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POTRÓJNE W ASTYCE WYSOKA SIŁA W KONTRA IKACH/LABA HS I tiotRopium (TRIGGER) (TRIGGER)

4 maja 2026 zaktualizowane przez: Chiesi Farmaceutici S.p.A.

52-TYGODNIOWE, RÓWNOLEGŁE BADANIE GRUPOWE Z PODWÓJNĄ ŚLEPĄ, MIĘDZYNARODOWE, WIELONARODOWE, KONTROLOWANE AKTYWNIE, 3-RAMIENNE, RÓWNOLEGŁE PORÓWNANIE CHF 5993 200/6/12,5 µg pMDI (STAŁA KOMBINACJA BARDZO Drobnego Dipropionianu Beklometazonu PLUS FORMOTEROL FUMARAN PLUS GLIKOPIRON TOIUM BROMEK 152053) /6 µg pMDI (STAŁA KOMBINACJA BARDZO Drobnego Dipropionianu Beklometazonu PLUS FUMARANU FORMOTEROLU) SAMODZIELNIE LUB NA OPAKOWANYM TIOTROPIUM 2,5 µg RESPIMAT® U PACJENTÓW Z NIEKONTROLOWANĄ ASTMĄ PODCZAS WYSOKICH DAWEK KORTYKOSTEROIDÓW WDYCHANYCH W POŁĄCZENIU Z DŁUGO DZIAŁAJĄCYMI ß2-AGONISTAMI

Celem tego badania jest ocena wyższości CHF 5993 200/6/12,5 µg pMDI (ustalona kombinacja bardzo drobnego dipropionianu beklometazonu plus fumaran formoterolu i bromek glikopironium) w porównaniu z CHF 1535 200/6 µg pMDI (ustalona kombinacja bardzo drobnego dipropionianu beklometazonu i fumaranu formoterolu) oraz porównanie wpływu CHF 5993 200/6/12,5 µg pMDI vs CHF 5993 200/6/12,5 µg plus Tiotropium 2,5 µg metodą otwartej próby, pod kątem parametrów funkcji płuc i częstości zaostrzeń, a także oceny jego bezpieczeństwa i niektórych wyników ekonomiki zdrowia.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

This was a phase III, multicentre, randomised, double-blind study, with an open-label arm, active-controlled, 3-arm parallel group study to demonstrate both the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose FEV1 at Week 26 and a reduction of moderate and severe asthma exacerbation rate with CHF 5993 pMDI 200/6/12.5 μg compared to CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The study was performed in patients with uncontrolled asthma on high doses of inhaled corticosteroids (ICS) in combination with long acting β2-agonists LABAs). The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and all other requirements of local laws.

Patients completed the electronic diary (eDiary)/electronic peak flow meter (ePeakflowmeter) twice daily at home from screening to Week 52, recording asthma symptoms, treatment compliance, rescue intake and peak expiratory flow (PEF). The Asthma Control Questionnaire© (ACQ)-7 was completed at all visits from screening to Week 52. The EuroQuality of Life-5-Dimensional-3-Level (EQ-5D-3L™) questionnaire was completed at all visits from randomisation to Week 52. Health economic information was collected during the study. An independent Data Safety Monitoring Board was established for evaluation of the study and impartial safety assurance for patients. An Adjudication Committee was established to evaluate Major Adverse Cardiovascular Events.

Primary objective of the study were:

  • To demonstrate the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose forced expiratory volume in the 1st second (FEV1) at Week 26;
  • To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The secondary endpoints included pooled analyse of 2 pivotal studies; this study (TRIGGER) and study (TRIMARAN). These 2 studies have similar study designs and study population.

CHF 1535 pMDI: fixed-dose combination (FDC) of BDP + FF + GB Dose: BDP 200 μg, FF 6 μg, GB 12.5 μg per actuation, 2 inhalations, BID. Total daily dose: BDP 800 μg, FF 24 μg, GB 50 μg.

BDP: Beclometasone dipropionate FF: Formoterol fumarate GB: Glycopyrronium bromide

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1437

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna
        • Chiesi Clinical Trial Site 432702
      • CABA, Argentyna
        • Chiesi Clinical Trial Site 432704
      • Mar del Plata, Argentyna
        • Chiesi Clinical Trial Site 432705
      • Quilmes, Argentyna
        • Chiesi Clinical Trial Site 432701
      • San Miguel de Tucumán, Argentyna
        • Chiesi Clinical Trial Site 432703
      • San Miguel de Tucumán, Argentyna
        • Chiesi Clinical Trial Site 432706
  • Białoruś
      • Homyel, Białoruś
        • Chiesi Clinical Trial Site 112703
      • Homyel, Białoruś
        • Chiesi Clinical Trial Site 112704
      • Minsk, Białoruś
        • Chiesi Clinical Trial Site 112701
      • Minsk, Białoruś
        • Chiesi Clinical Trial Site 112702
      • Minsk, Białoruś
        • Chiesi Clinical Trial Site 112705
  • Bułgaria
      • Blagoevgrad, Bułgaria
        • Chiesi Clinical Trial Site 100707
      • Burgas, Bułgaria
        • Chiesi Clinical Trial Site 100720
      • Gabrovo, Bułgaria
        • Chiesi Clinical Trial Site 100718
      • Haskovo, Bułgaria
        • Chiesi Clinical Trial Site 100713
      • Montana, Bułgaria
        • Chiesi Clinical Trial Site 100722
      • Pleven, Bułgaria
        • Chiesi Clinical Trial Site 100702
      • Plovdiv, Bułgaria
        • Chiesi Clinical Trial Site 100705
      • Plovdiv, Bułgaria
        • Chiesi Clinical Trial Site 100708
      • Plovdiv, Bułgaria
        • Chiesi Clinical Trial Site 100715
      • Rousse, Bułgaria
        • Chiesi Clinical Trial Site 100716
      • Sofia, Bułgaria
        • Chiesi Clinical Trial Site 100701
      • Sofia, Bułgaria
        • Chiesi Clinical Trial Site 100703
      • Sofia, Bułgaria
        • Chiesi Clinical Trial Site 100704
      • Sofia, Bułgaria
        • Chiesi Clinical Trial Site 100709
      • Sofia, Bułgaria
        • Chiesi Clinical Trial Site 100719
      • Stara Zagora, Bułgaria
        • Chiesi Clinical Trial Site 100706
      • Stara Zagora, Bułgaria
        • Chiesi Clinical Trial Site 100712
      • Varna, Bułgaria
        • Chiesi Clinical Trial Site 100710
      • Vidin, Bułgaria
        • Chiesi Clinical Trial Site 100711
      • Vidin, Bułgaria
        • Chiesi Clinical Trial Site 100721
  • Czechy
      • Blansko, Czechy
        • Chiesi Clinical Trial Site 203711
      • Brandýs nad Labem, Czechy
        • Chiesi Clinical Trial Site 203702
      • Brno, Czechy
        • Chiesi Clinical Trial Site 203708
      • Jindřichův Hradec, Czechy
        • Chiesi Clinical Trial Site 203707
      • Kralupy nad Vltavou, Czechy
        • Chiesi Clinical Trial Site 203705
      • Miroslav, Czechy
        • Chiesi Clinical Trial Site 203709
      • Opava, Czechy
        • Chiesi Clinical Trial Site 203704
      • Prague, Czechy
        • Chiesi Clinical Trial Site 203701
      • Prague, Czechy
        • Chiesi Clinical Trial Site 203703
      • Prague, Czechy
        • Chiesi Clinical Trial Site 203710
      • Rokycany, Czechy
        • Chiesi Clinical Trial Site 203713
      • Teplice, Czechy
        • Chiesi Clinical Trial Site 203706
      • Varnsdorf, Czechy
        • Chiesi Clinical Trial Site 203712
  • Hiszpania
      • A Coruña, Hiszpania
        • Chiesi Clinical Trial Site 724702
      • Badajoz, Hiszpania
        • Chiesi Clinical Trial Site 724703
      • Badalona, Hiszpania
        • Chiesi Clinical Trial Site 724706
      • Madrid, Hiszpania
        • Chiesi Clinical Trial Site 724701
      • Madrid, Hiszpania
        • Chiesi Clinical Trial Site 724704
      • Málaga, Hiszpania
        • Chiesi Clinical Trial Site 724705
      • Sabadell, Hiszpania
        • Chiesi Clinical Trial Site 724707
  • Litwa
      • Vilnius, Litwa
        • Chiesi Clinical Trial Site 440702
      • Vilnius, Litwa
        • Chiesi Clinical Trial Site 440703
      • Vilnius, Litwa
        • Chiesi Clinical Trial Site 440705
      • Šiauliai, Litwa
        • Chiesi Clinical Trial Site 440701
  • Niemcy
      • Berlin, Niemcy
        • Chiesi Clinical Trial Site 276709
      • Berlin, Niemcy
        • Chiesi Clinical Trial Site 276712
      • Bonn, Niemcy
        • Chiesi Clinical Trial Site 276711
      • Frankfurt am Main, Niemcy
        • Chiesi Clinical Trial Site 276707
      • Frankfurt am Main, Niemcy
        • Chiesi Clinical Trial Site 276714
      • Hamburg, Niemcy
        • Chiesi Clinical Trial Site 276705
      • Hanover, Niemcy
        • Chiesi Clinical Trial Site 276703
      • Koblenz, Niemcy
        • Chiesi Clinical Trial Site 276708
      • Leipzig, Niemcy
        • Chiesi Clinical Trial Site 276702
      • Leipzig, Niemcy
        • Chiesi Clinical Trial Site 276704
      • Leipzig, Niemcy
        • Chiesi Clinical Trial Site 276710
      • Mainz, Niemcy
        • Chiesi Clinical Trial Site 276715
      • München, Niemcy
        • Chiesi Clinical Trial Site 276701
      • Münster, Niemcy
        • Chiesi Clinical Trial Site 276713
      • Rosenheim, Niemcy
        • Chiesi Clinical Trial Site 276716
  • Polska
      • Bialystok, Polska
        • Chiesi Clinical Trial Site 616713
      • Bialystok, Polska
        • Chiesi Clinical Trial Site 616718
      • Bielsko-Biala, Polska
        • Chiesi Clinical Trial Site 616722
      • Bienkówka, Polska
        • Chiesi Clinical Trial Site 616702
      • Bydgoszcz, Polska
        • Chiesi Clinical Trial Site 616727
      • Giżycko, Polska
        • Chiesi Clinical Trial Site 616704
      • Grudziądz, Polska
        • Chiesi Clinical Trial Site 616716
      • Katowice, Polska
        • Chiesi Clinical Trial Site 616725
      • Katowice, Polska
        • Chiesi Clinical Trial Site 616729
      • Krakow, Polska
        • Chiesi Clinical Trial Site 616719
      • Krakow, Polska
        • Chiesi Clinical Trial Site 616734
      • Krakow, Polska
        • Chiesi Clinical Trial Site 616736
      • Lodz, Polska
        • Chiesi Clinical Trial Site 616707
      • Lodz, Polska
        • Chiesi Clinical Trial Site 616708
      • Lodz, Polska
        • Chiesi Clinical Trial Site 616711
      • Lodz, Polska
        • Chiesi Clinical Trial Site 616726
      • Mrozy, Polska
        • Chiesi Clinical Trial Site 616733
      • Ostróda, Polska
        • Chiesi Clinical Trial Site 616717
      • Otwock, Polska
        • Chiesi Clinical Trial Site 616731
      • Pabianice, Polska
        • Chiesi Clinical Trial Site 616703
      • Poznan, Polska
        • Chiesi Clinical Trial Site 616709
      • Poznan, Polska
        • Chiesi Clinical Trial Site 616728
      • Proszowice, Polska
        • Chiesi Clinical Trial Site 616720
      • Rzeszów, Polska
        • Chiesi Clinical Trial Site 616723
      • Rzeszów, Polska
        • Chiesi Clinical Trial Site 616735
      • Skierniewice, Polska
        • Chiesi Clinical Trial Site 616721
      • Strzelce Opolskie, Polska
        • Chiesi Clinical Trial Site 616732
      • Tarnów, Polska
        • Chiesi Clinical Trial Site 616710
      • Warsaw, Polska
        • Chiesi Clinical Trial Site 616701
      • Wilkowice, Polska
        • Chiesi Clinical Trial Site 616730
      • Wroclaw, Polska
        • Chiesi Clinical Trial Site 616705
      • Wroclaw, Polska
        • Chiesi Clinical Trial Site 616714
      • Wroclaw, Polska
        • Chiesi Clinical Trial Site 616715
      • Świdnik, Polska
        • Chiesi Clinical Trial Site 616712
  • Portugalia
      • Aveiro, Portugalia
        • Chiesi Clinical Trial Site 620704
      • Figueira da Foz Municipality, Portugalia
        • Chiesi Clinical Trial Site 620703
      • Lisbon, Portugalia
        • Chiesi Clinical Trial Site 620702
      • Loures, Portugalia
        • Chiesi Clinical Trial Site 620708
      • Vila Nova de Gaia, Portugalia
        • Chiesi Clinical Trial Site 620707
  • Rosja
      • Chelyabinsk, Rosja
        • Chiesi Clinical Trial Site 643727
      • Chelyabinsk, Rosja
        • Chiesi Clinical Trial Site 643733
      • Chelyabinsk, Rosja
        • Chiesi Clinical Trial Site 643745
      • Izhevsk, Rosja
        • Chiesi Clinical Trial Site 643754
      • Kazan', Rosja
        • Chiesi Clinical Trial Site 643713
      • Kazan', Rosja
        • Chiesi Clinical Trial Site 643719
      • Kazan', Rosja
        • Chiesi Clinical Trial Site 643741
      • Kazan', Rosja
        • Chiesi Clinical Trial Site 643746
      • Kemerovo, Rosja
        • Chiesi Clinical Trial Site 643704
      • Kemerovo, Rosja
        • Chiesi Clinical Trial Site 643731
      • Moscow, Rosja
        • Chiesi Clinical Trial Site 643702
      • Moscow, Rosja
        • Chiesi Clinical Trial Site 643705
      • Moscow, Rosja
        • Chiesi Clinical Trial Site 643706
      • Moscow, Rosja
        • Chiesi Clinical Trial Site 643718
      • Moscow, Rosja
        • Chiesi Clinical Trial Site 643722
      • Moscow, Rosja
        • Chiesi Clinical Trial Site 643735
      • Moscow, Rosja
        • Chiesi Clinical Trial Site 643743
      • Nizhny Novgorod, Rosja
        • Chiesi Clinical Trial Site 643707
      • Nizhny Novgorod, Rosja
        • Chiesi Clinical Trial Site 643723
      • Nizhny Novgorod, Rosja
        • Chiesi Clinical Trial Site 643744
      • Novosibirsk, Rosja
        • Chiesi Clinical Trial Site 643717
      • Odintsovo, Rosja
        • Chiesi Clinical Trial Site 643724
      • Orenburg, Rosja
        • Chiesi Clinical Trial Site 643729
      • Pyatigorsk, Rosja
        • Chiesi Clinical Trial Site 643711
      • Ryazan, Rosja
        • Chiesi Clinical Trial Site 643701
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643712
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643714
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643715
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643716
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643725
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643730
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643732
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643737
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643739
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643752
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643757
      • Saint Petersburg, Rosja
        • Chiesi Clinical Trial Site 643758
      • Saratov, Rosja
        • Chiesi Clinical Trial Site 643703
      • Saratov, Rosja
        • Chiesi Clinical Trial Site 643736
      • Smolensk, Rosja
        • Chiesi Clinical Trial Site 643726
      • Stavropol, Rosja
        • Chiesi Clinical Trial Site 643740
      • Tomsk, Rosja
        • Chiesi Clinical Trial Site 643709
      • Tomsk, Rosja
        • Chiesi Clinical Trial Site 643728
      • Tomsk, Rosja
        • Chiesi Clinical Trial Site 643759
      • Ufa, Rosja
        • Chiesi Clinical Trial Site 643755
      • Vladikavkaz, Rosja
        • Chiesi Clinical Trial Site 643708
      • Vladimir, Rosja
        • Chiesi Clinical Trial Site 643738
      • Voronezh, Rosja
        • Chiesi Clinical Trial Site 643710
      • Yaroslavl, Rosja
        • Chiesi Clinical Trial Site 643720
      • Yaroslavl, Rosja
        • Chiesi Clinical Trial Site 643734
      • Yaroslavl, Rosja
        • Chiesi Clinical Trial Site 643742
      • Yaroslavl, Rosja
        • Chiesi Clinical Trial Site 643749
      • Yekaterinburg, Rosja
        • Chiesi Clinical Trial Site 643721
  • Rumunia
      • Alexandru cel Bun, Rumunia
        • Chiesi Clinical Trial Site 642715
      • Arad, Rumunia
        • Chiesi Clinical Trial Site 642713
      • Bacau, Rumunia
        • Chiesi Clinical Trial Site 642722
      • Bragadiru, Rumunia
        • Chiesi Clinical Trial Site 642717
      • Brasov, Rumunia
        • Chiesi Clinical Trial Site 642706
      • Bucharest, Rumunia
        • Chiesi Clinical Trial Site 642703
      • Bucharest, Rumunia
        • Chiesi Clinical Trial Site 642707
      • Bucharest, Rumunia
        • Chiesi Clinical Trial Site 642708
      • Bucharest, Rumunia
        • Chiesi Clinical Trial Site 642719
      • Bucharest, Rumunia
        • Chiesi Clinical Trial Site 642723
      • Cluj-Napoca, Rumunia
        • Chiesi Clinical Trial Site 642709
      • Cluj-Napoca, Rumunia
        • Chiesi Clinical Trial Site 642714
      • Cluj-Napoca, Rumunia
        • Chiesi Clinical Trial Site 642716
      • Cluj-Napoca, Rumunia
        • Chiesi Clinical Trial Site 642718
      • Cluj-Napoca, Rumunia
        • Chiesi Clinical Trial Site 642726
      • Craiova, Rumunia
        • Chiesi Clinical Trial Site 642712
      • Iași, Rumunia
        • Chiesi Clinical Trial Site 642704
      • Iași, Rumunia
        • Chiesi Clinical Trial Site 642710
      • Oradea, Rumunia
        • Chiesi Clinical Trial Site 642705
      • Suceava, Rumunia
        • Chiesi Clinical Trial Site 642711
      • Timișoara, Rumunia
        • Chiesi Clinical Trial Site 642721
  • Słowacja
      • Bratislava, Słowacja
        • Chiesi Clinical Trial Site 703704
      • Bratislava, Słowacja
        • Chiesi Clinical Trial Site 703707
      • Ilava, Słowacja
        • Chiesi Clinical Trial Site 703702
      • Košice, Słowacja
        • Chiesi Clinical Trial Site 703705
      • Košice, Słowacja
        • Chiesi Clinical Trial Site 703706
      • Nové Zámky, Słowacja
        • Chiesi Clinical Trial Site 703701
      • Prievidza, Słowacja
        • Chiesi Clinical Trial Site 703709
      • Spišská Nová Ves, Słowacja
        • Chiesi Clinical Trial Site 703703
      • Štúrovo, Słowacja
        • Chiesi Clinical Trial Site 703708
  • Turcja (Türkiye)
      • Ankara, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792701
      • Ankara, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792702
      • Antalya, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792703
      • Aydin, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792710
      • Istanbul, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792707
      • Kocaeli, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792706
      • Maltepe, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792705
      • Mersin, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792708
      • Yenişehir, Turcja (Türkiye)
        • Chiesi Clinical Trial Site 792709
  • Ukraina
      • Dnipro, Ukraina
        • Chiesi Clinical Trial Site 804701
      • Ivano-Frankivsk, Ukraina
        • Chiesi Clinical Trial Site 804711
      • Kharkiv, Ukraina
        • Chiesi Clinical Trial Site 804709
      • Kherson, Ukraina
        • Chiesi Clinical Trial Site 804710
      • Kiev, Ukraina
        • Chiesi Clinical Trial Site 804713
      • Kyiv, Ukraina
        • Chiesi Clinical Trial Site 804705
      • Lviv, Ukraina
        • Chiesi Clinical Trial Site 804712
      • Sumy, Ukraina
        • Chiesi Clinical Trial Site 804715
      • Vinnytsia, Ukraina
        • Chiesi Clinical Trial Site 804703
      • Vinnytsia, Ukraina
        • Chiesi Clinical Trial Site 804706
      • Vinnytsia, Ukraina
        • Chiesi Clinical Trial Site 804707
      • Vinnytsia, Ukraina
        • Chiesi Clinical Trial Site 804714
      • Zaporizhzhya, Ukraina
        • Chiesi Clinical Trial Site 804704
      • Zhytomyr, Ukraina
        • Chiesi Clinical Trial Site 804708
  • Węgry
      • Balassagyarmat, Węgry
        • Chiesi Clinical Trial Site 348707
      • Budapest, Węgry
        • Chiesi Clinical Trial Site 348715
      • Debrecen, Węgry
        • Chiesi Clinical Trial Site 348721
      • Gödöllő, Węgry
        • Chiesi Clinical Trial Site 348712
      • Hatvan, Węgry
        • Chiesi Clinical Trial Site 348718
      • Komárom, Węgry
        • Chiesi Clinical Trial Site 348717
      • Létavértes, Węgry
        • Chiesi Clinical Trial Site 348709
      • Monor, Węgry
        • Chiesi Clinical Trial Site 348703
      • Mórahalom, Węgry
        • Chiesi Clinical Trial Site 348719
      • Nyíregyháza, Węgry
        • Chiesi Clinical Trial Site 348704
      • Nyíregyháza, Węgry
        • Chiesi Clinical Trial Site 348714
      • Pécs, Węgry
        • Chiesi Clinical Trial Site 348713
      • Pécs, Węgry
        • Chiesi Clinical Trial Site 348720
      • Siófok, Węgry
        • Chiesi Clinical Trial Site 348702
      • Szarvas, Węgry
        • Chiesi Clinical Trial Site 348706
      • Szeged, Węgry
        • Chiesi Clinical Trial Site 348701
      • Szombathely, Węgry
        • Chiesi Clinical Trial Site 348705
      • Vásárosnamény, Węgry
        • Chiesi Clinical Trial Site 348710
      • Érd, Węgry
        • Chiesi Clinical Trial Site 348708
  • Włochy
      • Bologna, Włochy
        • Chiesi Clinical Trial Site 380704
      • Catania, Włochy
        • Chiesi Clinical Trial Site 380703
      • Genova, Włochy
        • Chiesi Clinical Trial Site 380701
      • Palermo, Włochy
        • Chiesi Clinical Trial Site 380705
      • Pavia, Włochy
        • Chiesi Clinical Trial Site 380702
      • Tradate, Włochy
        • Chiesi Clinical Trial Site 380706
  • Zjednoczone Królestwo
      • Llanelli, Zjednoczone Królestwo
        • Chiesi Clinical Trial Site 826702
      • London, Zjednoczone Królestwo
        • Chiesi Clinical Trial Site 826703
      • Manchester, Zjednoczone Królestwo
        • Chiesi Clinical Trial Site 826704
      • Soham, Zjednoczone Królestwo
        • Chiesi Clinical Trial Site 826701

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Historia astmy ≥ 1 rok i zdiagnozowana przed 40 rokiem życia
  • Niekontrolowana astma z podwójną terapią tylko dużymi dawkami wziewnego kortykosteroidu (ICS) w połączeniu z długo działającym beta2 agonistą (LABA) z ACQ-7 (kwestionariusz kontroli astmy) ≥1,5
  • FEV1 przed podaniem leku rozszerzającego oskrzela <80% wartości należnej normy
  • Pozytywny test odwracalności
  • Co najmniej 1 udokumentowane zaostrzenie astmy w poprzednim roku

Kryteria wyłączenia:

  • Kobiety w ciąży lub karmiące piersią
  • Diagnostyka przewlekłej obturacyjnej choroby płuc (POChP)
  • Pacjenci z jakimkolwiek zaostrzeniem astmy lub infekcją dróg oddechowych w ciągu 4 tygodni przed badaniem przesiewowym
  • Obecny palacz lub były palacz (>= 10 paczek rocznie)
  • Jakakolwiek zmiana dawki, schematu lub preparatu kombinacji ICS + LABA w ciągu 4 tygodni poprzedzających badanie przesiewowe

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: CHF 5993 200/6/12,5 µg

Leczenie A:

5993 CHF 200/6/12,5 µg: 2 inhalacje 2 razy na dobę Całkowita dawka dobowa: 800/24/50 µg BDP/FF/GB
Lek: CHF 5993 200/6/12,5 µg
Aktywny komparator: CHF 1535 200/6 µg

Leczenie B:

CHF 1535 200/6 µg: 2 inhalacje 2 razy dziennie Całkowita dawka dobowa: 800/24 ​​µg BDP/FF
Lek: CHF 1535 200/6 µg
Aktywny komparator: CHF 1535 200/6 µg + Tiotropium Respimat 2,5 µg

Leczenie C (ramię badania otwartego):

CHF 1535 200/6 µg: 2 inhalacje licytowane

+ Tiotropium Respimat 2,5 µg: 2 inhalacje od Całkowita dawka dobowa: 800/24 ​​µg BDP/FF + 5 µg Tio
Lek: CHF 1535 200/6 µg + Tiotropium Respimat 2,5 µg

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in pre-dose FEV1, analysed at Week 26 of treatment.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26.
2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Asthma exacerbation intensity: Moderate AND Severe Asthma Exacerbation

Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations).

Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
Ramy czasowe: Week 0 (pre-treatment, baseline) and Week 26.

Peak peak of forced expiratory volume in the first second (FEV1) within 3 hours post-dose.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) and Week 26.
4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in the average morning PEF (Litre/min), measured by patients at home over the 26-week treatment period (i.e., up to Week 26).

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26.
5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
Ramy czasowe: The entire treatment period; up to Week 52.

Severe asthma exacerbation rate over the 52-Week treatment period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
The entire treatment period; up to Week 52.
6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

The peak (0-3h) FEV1 at baseline and at all subsequent visits, and the respective changes from baseline are presented by treatment group for all clinical visits.

Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in pre-dose FEV1 at all clinical visits.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the percentage of patients classified as FEV1 responders at Week 26 and at Week 52.

The FEV1 response was defined as: Change from baseline in pre-dose morning FEV1 ≥ 100 mL.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2).

Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose).

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

ACQ-7 Questionnaire.

ACQ-7 allows assessment of asthma control in individual patients.

The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer.

Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function.
Week 0 (pre-treatment, baseline) to Week 52.
11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above.

An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data.

Results represent responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and at Week 52.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
12_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 52.
12a_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Number of patients at risk of a moderate or severe asthma exacerbation.

Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period.
Week 0 (pre-treatment, baseline) to Week 52.
14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Ramy czasowe: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of patients at risk of a SEVERE asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER), over the 52 weeks treatment period.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
Ramy czasowe: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

MODERATE asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Ramy czasowe: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
Ramy czasowe: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Moderate AND severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Ramy czasowe: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Time to first MODERATE OR SEVERE asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

MODERATE asthma exacerbation rate over the 52-Week treatment period.

Asthma exacerbation intensity: Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.
Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
Week 0 (pre-treatment, baseline) to Week 52.
21_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
21a_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
22_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of rescue medication-free days over the 26- and 52-Week treatment periods.

Data was collected using an electronic daily diary, from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
22a_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
23_Change From Baseline in the Average Total Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
23a_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 52.
24_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment.

Data was collected through an electronic daily diary from screening to end of the study.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 52.
25_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could 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).
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
25a_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
Ramy czasowe: Week 0 (pre-treatment, baseline) to Week 52.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could 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).
Week 0 (pre-treatment, baseline) to Week 52.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Zdarzenia niepożądane i niepożądane reakcje na leki
Ramy czasowe: Do tygodnia 52
Do tygodnia 52
Zbiór wyników ekonomii zdrowia
Ramy czasowe: Tydzień 0 do Tydzień 52
Całkowite wykorzystanie zasobów opieki zdrowotnej i nieobecności w pracy
Tydzień 0 do Tydzień 52

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Chiesi Farmaceutici S.p.A.

Śledczy

  • Główny śledczy: Georgio Walter Canonica, MD, University of Medicine, Genoa, Italy

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 kwietnia 2016

Zakończenie podstawowe (Rzeczywisty)

28 maja 2018

Ukończenie studiów (Rzeczywisty)

28 maja 2018

Daty rejestracji na studia

Pierwszy przesłany

3 lutego 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 lutego 2016

Pierwszy wysłany (Szacowany)

8 lutego 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CCD-05993AB2-02
  • 2015-000717-40 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Chiesi zobowiązuje się do udostępniania wykwalifikowanym naukowcom i naukowcom medycznym, prowadzącym legalne badania, Danych na poziomie pacjenta, Danych na poziomie badania, Protokołu klinicznego i pełnego CSR, zapewniając dostęp do informacji z badania klinicznego zgodnie z zasadą ochrony poufnych informacji handlowych i pacjentów Prywatność. Wszelkie udostępniane dane na poziomie pacjenta są anonimizowane w celu ochrony danych osobowych.

Kryteria dostępu Chiesi i pełny proces udostępniania danych klinicznych są dostępne na stronie internetowej Grupy Chiesi.

Ramy czasowe udostępniania IPD

See information above in Plan Description regarding Chiesi's commitment to share information with qualified scientific and medical researchers, conducting legitimate research

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Kryteria dostępu do udostępniania IPD

Kryteria dostępu Chiesi i pełny proces udostępniania danych klinicznych są dostępne na stronie internetowej Grupy Chiesi.

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na CHF 5993 200/6/12,5 µg

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