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Undersøgelse for at vurdere PT010 hos voksne og unge deltagere med utilstrækkeligt kontrolleret astma (LOGOS) (LOGOS)

8. juni 2026 opdateret af: AstraZeneca

En randomiseret, dobbeltblindet, dobbelt dummy, parallel gruppe, multicenter-studie med variabel længde for at vurdere effektiviteten og sikkerheden af ​​PT010 i forhold til PT009 og Symbicort® hos voksne og unge deltagere med utilstrækkeligt kontrolleret astma

Dette er et studie med variabel længde til at evaluere effektiviteten og sikkerheden af ​​budesonid/glycopyrronium/formoterol-inhalatoren hos voksne og unge med svær astma, som er utilstrækkeligt kontrolleret med standardbehandling.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er en randomiseret, dobbelt-blind, dobbelt dummy, parallel gruppe, multicenter 24 til 52 uger variabel længde undersøgelse for at vurdere effektiviteten og sikkerheden af ​​budesonid, glycopyrronium og formoterolfumarat inhalator (MDI) i forhold til budesonid og formoterolfumarat MDI og Symbicort® tryksat MDI hos voksne og unge deltagere med utilstrækkeligt kontrolleret astma. Cirka 2200 deltagere vil blive randomiseret globalt.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2187

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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      • Porto Alegre, Brasilien, 90610-000
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  • Colombia
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    • Utah
      • Roy, Utah, Forenede Stater, 84067
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      • Abingdon, Virginia, Forenede Stater, 24210
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      • Milwaukee, Wisconsin, Forenede Stater, 53226
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      • Thessaloniki, Grækenland, 57010
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  • Israel
      • Ashkelon, Israel, 7830604
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      • Kfar Saba, Israel, 4428164
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  • Mexico
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  • Portugal
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      • Lisbon, Portugal, 1649-035
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  • Puerto Rico
      • Ponce, Puerto Rico, 00717
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  • Rusland
      • Chelyabinsk, Rusland, 454106
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  • Slovakiet
      • Bojnice, Slovakiet, 972 01
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      • Durban, Sydafrika, 4001
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      • Johannesburg, Sydafrika, 2001
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  • Tjekkiet
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      • Prague, Tjekkiet, 190 00
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  • Tyrkiet (Türkiye)
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      • Mainz, Tyskland, 55128
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      • München-Pasing, Tyskland, 81241
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      • Witten, Tyskland, 58452
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Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 80 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. 12 til 80 år, mand og kvinde, BMI
  2. Dokumenteret anamnese med lægediagnosticeret astma > og/eller = 1 år før V1.
  3. Regelmæssig brug af et stabilt dagligt ICS/LABA-regimen (inklusive en stabil ICS-dosis) med mellem- til høje ICS-doser i mindst 4 uger før V1.
  4. ACQ-7 samlet score ≥1,5 ved besøg 1, 3 og 5 (præ-randomisering).

  5. FEV1 % (vurderet som et gennemsnit af 60 og 30 minutters før-dosis vurderinger) forudsagt normal ved V1, 2, 3, 4 og 5 (præ-randomisering)

    • Deltagere > og/eller = 18 år: < 80 %
    • Deltagere 12 til

  6. FEV1 post-albuterol ved V2 eller V3 (hvis gentagelse er nødvendig). • Deltagere > og/eller = 18 år: Forøgelse > og/eller = 12 % og > og/eller = 200 ml.

    • Deltagere 12 til
    • Bemærk: Reversibilitetstest er stadig påkrævet ved besøg 2 og/eller besøg 3, selvom patienten har dokumenteret historisk reversibilitet rapporteret i de 12 måneder forud for besøg 1.
  7. Villig og, efter investigators mening, i stand til at justere den nuværende astmabehandling, som krævet af protokollen.
  8. Demonstrere acceptabel MDI/pMDI administrationsteknik.
  9. Modtog ingen astmamedicin udover indkørt BFF MDI BID og albuterol efter behov under screening (undtagen tilladte medicin som defineret i tabel 9 og systemisk kortikosteroid eller ICS til behandling af en astmaforværring).
  10. eDagbog 14-dages overholdelse ≥70 % under screening (defineret som at udfylde den daglige e-dagbog for alle 10 morgener og alle 10 aftener og svare "Ja" til at tage 2 pust indkørt BFF MDI for alle 10 morgener og 10 aftener i de sidste 14 dage før randomisering).
  11. Ingen luftvejsinfektion i de 4 uger før randomisering eller astmaforværring behandlet med systemisk kortikosteroid og/eller yderligere ICS-behandling i de 4 uger før randomisering.

Ekskluderingskriterier:

1. Afsluttet behandling for luftvejsinfektion eller astmaforværring med systemiske kortikosteroider inden for 4 uger efter V1.

2a. Deltagere, hvor behandling med biologisk astmabehandling efter Investigators opfattelse vil være passende.

2b. Eventuelle markedsførte eller eksperimentelle biologiske lægemidler inden for 3 måneder eller 5 halveringstider af V1, alt efter hvad der er længst og må ikke anvendes under undersøgelsens varighed.

3. Nuværende rygere, tidligere rygere med >10 års historie eller tidligere rygere, der holdt op med at ryge

4. Aktuelt bevis for KOL.

5a. Oral og IV kortikosteroidbrug (en hvilken som helst dosis) inden for 4 uger efter V1.

5b. Brug af systemiske kortikosteroider af enhver anden grund bortset fra akut behandling af svær astmaforværring er forbudt i hele undersøgelsens varighed.

5c. Depotkortikosteroidbrug uanset årsag inden for 12 måneder efter V1.

6. Brug af LAMA, enten alene eller som en del af en inhaleret kombinationsbehandling, i de 12 uger før besøg 1.

7. Brug af oral b2-agonist inden for 3 måneder efter V1.

8. Brug af immunmodulatorer eller immunsuppressiv medicin inden for 3 måneder eller 5 halveringstider, alt efter hvad der er længst, og må ikke anvendes under undersøgelsens varighed.

9. Snævervinklet grøn stær ikke behandlet tilstrækkeligt og/eller ændring i synet, som kan være relevant, efter Investigators vurdering, inden for 3 måneder efter besøg 1.

10. Livstruende astma defineret som en historie med betydelige astmaepisoder, der kræver intubation forbundet med hypercapni, respirationsstop, hypoxiske anfald eller astma-relaterede synkopale episoder.

11. Hospitalsindlæggelse for astma inden for 2 måneder efter besøg 1.

12. Kendt historie med stof- eller alkoholmisbrug inden for 12 måneder efter besøg 1.

13. Regelmæssig brug af en forstøver eller en hjemmeforstøver til modtagelse af astmamedicin.

14. Brug af urteprodukter ved inhalation eller forstøver inden for 4 uger efter besøg 1 og accepterer ikke at stoppe under undersøgelsens varighed.

15. Deltagelse i en anden klinisk undersøgelse med et undersøgelsesprodukt.

16. Deltagere med kendt overfølsomhed over for beta2-agonister, kortikosteroider, antikolinergika eller en hvilken som helst komponent i MDI eller pMDI.

17. Undersøgelsesefterforskere, underforskere, koordinatorer og deres ansatte eller nærmeste familiemedlemmer.

18. Kun for kvinder - i øjeblikket gravide (bekræftet med positiv meget følsom graviditetstest), ammende eller planlagt graviditet under undersøgelsen eller ikke bruger acceptable præventionsforanstaltninger, som vurderet af investigator.

Se venligst undersøgelsesprotokollen for den komplette liste over inklusions- og eksklusionskriterier

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Budesonid, glycopyrronium og formoterolfumarat (BGF) MDI 320/28,8/9,6 μg
BGF MDI 320/28,8/9,6 μg Budesonid, glycopyrronium og formoterolfumarat (PT010) Doseringsinhalator (MDI)
Medicin: BGF MDI 320/28,8/9,6 μg
Budesonid, glycopyrronium og formoterolfumarat afmålt dosisinhalator
Andre navne:
  • BGF
Eksperimentel: BGF MDI 320/14,4/9,6 μg
BGF MDI 320/14,4/9,6 μg Budesonid, glycopyrronium og formoterolfumarat (PT010) Doseringsinhalator (MDI)
Medicin: BGF MDI 320/14,4/9,6 μg
Budesonid, glycopyrronium og formoterolfumarat afmålt dosisinhalator
Andre navne:
  • BGF
Aktiv komparator: Budesonid og formoterolfumarat (BFF) MDI 320/9,6 μg
BFF MDI 320/9,6 μg (eksperimentel/sammenligningsmiddel) Budesonid og formoterolfumarat (PT009) Inhalator til afmålt dosis (MDI)
Medicin: BFF MDI 320/9,6 μg
Budesonid og formoterolfumarat afmålt dosisinhalator
Andre navne:
  • BFF
Aktiv komparator: Symbicort®
Budesonid/formoterolfumarat tryksat afmålt dosisinhalator (pMDI) 320/9 μg
Medicin: BFF pMDI 320/9 μg
Budesonid/formoterolfumarat tryksat afmålt dosisinhalator
Andre navne:
  • Symbicort®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in FEV1 AUC0-3 (L) at Week 24
Tidsramme: Week 24
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations
Tidsramme: Up to 52 Weeks
Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24
Tidsramme: Week 24
Change from baseline in morning pre-dose trough FEV1 at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1
Tidsramme: Day 1
Onset of action on Day 1: Absolute change in FEV1 (L) at 5 minutes on Day 1. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Day 1
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]) +12 (≥0.5 increase equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline
Tidsramme: Up to 52 Weeks
Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤55% at baseline was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1
Tidsramme: Up to 52 Weeks
Rate of severe asthma exacerbations for participants with ≥1 severe exacerbation in the 12 months prior to Visit 1 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks
Pooled (LOGOS/KALOS): Time to First Severe Asthma Exacerbation
Tidsramme: Up to 52 weeks
Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 weeks
Pooled (LOGOS/KALOS): Rate of Moderate or Severe Asthma Exacerbations
Tidsramme: Up to 52 Weeks
Rate of moderate/severe exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate exacerbation was a worsening of symptoms that resulted in additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks
Pooled (LOGOS/KALOS): Time to First Moderate or Severe Asthma Exacerbation
Tidsramme: Up to 52 weeks
Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first moderate or severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first moderate/severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 weeks
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in AQLQ(s) +12 (≥0.5 increase equals response) at Week 24 was assessed in a pre- specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Ledende efterforsker: Robert Wise, MD, Johns Hopkins University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2021

Primær færdiggørelse (Faktiske)

20. marts 2025

Studieafslutning (Faktiske)

20. marts 2025

Datoer for studieregistrering

Først indsendt

26. oktober 2020

Først indsendt, der opfyldte QC-kriterier

26. oktober 2020

Først opslået (Faktiske)

30. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D5982C00008
  • 2020-001521-31 (EudraCT nummer)
  • 2023-505786-88 (Registry Identifier: CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til anonymiserede individuelle data på patientniveau fra AstraZeneca gruppe af virksomheder sponsoreret kliniske forsøg via anmodningsportalen. Alle anmodninger vil blive evalueret i henhold til AZ-offentliggørelsesforpligtelsen: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD-delingstidsramme

AstraZeneca vil opfylde eller overgå datatilgængeligheden i henhold til forpligtelserne i henhold til EFPIA Pharmas datadelingsprincipper. For detaljer om vores tidslinjer henvises til vores offentliggørelsesforpligtelse på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD-delingsadgangskriterier

Når en anmodning er blevet godkendt, giver AstraZeneca adgang til de afidentificerede individuelle data på patientniveau i et godkendt sponsoreret værktøj. Underskrevet datadelingsaftale (ikke-omsættelig kontrakt for dataadgangere) skal være på plads, før du får adgang til de ønskede oplysninger. Derudover skal alle brugere acceptere vilkårene og betingelserne for SAS MSE for at få adgang. For yderligere detaljer, bedes du læse oplysningserklæringerne på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med BGF MDI 320/28,8/9,6 μg

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner