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4. Proceedings of the 2017 WAO Symposium on Hot Topics in Allergy: Pediatric & Regulatory Aspects: Rome, Italy/Vatican City. 27-29 April 2017

Author

Traina G, Valluzzi RL, Fierro V, Riccardi C, Artesani MC, De Vuono A, Fiocchi A, Martelli AG, Ríos LA, Alcocer CR, Navarrete E, Del Rio Navarro BE, Gonzalez V, Velasco B, Perez Aviles HJ, Fernandez RJ, Pozo FC, Farhan AJ, Arshad H, Hussain A, Sharikadze O, Okhotnikova O, Alcover J, Rodríguez Rius D, Pineda F, Dalal I, Weinbrand-Goichberg J, Benor S, Rottem M, Kivity S, Sato S, Yanagida N, Ebisawa M, Umanets T, Antipkin Y, Barzylovich V, Lapshyn V, Umanets M, Yuriev S, Rodriguez D, Bekir S, Pincock T, Vieira Hernandez A, Capriles Hulett A, Sánchez Borges M, Fabiano F, Albarran C, Goyal R, Gupta S, Gaurav G, Luskin AT, Griffin NM, Wagelie-Steffen A, Trzaskoma BL, Limb SL, Busse WW, Zeiger RS, Gonzalez-Reyes E, Casale TB, Chipps BE, Sugizaki C, Goto F, Yamaide A, Mitsunaga K, Tomiita M, Hoshioka A, Shimojo N, Pop LL, Ciuca IM, Tamas L, Lazarescu M, Pienar C, Yamaide F, Fikri B, Sato H, Okishima N, Kobayashi M, Takai M, Nishigata K, Yoda R, Oana YT, Kajiwara C, Shimodaira M, Suzuki T, Iizawa H, Kamijo K, Karmakar B, Bhattacharya SG, Blohlávková S, Kopelentová E, Víšek P, Štádler J, Šetinová I, Novobílská J, Lundelin K, Salminen S, Isolauri E, Pitt T, Flanders T, Peñalver M, Martínez P, Lluch-Canut T, Malet A, Nam YH, Jin HJ, Lee SK, Kulalert P, Sritipsukho P, Pathumanond J, Baynova K, Labella M, De Aramburu T, Prados M, Haanpää L, Aarnio J, Nermes M, Af Ursin P, Kaljonen A, Bala N, Bhagwat K, Hindley J, Chapman M, Baalasubramanian S, Besednjak-Kocijancic L, SenGupta K, Antonova E, Kong AM, Iqbal A, Teague WG, Ortiz B, Paknis B, Rosen K, Szefler S, Alblooshi A, Al-Hammadi S, Vega A, Gutiérrez-Rivas R, Alonso AM, Beitia JM, Belén Mateo M, Cárdenas R, García-Domínguez JJ, Pitchon Dos Reis R, Gonçalves Alvim C, Andrade C, Reis A, Ribeiro H, Panaitescu Bunu C, Marusciac L, Paralescu S, Tamas P, Martí Guadaño E, Escobar Bolaños C, Martí José N, Pau Casanovas P, Biarnés Rib G, Castells M, de Vicente Jiménez T, Mennini M, De Angelis P, Rea F, Malamisura M, Tambucci R, Dall'Oglio L, Del Chierico F, Napolitano T, Reddel S, Vernocchi P, D'Ambrosio A, Putignani L, Dahdah L, Banzato C, Plaza-Martín AM, Bosque García M, Íbero M, Mazzina O, Marzano V, Pecora V, Koch P, Valentini D, Santamaria F, Mukherjee A, Kandhare A, and Bodhankar S

Published
2017

5. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone

Author

Stempel, Da, Raphiou, Ih, Kral, Km, Yeakey, Am, Emmett, Ah, Prazma, Cm, Buaron, Ks, Pascoe, Sj, Austri, Investigators, Altieri, Hh, Antuni, Jd, Bergna, Ma, Cuadrado, Ja, De Gennaro MS, Fazio Lizandrelo CL, Gattolin, G, Gosn, Am, Larrateguy, Ld, Marcipar, Am, Maspero, Jf, Medina, Iv, Perez Chada RD, Silva, D, Victorio, Cf, Bardin, Pg, Carroll, Pa, Clements, Bs, Dore, Nd, Robinson, Pd, Fitzgerald, Da, Robinson, Pj, Russo, Ma, Sajkov, D, Thomas, Ps, Upham, Jw, Forstner, B, Kaik, G, Koeberl, Gh, Studnicka, M, Wallner, G, Balthazar, Y, Bauler, A, Dupont, Lj, Martinot, Jb, Ninane, V, Peché, R, Pilette, C, Dimitrova, R, Dimova, D, Kissyova Ibrishimova, G, Loboshka Becheva, M, Machkovska, M, Madjarov, S, Mandazhieva Pepelanova, M, Naidenova, I, Noleva, K, Takovska, N, Terziev, C, Aggarwal, Nk, Chapman, Kr, Csanadi, Ma, Dhillon, R, Henein, S, Kelly, Aj, Lam, As, Liem, Jj, Lougheed, Md, Lowe, Dw, Rizvi, Q, van den Berg, L, Zidel, B, Barros Monge MJ, Calvo Gil MA, Castillo Hofer CR, Diaz Amor PV, Lezana Soya, V, Quilodran Silva CN, Bolivar Grimaldos, F, Solarte-Rodriguez, I, Butkovic-Tomljanovic, R, Hegedus-Jungvirth, M, Ivkovic-Jurekovic, I, Simunov-Karuza, G, Buresova, M, Bursova, J, Fratrik, J, Guttlerova, E, Hartman, P, Jirmanova, I, Kalina, P, Kolman, P, Kucera, M, Povysilova, L, Pravda, P, Svabkova, A, Zakova, L, Backer, V, Maltbaek, N, Johnsen, Cr, Aries, Sp, Babyesiza, A, Barth, D, Benedix, A, Berg, P, Bergtholdt, B, Bettig, U, Bindig, Hw, Botzen, U, Brehler, R, Breyer, Go, Bruckhaus-Walter, M, Dapper, T, Eckhard, Jg, Engelhard, R, Feldmeyer, F, Fissan, H, Franz, Kh, Frick, Bs, Funck, J, Gessner, Cm, Ginko, T, Grigat, Ce, Grimm-Sachs, V, Groth, G, Hampf, J, Hanf, G, Havasi-Jost, G, Heinz, Gu, Helm, K, Hoeltz, S, Hofmann, S, Jander, R, Jandl, M, Jasch-Hoppe, B, Jung, T, Junggeburth, Jj, Kardos, P, Knueppel, W, Koch, T, Kolorz, C, Korduan, M, Korth-Wiemann, B, Krezdorn, Hg, Kroker, A, Kruell, M, Kuehne, P, Lenk, U, Liefring, E, Merke, J, Micke, L, Mitlehner, W, Mueller, H, Naudts, If, Neumann, G, Oldenburg, W, Overlack, A, Panzer, F, Reinholz, N, Remppis, R, Riegel, P, Rueckert, P, Schaetzl, Rj, Schauer, U, Hamelmann, E, Schenkenberger, I, Schlegel, V, Scholz, G, Schroers, M, Schwittay, A, Sebert, M, Tyler, K, Soemantri, Pa, Stock, P, Stuchlik, G, Unland, M, von Mallinckrodt, C, Wachter, J, Weber, U, Weberling, F, Wehgartner-Winkler, S, Weimer, J, Wiemer, S, Winkelmann, Ej, Zeisler, Kh, Ziegner, A, Zimny, Hh, Andrasofszky, Z, Bartha, A, Farkas, M, Gömöri, K, Kis, S, Major, K, Mészáros, I, Mezei, M, Rakvacs, M, Szalai, Z, Szántó, J, Szentesi, M, Szolnoki, E, Valyon, E, Zibotics, H, Anwar, J, Arimah, C, Djajalaksana, S, Rai, Ib, Setijadi, Ar, Setyanto, Db, Susanti, F, Syafiuddin, T, Syamsi, Ln, Wijanarko, P, Yunus, F, Bonavia, M, Braga, M, Chetta, Aa, Cerveri, I, Luisetti, M, Crimi, N, Cutrera, R, De Rosa, M, Esposito, S, Foresi, A, Gammeri, E, Iemoli, E, Legnani, Dl, Michetti, G, Pastorello, Ea, Pesci, A, Pistolesi, M, Riva, E, Romano, A, Scichilone, N, Terracciano, L, Tripodi, S, Choi, I, Kim, C, Kim, Js, Kim, Wj, Koh, Yy, Kwon, Ss, Lee, Sh, Lee, S, Lee, Sk, Park, Cs, Cirule, I, Eglite, R, Petrova, I, Poga, M, Smiltena, I, Chomiciene, A, Davoliene, I, Griskeviciene, V, Naudziunas, A, Naudziunas, S, Rudzeviciene, O, Sitkauskiene, B, Urbonas, G, Vaicius, D, Valavicius, A, Valiulis, A, Vebriene, J, bin Abdul Aziz FA, Daud, M, Ismail, Ai, Tengku Saifudin TI, Md Kassim RM, Mohd Fadzli FB, Wan Mohamad WH, Aguilar Dominguez PE, Aguilar-Orozco, Ra, Garza-Salinas, S, Ramirez-Diaz, Sp, Sánchez Llamas, F, Soto-Ramos, M, Velarde-Mora, Hj, Aguirre Sosa, I, Cisneros, Am, Estrella Viladegut RA, Matsuno Fuchigami, A, Adiaz-Baui, Tt, Bernan, Ap, Onia, Af, Sandagon, Mj, S-Naval, S, Yu, Cy, Bartuzi, Z, Bielous-Wilk, A, Błażowski, Ł, Bożek, A, Brzostek, J, Chorostowska-Wynimko, J, Ciekalska, K, Ziora, D, Cieslicki, J, Emeryk, A, Folcik, K, Gałuszka-Bilińska, A, Gawlik, R, Giejlo, M, Harat, R, Hofman, T, Jahnz-Różyk, K, Jedrzejczak, M, Kachel, T, Kamiński, D, Kelm Warchol, A, Konieczny, Z, Kwasniewski, A, Leszczyński, W, Mincewicz, G, Niezgoda, K, Olszewska-Ziąber, A, Onasz-Manitius, M, Pawlukiewicz, M, Piotrowicz, P, Piotrowski, W, Pisarczyk-Bogacka, E, Piskorz, P, Prokop-Staszecka, A, Roslan, A, Słomka, A, Smalera, E, Stelmach, I, Swierczynska-Krepa, M, Szmidt, M, Tarnowska-Matusiak, M, Tłuczykont, B, Tyminska, K, Waszkuc-Golonko, J, Wojciechowska, I, Alexandrescu, Ds, Neamtu, Ml, Todea, D, Alekseeva, E, Aleksandrova, E, Asherova, I, Barbarash, Ol, Bugrova, O, Bukreeva, Eb, Chermenskiy, A, Chizhova, O, Demko, I, Evdokimova, A, Giorgadze, Ml, Grigoryev, S, Irkhina, I, Khurkhurova, Nv, Kondyurina, Eg, Kostin, Vi, Kudelya, L, Laleko, Sl, Lenskaya, L, Levashov, S, Logvinenko, N, Martynov, A, Mizernitski, Y, Nemtsov, B, Novozhenov, Vg, Pavlishchuk, S, Popova, Vv, Reshetko, Ov, Sherenkov, A, Shirinsky, Vs, Shpagina, L, Soloviev, Ki, Tkachev, A, Trofimov, Vi, Vertkin, Al, Vorobeva, E, Idrisova, E, Yakushin, S, Zadionchenko, V, Zhiglinskaya, O, Zykov, K, Dopudja Pantic, V, Nadaskic, R, Nestorovic, B, Skodric Trifunovic, V, Stojanovic, A, Vukcevic, M, Vujic, T, Mitic Milikic, M, Banovcin, P, Horvathova, H, Karako, P Sr, Plutinsky, J, Pribulova, E, Szarazova, M, Zlatos, A, Adams, L, Badat, A, Bassa, A, Breedt, J, Bruning, A, Ellis, Gc, Emanuel, S, Fouche, Lf, Fulat, Ma, Gani, M, Ismail, Ms, Jurgens, Jc, Nell, H, Nieuwoudt, G, Noor, F, Bolliger, Ct, Puterman, As, Siddique, N, Trokis, Js, Vahed, Ya, Van Der Berg BJ, Van der Linden, M, Van Zyl, L, Visser, Ss, Antépara Ercoreca, I, Arnedillo Muñoz, A, Barbe Illa, F, Barreiro López, B, Blanco Aparicio, M, Boada Valmaseda, A, Bosque García, M, Bustamante Ruiz, A, Carretero Anibarro, P, Del Campo Matias, F, Echave-Sustaet, Jm, Espinosa de los Monteros Garde MJ, Garcia Hernandez GM, López Viña, A, Lores Obradors, L, Luengo Planas MT, Monsó Molas, E, Navarro Dourdil, A, Nieto García AJ, Perpina Tordera, M, Picado Valles, C, Rodriguez Alvarez Mdel, M, Saura Vinuesa, A, Serra Batlles, J, Soler Sempere MJ, Toran Montserrat, P, Valdés Cuadrado LG, Villasante Fernandez-Montes, C, Cheng, Sl, Chern, Jh, Chiu, Mh, Chung, Cl, Lai, Rs, Lin, Ck, Liu, Yc, Wang, Cc, Wei, Yf, Amer, L, Berenfus, Vi, Besh, L, Duka, Kd, Fushtey, Im, Garmash, N, Dudnyk, O, Godlevska, O, Vlasenko, Ma, Hospodarskyy, I, Iashyna, L, Kaladze, M, Khvelos, Si, Kostromina, Vp, Krakhmalova, O, Kryuchko, T, Kulynych, Ov, Krasko, Mp, Levchenko, O, Litvinova, T, Panina, Ss, Pasiyeshvili, Lm, Prystupa, Ln, Romaniuk, Li, Sirenko, I, Synenko, Vi, Vynnychenko, Lb, Yatsyshyn, Ri, Zaitsev, I, Zhebel, V, Zubarenko, O, Arthur, Cp, Brown, V, Burhan, H, Chaudhuri, R, Collier, D, Barnes, Nc, Davies, Ej, Ellery, A, Kwok, S, Lenney, W, Nordstrom, M, Pandya, Hc, Parker, Iw, Rajakulasingam, K, Seddon, P, Sharma, R, Thomas, Ec, Wakeling, Ja, Abalos-Galito, M, Abboy, C, Abreu, E, Ackerman, If, Acosta, Ia, Adaoag, Aa, Ahmed, M, Ali, Mi, Allen, Dr, Allen GG Jr, Diogo, Jj, Allison, Dc, Alwine, Lk, Apaliski, Sj, Arastu, Rs, Arora, Cm, Auerbach, D, Azzam, Sj, Badar FL 3rd, Baker, Jw, Barasch, Jp, Barber, Ma, Bardinas-Rodriguez, R, Barreiro, Tj, Baumbach, Rr, Baur, Ce, Baxter, Bs, Beach, Jl, Beasley, Rl, Beavins, Je, Beliveau, Wj, Benbow, Mj, Bennett, Nl, Bennett, Rl, Bernal, H, Bernstein, Di, Blaiss, Ms, Blumenthal, Kw, Boas, Sr, Borders, Jl, Boscia, Ja, Boulware, Wn, Bowling, Bt, Brabec, Ba, Bramlet, Dg, Figueroa, Dp, Brautigam, Df, Brownell, Jm, Bruce, Tr, Call, Rs, Campbell, Ca, Canaan, Ya, Cannon, Df, Carpio, Jm, Cathcart, Ws, Cevallos, Jp, Chauhan, Av, Chuang, Rb, Chevalier, D, Christensen, J, Christensen, Ta, Christina, Mo, Chrzanowski, Rr, Civitarese, Fa, Clark, Jp, Clifford, Dp, Lapidus, Rj, Coggi, Ja, Lenz, Jj, Cohen, Kr, Collins, Bg, Collins, H, Comellas, A, Condit, J, Cordasco EM Jr, Corder, Cn, Covar, Ra, Coverston, Kd, Croce, Sa, Cruz, H, Curtis, Ct, Daftary, Pk, Dalan, D, Dalawari, Sp, Daly, Wc, Davis, Kc, Dawes, Kw, Decotiis, Ba, Deluca, Rf, Desantis, Dm, De Valle OL, Diaz, Jl, Diaz, Jd, Dice, Jp, Elizalde, A, Hosler, Mr, Dixon, C, Dobkin, La, Dobrusin, Rs, Dransfield, Mt, Ebbeling, Wl, Edwards, Jd, Elacion, Jm, Elkayam, D, Ellison, Wt, Elsen, Jr, Engel, Lr, Ensz, Dj, Ericksen, Cl, Ervin, Je, Fang, C, Abrahamian, F, Farrah, Vb, Field, Jd, Fishman, Hj, Florea, R, Nayyar, S, Focil, A, Focauld, F, Franco MA Jr, Frandsen, Br, Ganti, K, Garcia, Fl, Lee, Wm, Garscadden, Ag, Gatti, Ea, Gellady, Am, George, Ar, Gibbon, Gw, Gleason, Gp, Goldberg, P, Goldstein, Mf, Gonzalez, Ge, Gower, Rg, Grande, Ja, Gregory, D, Grubb, Sd, Guthrie, Rp, Haas, Ta, Haft, Ks, Hajal, R, Hammond, Gd, Hansel, Nn, Hansen, Vr, Harris, Af, Hartman, An, Harvey, Rr, Hazan-Steinberg, S, Headley, Dm, Heigerick, Gc, Heller, Bn, Hendrix, El, Herrod, Jn, Hewitt, Mj, Hines, Rl, Hirdt, Ap, Hirschfield, Ja, Hoffman, Ks, Hogan, Ad, Howland, Wc, Hsu, Cc, Hsu, Fj, Hubbard, Wm, Hudson, Jd, Huffman, C, Hussain, M, Ioachimescu, Oc, Ismail, Ym, Jaffrani, Na, Jiang, N, Jones, Sw, Jordan, Rs, Joshi, Ke, Kaashmiri, Mw, Kalafer, M, Kamdar, Ba, Kanuga, Jg, Kao, Nl, Karetzky, M, Katsetos, Jc, Kay, Js, Kimmel, Ma, Kimura, Sh, Kingsley, Jk, Mahmood, Sm, Subich, Dc, Kirstein, Jl, Kleerup, Ec, Klein, Rm, Koh, Dw, Kohli, N, Koura, Fa, Kovacs, Sp, Kratzer, J, Kreit, Ci, Kreutter, Fm, Kubicki, Tm, Labuda, Jm, Latorre, Aj, Lara, Mm, Lechin, Ae, Lee, Jj, Lee, Md, Lentnek, Al, Lesh, Kw, Levins, Pf, Anspach, Rb, Levinsky, Dm, Lillestol, Mj, Lim, H, Livezey, Md, Lloyd-Turney, Cw, Lockey, Rf, Long, Ra, Lynch, Mj, Macgillivray, Bk, Mahadevan, Kp, Makam, Sk, Maloney, Mj, Mapel, D, Margolis, Bd, Margulies, J, Martin, Ef, Martin, Ee, Mascolo, M, Mataria, H, Sunbuli, M, Mathur, Rn, Mattar, Pn, Maynard, Km, Maynard, N, Mccormick, B, Mcelya, M, Mcevoy, Ce, Mckenzie, Wc, Medwedeff, Le, Mehta, Kd, Melamed, Ir, Meli, Jv, Merrick, Bh, Meyers, Pj, Miller, Bt, Minton, Sm, Miranda, Fg, Mohar, De, Montenegro, Ch, Morris, Fa, Morrison, Bs, Moss, Mh, Munoz, F, Naini, Gr, Nakamura, Ct, Naseeruddin, S, Nassim, C, Navazo, Lj, Nissim, Je, Norman, D, Oberoi, Ms, O'Connor, Tm, Offenberger, J, Orr, Rr, Osea, Ea, Paine, Wj, Rasmussen, Nl, Palatnik, M, Pangtay, D, Panuto, Ja, Patel, M, Perera, Ms, Perez, A, Peters PH Jr, Pimentel SM Jr, Pluto, Tm, Pollock, Mt, Posner, Ls, Pritchard, Jc, Pudi, Kk, Puig, Cm, Qaqundah, Py, Radbill, Mk, Rahman, St, Raikhel, M, Raissy, Hh, Ramstad, Ds, Ranasinghe, Es, Rangel, Os, Rapo, Se, Raschal, Sp, Reddy, Dg, Rehman, Sm, Reyes, Sr, Rhodes, Rb, Riffer, E, Rihal, Ps, Riley ED 4th, Rodriguez, Dh, Rogers, Cm, Rohlf, Jl, Romeu, H, Roney, Cw, Ronsick, So, Rosen, Jb, Rowe, Ms, Ruoff, Ge, Ryan, Eh, Saff, Rh, Saini, N, Anand, S, Balakrishnan, K, Samuels, Bs, Samuelson, Rj, Saniuk, Rj, Sargeant, Wo, Saunders, Mk, Saway, W, Scarupa, Md, White, Mv, Schear, Mj, Schwarz, Cm, Scott, Rb, Segall, N, Seibert, Af, Seidmeyer, V, Seidner, Mr, Seifer, Fd, Serje, J, Shah, Ms, Shah, Sb, Shapero, Pa, Shearer, Sd, Sheikh, Sq, Shepherd, Ts, Sher, Er, Sher, Ld, Short, Bh, Silas, Pe, Alvey, Jc, Silverfield, Jc, Simon, Sj, Sitar, S, Skoner, Dp, Smallow, Sa, Smart, Ba, Smith, Ca, Smith, Ke, Smith, Sk, Snyders, Gc, Soong, W, Soufer, J, Spangenthal, S, Stahlman, Je, Steele, Lg, Stegemoller, Rk, Stocks, J, Storms, Ww, Suen, J, Surowitz, Rz, Swauger, Jr, Taber, La, Tan, Ae, Pratt, Se, Tanus, T, Tarpay, Mm, Tarshis, Ga, Tenney, Jw, Tilghman, Kg, Trevino, Me, Troyan, Be, Twiddy, Sk, Updegrove, Jd, Urval, Kr, Uusinarkaus, Kt, Vaela, R, Van Cleeff, M, Varano, S, Vo, Qd, Wainz, Rj, Wald, Ja, Wall, Sj, Wasserman, Rl, Weinstein, Dl, Welker, Ja, Wellmon, B 2nd, Wells, T, Wenocur, Hs, Williams, Dl, Williams, Sl, Win, Ph, Wingo, Td, Wisman PP Jr, Wyszomierski, Da, Yamada, Hm, Yarows, S, Yunger TM Jr, Ziering, Rw., the AUSTRI Investigators, Stempel, D., Raphiou, I., Kral, K., Yeakey, A., Emmett, A., Prazma, C., Buaron, K., and Pascoe, S. Scichilone N tra i collaboratori

Subjects
Male, asthma, serious events, fluticasone, salmeterol, AUSTRI, Exacerbation, Intention to Treat Analysi, INHALED CORTICOSTEROIDS, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, law, immune system diseases, Ús terapèutic, Broncodilatadors, 030212 general & internal medicine, Child, Fluticasone, RISK, ACTING BETA-AGONISTS, EXACERBATIONS, METAANALYSIS, MORTALITY, SAFETY, DEATH, FDA, Medicine (all), Hazard ratio, General Medicine, Bronchodilator agents, Middle Aged, Fluticasone-Salmeterol Drug Combination, Bronchodilator Agents, Intention to Treat Analysis, Anesthesia, Female, Salmeterol, medicine.drug, Human, Adult, medicine.medical_specialty, Adolescent, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Fluticasone propionate, 03 medical and health sciences, Double-Blind Method, Internal medicine, Administration, Inhalation, medicine, Humans, Asma, Bronchodilator Agent, Asthma, Aged, Proportional Hazards Models, business.industry, Therapeutic use, medicine.disease, respiratory tract diseases, 030228 respiratory system, Fluticasone Propionate, Salmeterol Xinafoate Drug Combination, Proportional Hazards Model, business
Abstract

BACKGROUND The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. METHODS In this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of lifethreatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone–salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. RESULTS Of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone–salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthmarelated event in the fluticasone–salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P = 0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthmarelated intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone–salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone–salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P

Published
2016

12. Management of parapneumonic pleural effusions,Tratamiento de los derrames pleurales paraneumónicos

Author

Asensio La Cruz, O., Blanco González, J., Moreno Galdó, A., Pérez Frías, J., Salcedo Posadas, A., Sanz Borrell, L., Álvarez Gil, D., Alzina Aguilar, V., Anselmo Andrés-Martín, Antelo Landeira, C., Barrio Gómez Agüero, I., Bermejo Pastor, M., Bonillo Perales, A., Bosque García, M., Cabrera Roca, G., Carrasco Zalvide, M., Cortell Aznar, I., Elorz Lambarri, J., Escribano Montaner, A., Figuerola, J., Frías Morales, M. D., Gómez-Pastrana Durán, D., Landaluce Ugarte, C., Liñán Cortés, S., Machuca Contreras, M., Martínez, C., Oliva Hernández, C., Pascual Sánchez, M. T., Pardos Rocamora, L., Pérez Pérez, G., Pérez Ruiz, E., Reverté Bover, C., Sánchez Jiménez, J., Sánchez Sánchez, E., Sequeiros González, A., Sirvent Gómez, J., Tabarés Lezcano, J. M., Torres Simón, J. M., Ubeda Sansano, M. I., and Villa Asensi, J. R.

13. Impact of 1-Year Supplementation with High-Rich Docosahexaenoic Acid (DHA) on Clinical Variables and Inflammatory Biomarkers in Pediatric Cystic Fibrosis: A Randomized Double-Blind Controlled Trial.

Author

Ayats-Vidal R, Bosque-García M, Cordobilla B, Asensio-De la Cruz O, García-González M, Loureda-Pérez S, Fernández-López E, Robert-Barriocanal E, Valiente-Planas A, and Domingo JC

Subjects
Humans, Child, Docosahexaenoic Acids, Anthropometry, Biomarkers, Dietary Supplements, Cystic Fibrosis drug therapy
Abstract

A randomized, double-blind, and placebo-controlled study was conducted to assess the effect of dietary supplementation with high-rich docosahexaenoic acid (DHA) (Tridocosahexanoin-AOX ® 70%) at 50 mg/kg/day in pediatric patients with cystic fibrosis (CF) as compared with placebo. The duration of supplementation was 12 months. A total of 22 patients were included, with 11 in the DHA group and 11 in the placebo group. The mean age was 11.7 years. The outcome variables were pulmonary function, exacerbations, sputum cellularity, inflammatory biomarkers in sputum and peripheral blood, and anthropometric variables. In the DHA group, there was a significant increase in FVC ( p = 0.004) and FVE 1 expressed in liters ( p = 0.044) as compared with placebo, and a lower median number of exacerbations (1 vs. 2). Differences in sputum cellularity (predominantly neutrophilic), neutrophilic elastase, and sputum and serum concentrations of resolvin D1 (RvD1), interleukin (IL)-8 (IL-8), and tumor necrosis factor alpha (TNF-α) between the study groups were not found. Significant increases in weight and height were also observed among DHA-supplemented patients. The administration of the study product was safe and well tolerated. In summary, the use of a highly concentrated DHA supplement for 1 year as compared with placebo improved pulmonary function and reduced exacerbations in pediatric CF., Competing Interests: The authors declare no conflicts of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Published
2024
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14. Changes of Erythrocyte Fatty Acids after Supplementation with Highly Concentrated Docosahexaenoic Acid (DHA) in Pediatric Cystic Fibrosis: A Randomized Double-Blind Controlled Trial.

Author

Ayats-Vidal R, Bosque-García M, Cordobilla B, Asensio-De la Cruz O, García-González M, Castro-Marrero J, López-Rico I, and Domingo JC

Abstract

We characterized the fatty acid profiles in the erythrocyte membrane of pediatric patients with cystic fibrosis (CF) receiving highly concentrated docosahexaenoic acid (DHA) supplementation (Tridocosahexanoin-AOX ® 70%) at 50 mg/kg/day ( n = 11) or matching placebo ( n = 11) for 12 months. The mean age was 11.7 years. The DHA group showed a statistically significant improvement in n-3 polyunsaturated fatty acids (PUFAs), which was observed as early as 6 months and further increased at 12 months. Among the n-3 PUFAs, there was a significant increase in DHA and eicosapentaenoic acid (EPA). Additionally, a statistically significant decrease in n-6 PUFAs was found, primarily due to a decrease in arachidonic acid (AA) levels and elongase 5 activity. However, we did not observe any changes in linoleic acid levels. The long-term administration of DHA over one year was safe and well tolerated. In summary, the administration of a high-rich DHA supplement at a dose of 50 mg/kg/day for one year can correct erythrocyte AA/DHA imbalance and reduce fatty acid inflammatory markers. However, it is important to note that essential fatty acid alterations cannot be fully normalized with this treatment. These data provide timely information of essential fatty acid profile for future comparative research.

Published
2023
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15. Cost-effectiveness of omalizumab for the treatment of severe pediatric allergic asthma-Results of a real-life study in Spain.

Author

Nieto-Cid M, Garriga-Baraut T, Plaza-Martín AM, Tortajada-Girbés M, Torres-Borrego J, Lozano-Blasco J, Moreno-Galarraga L, Del Mar Folqué-Giménez M, Bosque-García M, Gaboli M, López-Neyra A, Rivas-Juesas C, Caballero-Rabasco MA, Freixa-Benavente A, Valdesoiro-Navarrete L, de Mir-Messa I, Ballester-Asensio E, Penín-Antón M, Romero-García R, Navarro-Morón J, Valenzuela-Soria A, Sánchez-Mateos M, Batlles-Garrido J, Sanz-Santiago V, de Atauri ÁG, Andrés-Martín A, Campos-Alonso E, Gómez-Pastrana D, Vázquez-Rodríguez E, Martínez-Pardo L, Del Río-Camacho G, Mazón-Ramos Á, and Nieto-García A

Subjects
Humans, Child, Omalizumab therapeutic use, Cost-Benefit Analysis, Spain, Retrospective Studies, Treatment Outcome, Quality of Life, Anti-Asthmatic Agents therapeutic use, Asthma therapy
Abstract

Background: Severe pediatric allergic asthma (SPAA) induces a huge economic burden in terms of direct, indirect, and intangible costs. The use of omalizumab for the treatment of these patients has produced a significant improvement in several clinical outcomes, but at the same time, the cost for the management of the disease has also increased. The aim of this report was to evaluate whether the use of omalizumab is cost-effective., Methods: A sample of 426 children with SPAA from the ANCHORS (Asthma iN CHildren: Omalizumab in Real-life in Spain) study was used to calculate the incremental cost-effectiveness ratio (ICER) for the avoidance of moderate-to-severe exacerbations (MSE) and also for the improvement in childhood Asthma Control Test (c-ACT) or the Asthma Control Questionnaire (ACQ5). We retrospectively collected data on health encounters and drug consumption before and up to 6 years after the beginning of the treatment with omalizumab., Results: The ICER per avoided MSE was €2107 after 1 year, and it consistently decreased to €656 in those followed up to 6 years. Similarly, the ICER for the minimally important difference in control tests showed a decrease from €2059 to €380 per each 0.5 points of improvement in ACQ5 and from €3141 to €2322 per each 3 points improvement in c-ACT, at years 1 and 6, respectively., Conclusion: The use of OMZ is a cost-effective option for most children with uncontrolled SPAA, especially those who have frequent exacerbations; the costs are progressively reduced in successive years of treatment., (© 2023 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)

Published
2023
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16. Long-term outcome of omalizumab-assisted desensitisation to cow's milk and eggs in patients refractory to conventional oral immunotherapy: real-life study.

Author

Ayats-Vidal R, Riera-Rubió S, Valdesoiro-Navarrete L, García-González M, Larramona-Carrera H, Cruz OA, and Bosque-García M

Subjects
Administration, Oral, Animals, Cattle, Chickens, Child, Desensitization, Immunologic adverse effects, Female, Humans, Immunologic Factors, Milk adverse effects, Omalizumab therapeutic use, Retrospective Studies, Anaphylaxis etiology, Milk Hypersensitivity therapy
Abstract

Background: Oral immunotherapy (OIT) is a promising approach to cow's milk and egg allergies, but reactions are frequent and some patients cannot be desensitized., Objective: To evaluate long-term OIT outcomes with omalizumab (OMZ) in paediatric patients with severe egg and/or milk allergies., Methods: This retrospective real-life study analysed findings in children with Immunoglobulin E-mediated allergy to cow's milk and/or hen eggs refractory to conventional OIT, who underwent OIT with OMZ in our department between 1 January 2010 and 31 December 2015., Results: In all, 41 patients were included (median age: 7 years; interquartile range [IQR]: 5.5-9.5); 26/41 (63.4%) underwent OIT for milk, 8/41 (19.5%) for egg and 7/41 (17.1%) for both. The median time between initiation of OMZ and OIT was 27 weeks (IQR: 22-33). Forty (97.56%) patients reached the maintenance phase (200 mL of cow's milk and 30 mL of raw egg or 1 cooked egg) in a median time of 27 weeks (IQR: 18-37). The median total time with OMZ was 117 weeks (IQR: 88-144). During the OMZ period, 2.44% (1/41) of patients presented anaphylaxis. After discontinuation of OMZ, 29.3% (12/41) presented anaphylaxis, 50% of them had a poor adherence to daily ingestion. One patient (2.44%) was diagnosed with eosinophilic esophagitis after 2 years of discontinuation of OMZ. Currently, after a median time of 9 years (IQR: 7-10) since the initiation of OMZ, 75.6% (31/41) are desensitized (27/31 without OMZ)., Conclusions: Omalizumab allows desensitisation of children with severe allergies to cow's milk and/or egg without developing severe reactions while receiving this treatment. However, discontinuation of OMZ leads to severe allergic reactions, and hence must be monitored carefully.

Published
2022
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17. Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma.

Author

Nieto García A, Garriga-Baraut T, Plaza Martín AM, Nieto Cid M, Torres Borrego J, Folqué Giménez MDM, Lozano Blasco J, Bosque García M, Moreno-Galarraga L, Tortajada-Girbés M, Rivas Juesas C, Penín Antón M, Caballero-Rabasco MA, Gaboli M, López Neyra A, Navarro Morón J, Freixa Benavente A, Valdesoiro Navarrete L, Ballester Asensio E, Sanz Santiago V, Romero García R, Gimeno Díaz de Atauri Á, Valenzuela Soria A, Sánchez Mateos M, Batlles Garrido J, Andrés Martín A, Campos Alonso E, Aragón Fernández C, Vázquez Rodríguez E, Martínez Pardo L, Del-Río Camacho G, and Mazón Ramos Á

Subjects
Anti-Asthmatic Agents adverse effects, Antibodies, Monoclonal, Humanized adverse effects, Child, Humans, Omalizumab adverse effects, Retrospective Studies, Treatment Outcome, Anti-Asthmatic Agents therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Asthma drug therapy, Omalizumab therapeutic use
Abstract

Background: Various studies have assessed omalizumab outcomes in the clinical practice setting but follow-up and/or number of patients included were limited. We aim to describe the long-term outcomes of pediatric patients with severe persistent allergic asthma receiving omalizumab in the largest real-life cohort reported to date., Methods: ANCHORS was a multicenter, observational, retrospective cohort study conducted in 25 Pediatric Allergy and Pulmonology units in Spain. We collected data of patients < 18 years and initiating omalizumab between 2006 and 2018, from the year prior to omalizumab initiation to discontinuation or last available follow-up. The primary outcome was the evolution of the annual number of moderate-to-severe exacerbations compared with the baseline period., Results: Of the 484 patients included, 101 (20.9%) reached 6 years of treatment. The mean ± standard deviation number of exacerbations decreased during the first year of treatment (7.9 ± 6.6 to 1.1 ± 2.0, P < .001) and remained likewise for up to 6 years. The other clinical parameters assessed also improved significantly during the first year and stabilized or continued to improve thereafter. The percentage of patients experiencing adverse events was consistently low, and the main reason for discontinuation was good disease evolution., Conclusion: In this large, long-term, observational study, moderate-to-severe exacerbations decreased significantly from the first year of treatment with omalizumab. The beneficial effect was maintained in the long term, along with a good safety profile. Our results position omalizumab as an effective long-term treatment in pediatric patients with severe persistent allergic asthma., (© 2021 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.)

Published
2021
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18. Characterization of severe asthma in the pediatric population.

Author

Perez AV, Pol AB, Hernandez ER, Lorenzo MG, Serra AG, and Bosque-García M

Subjects
Adolescent, Asthma blood, Asthma drug therapy, Asthma immunology, Child, Dermatitis, Atopic immunology, Female, Humans, Leukocyte Count, Male, Medication Adherence statistics & numerical data, Rhinitis, Allergic, Perennial immunology, Risk Factors, Severity of Illness Index, Tobacco Smoke Pollution adverse effects, Tobacco Smoke Pollution statistics & numerical data, Anti-Asthmatic Agents therapeutic use, Asthma diagnosis, Dermatitis, Atopic epidemiology, Eosinophils immunology, Rhinitis, Allergic, Perennial epidemiology
Abstract

Introduction and Objectives: Relationship between the causal mechanisms of pediatric severe asthma and severity of symptoms would be helpful for developing personalized strategies for treatment and prevention., Materials and Methods: For this study, 698 medical histories of asthmatics between 6 and 18 years of age were reviewed in a period of 2 years. Variables analyzed were: age, sex, ethnicity, perinatological history, allergy history, asthma predictive index (API), exposure to tobacco, heavy traffic or epithelium, lung function, age of onset of symptoms, hospitalization admissions/PICU, systemic corticosteroids, daily symptoms control, device prescribe for daily control, and adherence., Results: A total of 86 children with severe asthma were included (12.3%). Mean age 13.3 +/- 1.86 years, sex ratio1:1, mean age of symptom onset 2.765 +/- 3.06 years, mean IgE 1076.18KU / L +/- 1136, mean eosinophils 604c / mcl +/- 511.9, mean of FEV1 93.15% +/- 16.3. Evidently, 70 children (81.4%) had positive API, 68 (79.1%) rhinitis, 34 (39.5%) atopic dermatitis. 73 (83.9%) sensitized to inhalants and 56 (65.1%) to dermatophagoides, 39 (45.3%) passive smokers, 19 (22.1%) exposure to heavy traffic; 55 (64%) showed symptoms with exercise, 35 (40.7%) had audible wheezing. The mean systemic corticosteroid cycles/year was 3.63 +/- 3.23, mean PICU admissions 0.36 +/- 0.83, mean hospital admissions 4.31 +/- 5.3, average emergency room visits/year 19.44 +/- 16.28. 38 (56.7%) had good adherence, 44 (51%) used an MDI device and 39 (45.3%) used dry powder., Conclusions: Children with severe asthma meet the following criteria: premature, positive API, rhinitis, atopic dermatitis, high IgE, eosinophilia, passive smokers, exposure to heavy traffic, decreased lung function, and low adherence to controller medication., Competing Interests: No conflict of interest is reported by the authors.

Published
2021
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21. [Efficiency of methotrexate in the treatment of cortico-dependent asthmatic patients].

Author

Domingo Ribas C, Comet Monte R, Bosque García M, Morón Besolí A, and Montón Soler C

Subjects
Adolescent, Adult, Aged, Asthma physiopathology, Female, Forced Expiratory Volume, Glucocorticoids therapeutic use, Humans, Male, Methylprednisolone therapeutic use, Middle Aged, Prospective Studies, Asthma drug therapy, Immunosuppressive Agents therapeutic use, Methotrexate therapeutic use
Abstract

Objective: To evaluate the efficiency of low doses of methotrexate as corticosteroid sparing agent in asthmatic patients requiring long term corticosteroid therapy., Methods: A prospective study was conducted with seven adult patients and one female pediatric patient suffering from corticosteroid-dependent bronchial asthma. The minimal stabilization time for each patient before initiating treatment with MTX was 3 months. The administered dose of methotrexate was 10 mg/week p.o. for adult patients and 15 mg/week for the pediatric patient. Dose tapering of methyl-prednisolone both during the stabilization and therapy periods was a 2 mg decrease every two weeks provided that no worsening in FEV1 higher than 5% occurred., Results: For the group of adult patients, the stabilization time was 5.6 +/- 2.7 months. Methyl-prednisolone dose during the stabilization period could be decreased from 15.0 mg down to 25.4 +/- 12.0 mg (p = 0.013). The period of treatment of methotrexate was 7.3 +/- 3.4 months and the dose of methyl-prednisolone could be decreased from 25.4 +/- 12.0 mg down to 12.0 +/- 11.9 mg (p < 0.001). In the pediatric patient, the deflazacor dose was decreased from 60 down to 30 mg/day during treatment with methotrexate. In all patients a significant decrease could be obtained in the MP dose during treatment with methotrexate with no decrease in FEV1. No secondary effects were observed with the exception of a labial herpes in the pediatric patient., Conclusions: The administration of one single weekly dose of methotrexate 10 mg in adults and 15 in one pediatric patient allowed for a decrease of approximately 50% in the glucocorticosteroid dosage in this group of patients with corticosteroid-dependent bronchial asthma with no relevant adverse reactions during therapy.

Published
1999

22. [Cystic fibrosis: a new disease in adults].

Author

Asensio de la Cruz O, Bosque García M, and Marco Valls MT

Subjects
Adolescent, Adult, Age of Onset, Child, Child, Preschool, Female, Humans, Infant, Male, Pseudomonas aeruginosa isolation & purification, Sputum microbiology, Cystic Fibrosis diagnosis
Abstract

Objective: Cystic fibrosis (CF) has undergone substantial epidemiological changes. The life expectancy of CF patients and the proportion of affected adults are rising because of advances in diagnosis and treatment. In order to find out more about our current situation, we sent an anonymous questionnaire to all affected members of the Catalonian Association of CF., Patients and Methods: The questionnaire was sent to 180 patients and their parents asking for information about demographical aspects, diagnosis, pulmonary function, microbiological data, complications, treatment, number of medical visits to CF centers, personal, social and professional development, and the degree of satisfaction with the medical care received., Results: The questionnaire was correctly completed by 75 patients. Of these, 20% were older than 18 years of age. The mean age at diagnosis was 3.25 years. The initial symptoms were: meconium ileus (8%), growth retardation (24%), respiratory problems (34%) and gastrointestinal problems (36%). Sixty percent of the patients showed positive sputum cultures. The most frequently isolated microorganism was P. aeruginosa. Apart form the usual therapy with antibiotics, enzyme replacement and vitamin supplements, other therapeutic measures employed included: alimentary supplements (54%), mucolitics (27%), bronchodilators (45%) and inhaled anti-inflammatories (20%). Complications were present in 56% of the patients and these included hemoptysis, polyps, rectal prolapse, hepatic disease, diabetes, psychological changes, biliary litiasis, pneumothorax, infertility or pancreatitis. The proportion of positive sputum cultures, the type of germ identified and the complications observed changed according to the patient's age., Conclusions: National registers can be very useful tools to make public health plans. They are also good instruments to evaluate the progress made in the treatment of diseases such as CF.

Published
1997

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