Studie srovnávající udržovací a úlevovou péči o pěstounskou účinnost oproti péči o pěstounskou péči + salbutamol u astmatiků
48týdenní, mnohonárodní, randomizované, dvojitě zaslepené, 2 paralelní skupiny, porovnání účinnosti Foster pro udržovací a úlevovou léčbu versus fixní dávka Fosteru pro údržbu plus Salbutamol jako zmírňující prostředek u astmatiků >=18 let
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Burgas, Bulharsko
- Chiesi Site No 103
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Pleven, Bulharsko
- Chiesi Site No 107
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Plovdiv, Bulharsko
- Chiesi Site No 105
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Plovdiv, Bulharsko
- Chiesi Site No 111
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Plovdiv, Bulharsko
- Chiesi Site No 115
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Rousse, Bulharsko
- Chiesi Site No 102
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Sofia, Bulharsko
- Chiesi Site No 104
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Sofia, Bulharsko
- Chiesi Site No 108
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Sofia, Bulharsko
- Chiesi Site No 109
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Sofia, Bulharsko
- Chiesi Site No 110
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Sofia, Bulharsko
- Chiesi Site No 113
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Sofia, Bulharsko
- Chiesi Site No 117
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Stara Zagora, Bulharsko
- Chiesi Site No 106
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Troyan Municipality, Bulharsko
- Chiesi Site No 116
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Varna, Bulharsko
- Chiesi Site No 0101
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Veliko Tarnovo, Bulharsko
- Chiesi Site No 112
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Osijek, Chorvatsko
- Chiesi Site No 305
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Rijeka, Chorvatsko
- Chiesi Site No 304
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Zadar, Chorvatsko
- Chiesi Site No 306
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Zagreb, Chorvatsko
- Chiesi Site No 301
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Zagreb, Chorvatsko
- Chiesi Site No 302
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Zagreb, Chorvatsko
- Chiesi Site No 307
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Angoulême, Francie
- Chiesi Site No 428
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Castelnau-le-Lez, Francie
- Chiesi Site No 421
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Chauny, Francie
- Chiesi Site No 434
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Dijon, Francie
- Chiesi Site No 403
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Hyères, Francie
- Chiesi Site No 408
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Marmande, Francie
- Chiesi Site No 424
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Marseille, Francie
- Chiesi Site No 410
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Marseille, Francie
- Chiesi Site No 436
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Montpellier, Francie
- Chiesi Site No 418
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Nice, Francie
- Chiesi Site No 417
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Nîmes, Francie
- Chiesi Site No 435
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Ollioules, Francie
- Chiesi Site No 426
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Paris, Francie
- Chiesi Site No 401
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Paris, Francie
- Chiesi Site No 423
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Perpignan, Francie
- Chiesi Site No 404
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Poitiers, Francie
- Chiesi Site No 405
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Pézenas, Francie
- Chiesi Site No 425
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Saint-Etienne, Francie
- Chiesi Site No 416
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Saint-Girons, Francie
- Chiesi Site No 420
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Saint-Michel, Francie
- Chiesi Site No 402
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Saint-Quentin, Francie
- Chiesi Site No 411
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Soissons, Francie
- Chiesi Site No 406
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Toulon, Francie
- Chiesi Site No 422
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Toulon, Francie
- Chiesi Site No 432
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Verdun, Francie
- Chiesi Site No 414
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Benevento, Itálie
- Chiesi Site No 606
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Brescia, Itálie
- Chiesi Site No 633
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Castrovillari, Itálie
- Chiesi Site No 632
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Cittadella, Itálie
- Chiesi Site No 612
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Crema, Itálie
- Chiesi Site No 607
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Ferrara, Itálie
- Chiesi Site No 601
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Foggia, Itálie
- Chiesi Site No 610
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Genova, Itálie
- Chiesi Site No 604
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Genova, Itálie
- Chiesi Site No 605
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Impruneta, Itálie
- Chiesi Site No 619
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Messina, Itálie
- Chiesi Site No 631
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Milan, Itálie
- Chiesi Site No 627
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Milan, Itálie
- Chiesi Site No 636
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Modena, Itálie
- Chiesi Site No 608
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Montescano, Itálie
- Chiesi Site No 611
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Naples, Itálie
- Chiesi Site No 635
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Palermo, Itálie
- Chiesi Site No 603
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Palermo, Itálie
- Chiesi Site No 624
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Palermo, Itálie
- Chiesi Site No 630
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Parma, Itálie
- Chiesi Site No 615
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Perugia, Itálie
- Chiesi Site No 628
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Pietra Ligure, Itálie
- Chiesi Site No 613
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Pisa, Itálie
- Chiesi Site No 602
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Reggio Calabria, Itálie
- Chiesi Site No 625
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Roma, Itálie
- Chiesi Site No 618
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Roma, Itálie
- Chiesi Site No 626
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Sesto San Giovanni, Itálie
- Chiesi Site No 609 "Sesto San Giovanni (MI)"
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Vicenza, Itálie
- Chiesi Site No 614
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Bochum, Německo
- Chiesi Site No 514
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Bonn, Německo
- Chiesi Site No 520
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Cologne, Německo
- Chiesi Site No 510
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Dortmund, Německo
- Chiesi Site No 502
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Duisburg, Německo
- Chiesi Site No 516
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Düren, Německo
- Chiesi Site No 504
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Frankfurt, Německo
- Chiesi Site No 503
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Frankfurt, Německo
- Chiesi Site No 511
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Hagen, Německo
- Chiesi Site No 506
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Hamburg, Německo
- Chiesi Site No 513
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Koblenz, Německo
- Chiesi Site No 508
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Koblenz, Německo
- Chiesi Site No 509
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Krefeld, Německo
- Chiesi Site No 519
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Ludwigshafen, Německo
- Chiesi Site No 512
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München, Německo
- Chiesi Site No 505
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Neuss, Německo
- Chiesi Site No 515
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Weyhe, Německo
- Chiesi Site No 501
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Witten, Německo
- Chiesi Site No 518
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Bialystok, Polsko
- Chiesi Site No 720
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Bialystok, Polsko
- Chiesi Site No 724
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Bialystok, Polsko
- Chiesi Site No 741
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Bielsko-Biala, Polsko
- Chiesi Site No 729
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Gdansk, Polsko
- Chiesi Site No 709
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Gdansk, Polsko
- Chiesi Site No 719
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Gdynia, Polsko
- Chiesi Site No 738
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Giżycko, Polsko
- Chiesi Site No 707
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Iława, Polsko
- Chiesi Site No 704
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Katowice, Polsko
- Chiesi Site No 705
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Katowice, Polsko
- Chiesi Site No 739
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Krakow, Polsko
- Chiesi Site No 711
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Krakow, Polsko
- Chiesi Site No 721
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Krakow, Polsko
- Chiesi Site No 722
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Krakow, Polsko
- Chiesi Site No 727
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Krakow, Polsko
- Chiesi Site No 728
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Legionowo, Polsko
- Chiesi Site No 716
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Lodz, Polsko
- Chiesi Site No 701
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Lodz, Polsko
- Chiesi Site No 702
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Lodz, Polsko
- Chiesi Site No 703
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Lodz, Polsko
- Chiesi Site No 713
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Lodz, Polsko
- Chiesi Site No 723
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Lodz, Polsko
- Chiesi Site No 726
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Lodz, Polsko
- Chiesi Site No 736
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Lodz, Polsko
- Chiesi Site No 740
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Lubin, Polsko
- Chiesi Site No 715
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Lublin, Polsko
- Chiesi Site No 718
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Lublin, Polsko
- Chiesi Site No 730
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Ostróda, Polsko
- Chiesi Site No 735
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Proszowice, Polsko
- Chiesi Site No 725
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Rzeszów, Polsko
- Chiesi Site No 737
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Starachowice, Polsko
- Chiesi Site No 710
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Strzelce Opolskie, Polsko
- Chiesi Site No 708
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Sucha Beskidzka, Polsko
- Chiesi Site No 706
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Warsaw, Polsko
- Chiesi Site No 742
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Wilkowice, Polsko
- Chiesi Site No 732
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Wroclaw, Polsko
- Chiesi Site No 712
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Wroclaw, Polsko
- Chiesi Site No 733
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Zabrze, Polsko
- Chiesi Site No 714
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Łomża, Polsko
- Chiesi Site No 717
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Brasov, Rumunsko
- Chiesi Site No 805
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Bucharest, Rumunsko
- Chiesi Site No 801
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Bucharest, Rumunsko
- Chiesi Site No 807
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Bucharest, Rumunsko
- Chiesi Site No 808
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Cluj-Napoca, Rumunsko
- Chiesi Site No 810
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Constanța, Rumunsko
- Chiesi Site No 806
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Iași, Rumunsko
- Chiesi Site No 804
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Târgu Mureş, Rumunsko
- Chiesi Site No 811
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Moscow, Rusko
- Chiesi Site No 901
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Moscow, Rusko
- Chiesi Site No 902
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Moscow, Rusko
- Chiesi Site No 903
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Moscow, Rusko
- Chiesi Site No 904
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Moscow, Rusko
- Chiesi Site No 905
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Moscow, Rusko
- Chiesi Site No 906
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Moscow, Rusko
- Chiesi Site No 907
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Moscow, Rusko
- Chiesi Site No 916
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Moscow, Rusko
- Chiesi Site No 917
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Moscow, Rusko
- Chiesi Site No 918
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Ryazan, Rusko
- Chiesi Site No 915
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Saratov, Rusko
- Chiesi Site No 913
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Saratov, Rusko
- Chiesi Site No 914
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Yaroslavl, Rusko
- Chiesi Site No 908
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Yaroslavl, Rusko
- Chiesi Site No 909
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Yaroslavl, Rusko
- Chiesi Site No 910
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Yaroslavl, Rusko
- Chiesi Site No 911
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Yaroslavl, Rusko
- Chiesi Site No 912
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Glasgow, Spojené království
- Chiesi Site No 1301
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Hereford, Spojené království
- Chiesi Site No 1306
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Newcastle, Spojené království
- Chiesi Site No 1305
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Belgrade, Srbsko
- Chiesi Site No 1001
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Belgrade, Srbsko
- Chiesi Site No 1003
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Kamenitz, Srbsko
- Chiesi Site No 1002
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Kragujevac, Srbsko
- Chiesi Site No 1004
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Niš, Srbsko
- Chiesi Site No 1005
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Adana, Turecko (Türkiye)
- Chiesi Site No 1216
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Ankara, Turecko (Türkiye)
- Chiesi Site No 1213
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Aydin, Turecko (Türkiye)
- Chiesi Site No 1204
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Gaziantep, Turecko (Türkiye)
- Chiesi Site No 1203
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Istanbul, Turecko (Türkiye)
- Chiesi Site No 1208
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Istanbul, Turecko (Türkiye)
- Chiesi Site No 1214
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Istanbul, Turecko (Türkiye)
- Chiesi Site No 1215
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Izmir, Turecko (Türkiye)
- Chiesi Site No 1217
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Kayseri, Turecko (Türkiye)
- Chiesi Site No 1201
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Kirikkale, Turecko (Türkiye)
- Chiesi Site No 1202
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Konya, Turecko (Türkiye)
- Chiesi Site No 1207
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Malatya, Turecko (Türkiye)
- Chiesi Site No 1211
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Manisa, Turecko (Türkiye)
- Chiesi Site No 1210
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Tokat Province, Turecko (Türkiye)
- Chiesi Site No 1205
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Trabzon, Turecko (Türkiye)
- Chiesi Site No 1209
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Donetsk, Ukrajina
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Kharkiv, Ukrajina
- Chiesi Site No 1401
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Kharkiv, Ukrajina
- Chiesi Site No 1406
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Kharkiv, Ukrajina
- Chiesi Site No 1407
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Kharkiv, Ukrajina
- Chiesi Site No 1408
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Kharkiv, Ukrajina
- Chiesi Site No 1417
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Kharkiv, Ukrajina
- Chiesi Site No 1418
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Kiev, Ukrajina
- Chiesi Site No 1402
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Kiev, Ukrajina
- Chiesi Site No 1403
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Luhansk, Ukrajina
- Chiesi Site No 1405
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Odesa, Ukrajina
- Chiesi Site No 1412
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Simferopol, Ukrajina
- Chiesi Site No 1411
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Beroun, Česko
- Chiesi Site No 201
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Brno, Česko
- Chiesi Site No 206
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Brno, Česko
- Chiesi Site No 207
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Prague, Česko
- Chiesi Site No 202
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Prague, Česko
- Chiesi Site No 203
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Prague, Česko
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Prague, Česko
- Chiesi Site No 205
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Prague, Česko
- Chiesi Site No 208
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Badalona, Španělsko
- Chiesi Site No 1101
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Lleida, Španělsko
- Chiesi Site No 1102
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Terrassa, Španělsko
- Chiesi Site No 1105
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Zaragoza, Španělsko
- Chiesi Site No 1106
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Popis
Kritéria pro zařazení:
- Byl získán písemný podepsaný a datovaný informovaný souhlas.
- Pacienti mužského nebo ženského pohlaví ve věku ≥ 18 let.
- Pozitivní test reverzibility
- Pacienti, kteří prodělali alespoň jednu těžkou exacerbaci během 12 měsíců před vstupem (ale ne v posledním měsíci)
- Použití inhalačních kortikosteroidů (ICS) v monoterapii nebo použití IKS ve fixní nebo volné kombinaci s dlouhodobě působícími beta2 agonisty (LABA) v konstantní dávce po dobu dvou měsíců před screeningovou návštěvou
- Ne plně kontrolovaní astmatici (což znamená částečně kontrolovaní nebo/a nekontrolovaní pacienti podle doporučení GINA 2007) v posledním měsíci před screeningovou návštěvou
- Usilovaný výdechový objem v první sekundě (FEV1) ≥ 60 % předpokládané normální hodnoty pacienta.
- Nekuřáci nebo bývalí kuřáci
Kritéria vyloučení:
- Těhotné nebo kojící (kojící) ženy. Ženy ve fertilním věku, POKUD nesplňují následující definici postmenopauzy: 12 měsíců přirozené (spontánní) amenorey nebo 6 měsíců spontánní amenorey s hladinami FSH v séru > 40 mIU/ml nebo používají jednu nebo více přijatelných metod antikoncepce
- Index tělesné hmotnosti (BMI) > 34 kg/m2.
- Pacient s infekcemi dolních cest dýchacích postihujícími astma pacienta do 30 dnů od screeningové návštěvy.
- Užívání systémových steroidů v posledním měsíci.
- Pacienti s jinými plicními chorobami, jako je CHOPN, cystická fibróza, intersticiální plicní onemocnění nebo jakákoli jiná klinicky nebo funkčně významná plicní porucha.
- Pacienti, kteří mají nekontrolované respirační, hematologické, imunologické, ledvinové, neurologické, jaterní, endokrinní nebo jiné onemocnění.
- Klinicky relevantní laboratorní abnormality
- Pacienti, kteří mají abnormální hodnotu intervalu QTcF
- Nesnášenlivost nebo kontraindikace léčby beta2-agonisty a/nebo IKS nebo alergie na kteroukoli složku studované léčby.
- Pacienti léčení kortikosteroidy s pomalým uvolňováním během 3 měsíců před screeningovou návštěvou.
- Pacienti léčení anti-IgE protilátkami.
- Pacienti léčení fixní kombinací LABA nebo IKS/LABA 24 hodin před screeningovou návštěvou
- Těžká exacerbace astmatu v posledním měsíci před screeningovou návštěvou
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Foster (Treatment A)
Participants received one inhalation of Foster (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI, BID, as maintenance therapy and additional inhalations of Foster (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) as needed in response to symptoms as reliever therapy.
A maximum of 6 inhalations per day was allowed as reliever therapy.
To ensure blinding, participants received inhalations of placebo matching Ventolin as reliever therapy.
Participants received treatment for a duration of 48 weeks.
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Administered via a pressurized metered-dose inhaler
Ostatní jména:
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Aktivní komparátor: Foster + Ventolin (Treatment B)
Participants received one inhalation of Foster (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI, BID, as maintenance therapy and additional inhalations of Ventolin (Salbutamol, 100 μg per metered dose) as needed in response to symptoms as reliever therapy.
A maximum of 6 inhalations per day was allowed as reliever therapy.
To ensure blinding, participants received inhalations of placebo matching Foster as reliever therapy.
Participants received treatment for a duration of 48 weeks.
|
Administered via a pressurized metered-dose inhaler
Ostatní jména:
Administered via a pressurized metered-dose inhaler
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time to First Severe Asthma Exacerbation
Časové okno: From First IMP dose to week 48 (EOT)
|
A severe asthma exacerbation was defined as asthma worsening resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days because of asthma. First severe asthma exacerbation occurred after the first dose of randomised study drug and within end of study was considered for the analysis. Patients without a severe asthma exacerbation or withdrawn before having it, are considered as 'censored' at the last day in the study or at the time of the withdrawal. Since the median time (50th percentile) and the other key percentiles (25th and 75th) were not reached, the median time of first exacerbation is not available (N.A.). So, to provide meaningful information, the cumulative number of patients who experienced a severe exacerbation at the end of each time period was reported separately. |
From First IMP dose to week 48 (EOT)
|
|
Cumulative Number of Patients With Severe Asthma Exacerbation by Inter-visit (Measured in Weeks)
Časové okno: From First dose to end of each interval: 0-4, 4-12, 12-24, 24-36, 36-48 weeks
|
A severe asthma exacerbation was defined as asthma worsening resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days because of asthma. First severe asthma exacerbation occurred after the first dose of randomised study drug and within end of study was considered for the analysis. Patients without a severe asthma exacerbation or withdrawn before having it, are considered as 'censored' at the last day in the study or at the time of the withdrawal. As already anticipated in the primary endpoint, since the median time (50th percentile) and the other key percentiles (25th and 75th) were not reached, and the median time of first exacerbation is not available (N.A.), to provide meaningful information, the cumulative number of patients who experienced a severe exacerbation at the end of each time period is here reported. |
From First dose to end of each interval: 0-4, 4-12, 12-24, 24-36, 36-48 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Severe Asthma Exacerbations Per 100 Patients Per Year
Časové okno: First dose to end of the study (Up to 48 Weeks)
|
A severe asthma exacerbation was defined as asthma worsening, resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days. As per the outcome measure title, the total number of severe exacerbations (this outcome), of hospitalisations/emergency room treatment, of systemic corticosteroids use (other outcomes) is expressed as rate (events per 100 patients per year) and compared between arms. Please note that in case of two close severe asthma exacerbations (start date of a severe asthma exacerbation is less than 10 days from the stop date of the previous severe asthma exacerbation), only the first was counted for the analysis. |
First dose to end of the study (Up to 48 Weeks)
|
|
Number of Systemic Corticosteroids Courses to Treat Asthma Per 100 Patients Per Year
Časové okno: First dose to end of the study (Up to 48 Weeks)
|
Systemic corticosteroids courses to treat asthma started at or after the first dose of randomised study drug and with at least one day from the stop date of a systemic corticosteroids course and the start date of the following one have been considered for analysis.
As per the outcome measure title, the total number of severe exacerbations (other outcome), of hospitalisations/emergency room treatment (other outcome), of systemic corticosteroids use (this outcome) is expressed as rate (events per 100 patients per year) and compared between arms.
|
First dose to end of the study (Up to 48 Weeks)
|
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Number of Hospitalisation/Emergency Room Treatments Due to Asthma Per 100 Patients Per Year
Časové okno: From first dose to end of the study (Up to Week 48)
|
Hospitalization or emergency room treatment due to asthma started at or after the first dose of randomised study drug was be considered for the analysis. As per the outcome measure title, the total number of severe exacerbations (another outcome), of hospitalisations/emergency room treatment (this outcome), of systemic corticosteroids use (other outcomes) is expressed as rate (events per 100 patients per year) and compared between arms. |
From first dose to end of the study (Up to Week 48)
|
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Change From Baseline in Asthma Control Questionnaire (ACQ) Score to Each Visit
Časové okno: Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6), Week 48 (V7)
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The Asthma Control Questionnaire is a tool used to asses how well a participant asthma is controlled and consists of seven questions scored. On average/in general, during the past week 0 (no impairment), 6 (maximum impairment for symptoms).
The ACQ total score has been calculated as the mean of the seven question scores ranging from 0 (totally controlled) and 6 (severely uncontrolled). Higher scores indicate the worse outcomes. Adjusted means were reported. |
Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6), Week 48 (V7)
|
|
Number of Mild Asthma Exacerbations Per 100 Patients / Year
Časové okno: From first dose through end of the study (Up to Week 48)
|
A mild asthma exacerbation was defined as two consecutive mild asthma exacerbation days satisfying the same criterion. In case periods satisfying different criteria overlapping, only one mild asthma exacerbation was considered. In case of two close mild asthma exacerbations (start date of a mild asthma exacerbation is less than 7 days from the stop date of the previous mild asthma exacerbation), only the first was counted for the analysis. Mild asthma exacerbations occurred at or after the first dose of randomised study drug and within end of study is considered for the analysis. As per the outcome measure title, the total number of mild asthma exacerbations is expressed as rate (events per 100 patients per year) and compared between arms. |
From first dose through end of the study (Up to Week 48)
|
|
Number of Mild Asthma Exacerbations: Number of Total Events
Časové okno: From first dose through end of the study (Up to Week 48)
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A mild asthma exacerbation was defined as two consecutive mild asthma exacerbation days satisfying the same criterion. In case periods satisfying different criteria overlapping, only one mild asthma exacerbation was considered. In case of two close mild asthma exacerbations (start date of a mild asthma exacerbation is less than 7 days from the stop date of the previous mild asthma exacerbation), only the first was counted for the analysis. Total number of mild asthma exacerbation events were reported. Mild asthma exacerbations occurred at or after the first dose of randomised study drug and within end of study is considered for the analysis. . |
From first dose through end of the study (Up to Week 48)
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Time to First Mild Asthma Exacerbation
Časové okno: From first dose to end of the study (Up to Week 48)
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A "mild asthma exacerbation" was defined as two consecutive mild asthma exacerbation days satisfying the same criterion. In case periods satisfying different criteria overlapping, only 1 mild exacerbation was considered. In case of two close mild exacerbations (start date of a mild exacerbation is less than 7 days from the stop date of the previous mild exacerbation), only the first was counted for the analysis. First mild exacerbation occurred after the first dose of randomised study drug and within end of study is considered for the analysis. In patient with at least one mild exacerbation, the time to first mild exacerbation was calculated as the time in days between the first dose of randomised study drug (derived) and the time at which the first mild exacerbation occurs (date of the first day of the first mild exacerbation). Time to first mild asthma exacerbation (days) = (date of first day of first mild exacerbation - date of first dose of randomised study drug (derived)) +1 |
From first dose to end of the study (Up to Week 48)
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Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) to Each Visit
Časové okno: Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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PEF is measured twice a day (morning and evening) with Spirotel, a portable electronic peak flow meter.
PEF measurement recorded in the morning of the day of each clinic visit was considered as data of the period before clinic visit.
During each measurement session (morning or evening before the intake of the study medication) the participant performed 3 blows and only the best PEF parameter was saved into the Spirotel memory.
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Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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Change From Baseline in Daily PEF Variability to Each Visit
Časové okno: Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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PEF is measured twice a day (morning and evening) with Spirotel. PEF measurement recorded in the morning of the day of each clinic visit was considered as data of the period before clinic visit. During each measurement session (morning or evening before the intake of the study medication) the participant will perform 3 blows and only the best PEF parameter will be saved into the Spirotel memory. The variability of PEF of a day will be calculated using the Best PEF morning and the Best PEF evening recorded in the same day. Variability of PEF is measured daily with Spirotel using the following formula: Best PEF evening - Best PEF morning/Best PEF evening + Best PEF morning/2 X 100 |
Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Each Visit
Časové okno: Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
FEV1 was measured using spirometry, conducted at baseline and all clinical visits.
An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEV1 values indicate better lung function.
Adjusted means were reported.
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Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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Change From Baseline in Pre-Dose Forced Expiratory Flow Between 25% and 75% of Vital Capacity (FEF25-75%) at Each Visit
Časové okno: Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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FEF is a lung function test and is measured using the spirometery.
The FEF25%-75% is the forced expiratory flow from 25% to 75% of FVC.
FEF25%-75% measurement is conducted at baseline and all clinical visits.
An increase in FEF25%-75% reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEF25%-75% values indicate better lung function.
Adjusted means were reported.
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Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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Change From Baseline in Total Asthma Symptom Scores Measured Daily by Each Visit
Časové okno: Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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The asthma symptoms are: cough, wheeze, chest tightness and breathlessness. Each morning and evening asthma symptoms are to be scored, as respectively occurred during the night and during the day, as follows: Night-time asthma symptom score: 0 = No symptom, 1 = Mild: symptoms not causing awakening, 2 = Moderate: discomfort enough to cause awakening, 3 = Severe: causing awakening for most of the night / do not allow to sleep at all Day-time asthma symptom score: 0 = No symptom, 1 = Mild: aware of symptoms which can be easily tolerated, 2 = Moderate: discomfort enough to cause interference with daily activity, 3 = Severe: incapacitating with inability to work / take part in usual activity Total asthma symptoms score was calculated as the sum of the day-time and the night-time asthma symptoms score recorded on the following day and score ranges from 0 to 6, higher score indicates worse symptoms. |
Baseline, Weeks 4 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7)
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Number of Inhalations of Reliever Medication Per Day by Each Two-Week Period
Časové okno: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12, 13-14, 15-16, 17-18,19-20,21-22, 23-24, 25-26, 27-28, 29-30, 31-32, 33-34, 35-36, 37-38, 39-40, 41-42, 43-44, 45-46, 47-48
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The daily use of reliever medication was calculated as sum of the number of puffs taken during the day and the number of puffs taken during the night recorded on the following day.
In case one session in a day is missing, only the available session (evening or morning) was considered for the daily use of reliever medication.
A minimum of seven evaluable measurements are required in each two-week treatment period and during the two-weeks of the run-in period (baseline).
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Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12, 13-14, 15-16, 17-18,19-20,21-22, 23-24, 25-26, 27-28, 29-30, 31-32, 33-34, 35-36, 37-38, 39-40, 41-42, 43-44, 45-46, 47-48
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Percentage of Asthma Symptom-free Days by Each Two-Week Period
Časové okno: Week 3-4, 11-12, 23-24, 35-36 and 47-48
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Asthma symptom-free days are days with the total asthma symptom score equal to zero. Percentage of asthma symptom-free days will be calculated in each two-week period using the following formula: % of asthma symptoms- free days = Number o f asthma symptoms- free days in that two - week period/Number o f days with data recorded for asthma symptom scores in that two - week period X 100. |
Week 3-4, 11-12, 23-24, 35-36 and 47-48
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Percentage of Reliever-Medication-Free Days by Each Two-Week Period
Časové okno: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12, 13-14, 15-16, 17-18,19-20,21-22, 23-24, 25-26, 27-28, 29-30, 31-32, 33-34, 35-36, 37-38, 39-40, 41-42, 43-44, 45-46, 47-48
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A day without reliever medication is a day in which the number of puffs of reliever medication taken in the 24 hours is zero. A day will be considered as missing if both measurements (evening and morning) are missing. A day will be considered as "not-free" if one session is recorded and the other is missing. Percentage of reliever medication-free days will be calculated in each two-week period using the following formula: % of reliever medication-free days = Number of reliever medication-free days in that two -week period/Number of days with data recorded for reliever medication in that two -week period X 100 |
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12, 13-14, 15-16, 17-18,19-20,21-22, 23-24, 25-26, 27-28, 29-30, 31-32, 33-34, 35-36, 37-38, 39-40, 41-42, 43-44, 45-46, 47-48
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Percentage of Asthma Control Days by Each Two-week Period Before Clinic Visits
Časové okno: Week 3-4, 11-12, 23-24, 35-36 and 47-48
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Asthma control day is a day with total asthma symptom score equal to zero and without use of reliever medication. A day will be considered as missing if both measurements (evening and morning) are missing. A day will be considered as "not control" if one session is recorded and the other is missing. Percentage of asthma control days will be calculated in each two-week period using the following formula: % of asthma control days = Number of asthma control days in that two -week period/Number of days with data recorded for asthma symptom scores and reliever medication in that two-week period X100 |
Week 3-4, 11-12, 23-24, 35-36 and 47-48
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Number of Participants With Treatment Emergent Adverse Events
Časové okno: From first dose of study drug until end of the study (up to 48 weeks)
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AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense. |
From first dose of study drug until end of the study (up to 48 weeks)
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Number of Patients Who Required > 6 Rescue Inhalations Per Day for at Least Two Consecutive Days During During Treatment Period
Časové okno: From first dose of study drug until end of the study (up to 48 weeks)
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Use of reliever medication was derived from the data of SpirotelTM.
The event "more than six reliever medications per day for two consecutive days" is defined as at least two consecutive days with more than six puffs of reliever medication in the day.
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From first dose of study drug until end of the study (up to 48 weeks)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Alberto Papi, Professor, Università degli Studi di Ferrara
Publikace a užitečné odkazy
Obecné publikace
- Papi A, Corradi M, Pigeon-Francisco C, Baronio R, Siergiejko Z, Petruzzelli S, Fabbri LM, Rabe KF. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Mar;1(1):23-31. doi: 10.1016/S2213-2600(13)70012-2. Epub 2013 Mar 4.
- Morjaria JB, Rigby AS, Morice AH. Symptoms and exacerbations in asthma: an apparent paradox? Ther Adv Chronic Dis. 2019 Oct 24;10:2040622319884387. doi: 10.1177/2040622319884387. eCollection 2019.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění imunitního systému
- Nemoci dýchacích cest
- Plicní onemocnění
- Bronchiální onemocnění
- Plicní onemocnění, obstrukční
- Respirační přecitlivělost
- Přecitlivělost, okamžitá
- Přecitlivělost
- Astma
- Organické chemikálie
- Terapeutika
- Polycyklické sloučeniny
- Aminy
- Těhotenství
- Těhotenství
- Steroidy
- Sloučeniny roztaveného kruhu
- Péče o pacienty
- Zdravotní služby
- Zdravotnická zařízení pracovní síla a služby
- Komunitní zdravotnické služby
- Alkoholy
- Těhotenství
- Amino alkoholy
- Ethanolaminy
- Fenylaminy
- Ethylaminy
- Steroidy, chlorované
- Formoterol fumarát
- Albuterol
- Beklomethason
- Pěstounská péče
Další identifikační čísla studie
- CCD-0804-PR-0034
- 2008-004671-22 (Číslo EudraCT)
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