, A, Nel, H, von Delft, Kh, Vermeulen, Jh, Weinberg, Eg, Lund, Rj, Weber, Hc, Kuo, Sh, Kuo, Hp, Wang, Jl, Hsiue, Tr, Wang, Jh, Ching, Cd, Vangveeravong, M, Pothiratana, C, Trakultivakorn, M, Kongpanichkul, A, Thamanavat, B, Fuangtong, R, Suntornlohanakul, S, Youngchaiyud, P, Teeratakulpisarn, J, Boonsawat, W, Viriyachaiyo, V, Direkwattanachai, C, and Visitsunthorn, N.

Published
2008

3. Assessment of physical functioning and handling of tiotropium/olodaterol Respimat ® in patients with COPD in a real-world clinical setting.

Author

Steinmetz KO, Abenhardt B, Pabst S, Hänsel M, Kondla A, Bayer V, and Buhl R

Subjects
Administration, Inhalation, Adrenergic beta-2 Receptor Agonists adverse effects, Aged, Benzoxazines adverse effects, Bronchodilator Agents adverse effects, Drug Combinations, Female, Humans, Lung physiopathology, Male, Middle Aged, Muscarinic Antagonists adverse effects, Nebulizers and Vaporizers, Patient Satisfaction, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive physiopathology, Recovery of Function, Time Factors, Tiotropium Bromide adverse effects, Treatment Outcome, Adrenergic beta-2 Receptor Agonists administration & dosage, Benzoxazines administration & dosage, Bronchodilator Agents administration & dosage, Exercise Tolerance drug effects, Lung drug effects, Muscarinic Antagonists administration & dosage, Pulmonary Disease, Chronic Obstructive drug therapy, Tiotropium Bromide administration & dosage
Abstract

Background: Patients with chronic obstructive pulmonary disease (COPD) show signs of reduced physical activity from the early stages of the disease, impacting morbidity and mortality. Data suggest treatment with tiotropium, a long-acting muscarinic antagonist, and olodaterol, a long-acting ß 2 -agonist (LABA), as monotherapies and in combination, increases exercise capacity. This study assessed the effects of fixed-dose tiotropium/olodaterol (delivered via Respimat ® ) on physical function in Global Initiative for Chronic Obstructive Lung Disease A-D patients requiring long-acting dual bronchodilation treatment in a real-world setting., Methods: This open-label, single arm, noninterventional study measured changes in physical function in COPD patients treated with tiotropium/olodaterol 5/5 μg for approximately 6 weeks (between Visit 1 [baseline] and Visit 2). Primary end point was therapeutic success, defined as a minimum 10-point increase in Physical Functioning Questionnaire (PF-10) score. Secondary end points included change in PF-10 from Visit 1 to Visit 2, the patient's general condition (measured by Physician's Global Evaluation score) at Visit 1 and Visit 2, and patient satisfaction with treatment delivered via the Respimat ® device (assessed by Patient Satisfaction Questionnaire) at study end., Results: Therapeutic success was observed in 51.5% of 1578 patients (95% confidence interval [CI] 49.0, 54.0) after approximately 6 weeks of treatment with tiotropium/olodaterol. Mean change in PF-10 score between Visit 1 and Visit 2 was 11.6 points (95% CI 10.7, 12.6). Patient general condition improved as indicated by a general improvement in scores between visits. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment (82.5%), inhalation (87.5%), and handling of Respimat ® (85.2%). One percent of patients reported an investigator-defined drug-related adverse events (AE)., Conclusion: Tiotropium/olodaterol treatment improved physical functioning in COPD patients. An associated increase in patient general condition was observed. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment, inhaling, and handling of the Respimat ® device. No unexpected drug-related AE occurred., Competing Interests: RB received grants and personal fees from Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Roche. He also received personal fees from AstraZeneca, Chiesi, Cipla and Teva, outside the submitted work. SP was an investigator in the submitted work. AK and VB are employees of Boehringer Ingelheim. MH was an employee of Boehringer Ingelheim at the time of the submitted work and is now an employee of CSL Behring GmbH. The authors report no other conflicts of interest in this work.

Published
2019
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4. Salmeterol/fluticasone propionate (50/500 microg) in combination in a Diskus inhaler (Seretide) is effective and safe in the treatment of steroid-dependent asthma.

Author

Aubier M, Pieters WR, Schlösser NJ, and Steinmetz KO

Subjects
Administration, Inhalation, Administration, Topical, Adolescent, Adrenergic beta-Agonists adverse effects, Adult, Aged, Albuterol administration & dosage, Albuterol adverse effects, Androstadienes adverse effects, Anti-Asthmatic Agents adverse effects, Anti-Inflammatory Agents adverse effects, Asthma physiopathology, Bronchodilator Agents adverse effects, Child, Double-Blind Method, Drug Combinations, Drug Therapy, Combination, Female, Fluticasone, Forced Expiratory Volume, Glucocorticoids, Humans, Male, Middle Aged, Nebulizers and Vaporizers, Peak Expiratory Flow Rate, Salmeterol Xinafoate, Adrenergic beta-Agonists administration & dosage, Albuterol analogs & derivatives, Androstadienes administration & dosage, Anti-Asthmatic Agents administration & dosage, Anti-Inflammatory Agents administration & dosage, Asthma drug therapy, Bronchodilator Agents administration & dosage
Abstract

This multicentre double-blind, double-dummy study compared the safety and efficacy of a new combination Diskus inhaler containing both salmeterol 50 microg and fluticasone propionate 500 microg (Seretide, GlaxoWellcome, France) with the same doses of the two drugs delivered via separate Diskus inhalers and with the same dose of fluticasone propionate alone. Patients were eligible for study entry if they had received an inhaled corticosteroid continuously for 12 weeks prior to run-in, and had received treatment with beclomethasone dipropionate or budesonide 1500-2000 microg day(-1) or fluticasone propionate 750-1000 microg day(-1) for at least 4 weeks prior to run-in. In total, 503 patients receiving inhaled corticosteroids were randomized to 28 weeks' treatment with either salmeterol/fluticasone propionate (50/500 microg) via a single Diskus inhaler (combination) and placebo, or salmeterol 50 microg and fluticasone propionate 500 microg administered via separate Diskus inhalers (concurrent), or fluticasone propionate 500 microg and placebo. All treatments were administered twice daily, mean morning peak expiratory flow rate (PEFR) and asthma symptoms were measured for the first 12 weeks and safety data were collected throughout the 28-week study. Over weeks 1 to 12, improvement in adjusted mean morning PEFR was 35 and 33 l min(-1), respectively, in the combination and concurrent therapy treatment groups (12 and 10% increase from baseline, respectively). The mean difference between treatments was -3 l min(-1) (90% confidence interval -10.4 l min(-1)) which was within the criteria for clinical equivalence. However, the combination therapy was statistically significantly superior to fluticasone propionate alone for mean morning PEFR (P<0.001) and other measures of lung function, whilst clinical equivalence of the combination and concurrent therapies was observed. All three treatments were well tolerated. In addition, there were no differences between the three treatments in either the c.hange in serum cortisol or urinary cortisol concentrations, which, for each treatment group, were no significantly different from baseline at the end of the treatment period. Thus, the combination of salmeterol and fluticasone propionate in a single inhaler is as well tolerated and effective in achieving asthma control in steroid-dependent patients as the separate administration of the two drugs, and both combination and concurrent therapy are superior to administration of the same dose of corticosteroid alone.

Published
1999
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5. Cost effectiveness of fluticasone and budesonide in patients with moderate asthma.

Author

Steinmetz KO, Volmer T, Trautmann M, and Kielhorn A

Abstract

Objective: The objective of this study was to assess the relative cost effectiveness of fluticasone via metered dose inhaler and budesonide via Turbuhaler((R)) in corticosteroid-naive patients with moderate asthma from a third-party payer perspective (German Sickness Funds)., Patients and Methods: A retrospective economic assessment of direct medication costs of treatment was performed on data from a prospective, randomised, parallel group, 6-week clinical trial. 457 corticosteroid-naive patients between the ages of 18 and 70 years with moderate asthma were included in the intention-to-treat analysis., Results: The fluticasone group had a higher proportion of successfully treated patients (those with a peak expiratory flow rate improvement of >/=10%) [47 vs 42%], a higher average proportion of symptom-free days (40 vs 34%) and lower direct healthcare costs [1997 Deutschmarks (DM)] per day (DM4.23 vs DM5.19) than the budesonide group. Therefore, the daily costs per successfully treated patient (DM9.00 vs DM12.36) and the cost per symptom-free day (DM10.58 vs DM15.26) were both lower with fluticasone than with budesonide. Sensitivity analysis demonstrated that these results were relatively robust over a wide range of plausible assumptions., Conclusion: These results showed that from the perspective of a third-party payer, fluticasone was more cost effective than budesonide over the 6-week study period.

Published
1998
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