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Roflumilast eller Azithromycin for at forhindre KOL-eksacerbationer (RELIANCE) (RELIANCE)

6. juli 2026 opdateret af: Johns Hopkins University
Et multicenter, randomiseret, 36-måneders, parallel-gruppe, non-inferiority, fase III-studie for at sammenligne effektiviteten af ​​roflumilast (Daliresp, 500 mcg quaque die (QD) eller alternativ regime) versus azithromycin (250 mg qD, 500 mg én gang dagligt tre gange om ugen, eller alternativt regime) for at forhindre indlæggelse eller død hos patienter med høj risiko for KOL-eksacerbationer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

RELIANCE er et amerikansk-baseret pragmatisk klinisk forsøg finansieret af Patient-Centered Outcomes Research Institute (PCORI) for at sammenligne langtidsbrug af roflumilast vs. azithromycin hos op til 3.200 patienter. Det er beregnet til at støtte hospitalets indsats for at reducere risikoen for hospitalsindlæggelse af alle årsager og reducere for tidlige dødsfald hos personer med kronisk obstruktiv lungesygdom (KOL), som har været indlagt i det foregående år på grund af en KOL-eksacerbation. COPD Patient Powered Research Network (PPRN) og tilknyttede efterforskere vil udføre forsøget på steder i USA.

Både roflumilast og azithromycin har vist sig at reducere risikoen for KOL-eksacerbationer sammenlignet med placebo. Der har dog ikke været en direkte sammenligning af de to medicin. Så de relative skader og fordele ved de to medicin er ukendte. Berettigede patienter vil blive randomiseret (1:1) til at modtage enten en recept på roflumilast eller en recept på azithromycin og vil blive fulgt i mindst 6 og op til 36 måneder. Det primære endepunkt er det kombinerede resultat af hospitalsindlæggelse eller død af alle årsager; de sekundære endepunkter inkluderer for tidlig behandlingsophør, patientrapporterede bivirkninger og fysisk, social og følelsesmæssig sundhed. Patienter vil blive indskrevet på deltagende kliniske steder, og opfølgningsdata vil blive indsamlet via en online patientportal eller via et callcenter. Baseline- og resultatdata vil også blive indsamlet fra webstedets lægejournaler og administrative/kravsdatabaser.

Pragmatisk, non-inferioritetsundersøgelse, der bruger en intention-to-treat-analyse for at evaluere, om daglig azithromycin er non-inferior i forhold til daglig roflumilast hos patienter med høj risiko for KOL-eksacerbationer. Efterforskerne vil randomisere individuelle patienter til at modtage recepter på roflumilast eller azithromycin (1:1-forhold), stratificeret efter sted og aktuel rygestatus (ja/nej).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1032

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University Of Alabama
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85734
        • University of Arizona
    • California
      • Sacramento, California, Forenede Stater, 95817
        • University of California, Davis Health
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois Chicago
      • Glenview, Illinois, Forenede Stater, 60026
        • NorthShore Hospital
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21224
        • Johns Hopkins University
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Health
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
        • University of Missouri, Kansas City
    • New York
      • Mount Kisco, New York, Forenede Stater, 10549
        • Lenox Hill/Northern Westchester Hospital (Northwell Health)
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina, School of Medicine
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, Forenede Stater, 97227
        • Kaiser Permanente
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburg Medical Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor Scott & White (BSW) Health-North
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • University of Vermont
    • Washington
      • Spokane, Washington, Forenede Stater, 99204
        • Providence Health and Services

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Patient og behandlende kliniker overvejer intensivering af behandlingen med roflumilast eller azithromycin for at reducere risikoen for KOL-eksacerbationer
  • Alder ≥ 40 år
  • Nuværende eller tidligere ryger på mindst 10 pakkeår
  • Diagnose af svær KOL og associeret kronisk bronkitis
  • Indlagt med diagnosen KOL-eksacerbation inden for de seneste 12 måneder
  • Nuværende medicin inkluderer inhaleret langtidsvirkende muskarinantagonist (LAMA), langtidsvirkende beta-agonist (LABA) /LAMA eller inhalerede kortikosteroider (ICS) /LABA
  • engelsk eller spansktalende

Ekskluderingskriterier:

  • Ude af stand til eller afslå at give informeret samtykke;
  • Afviser at oplyse cpr-nummer eller sygesikringskravsnummer (hvis relevant)
  • Anamnese med intolerance over for azithromycin eller roflumilast, som patienten eller patientens behandlende kliniker anser for at være tilstrækkelig alvorlig til at undgå begge behandlingsmuligheder;
  • Nuværende behandling med langtidsbehandling (mere end 30 dage) roflumilast eller azithromycin (tidligere behandling med 1 eller flere doser azithromycin eller roflumilast er ikke et udelukkelseskriterium, så længe patienten og klinikeren søger muligheder for intensivering af behandlingen og vil være villige til at brug azithromycin eller roflumilast i henhold til randomiseret behandlingstildeling.)
  • Kendt overfølsomhed over for azithromycin, erythromycin, ethvert makrolid- eller ketolidantibiotikum;
  • Anamnese med kolestatisk gulsot/leverdysfunktion forbundet med tidligere brug af azithromycin
  • Moderat til alvorligt nedsat leverfunktion (Child-Pugh B eller C)
  • Nuværende graviditet
  • Enhver anden kliniker-bestemt udelukkelse i henhold til klinikerens kliniske praksis

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Roflumilast arm
Deltagerne vil modtage recept på Roflumilast (250 mcg/dag x 4 uger, derefter 500 mcg/dag eller alternativt regime) x 6 til 72 måneder
Medicin: Roflumilast
Recept på Roflumilast (250 mcg/dag x 4 uger, derefter 500 mcg/dag eller alternativt regime) x 6 til 72 måneder
Andre navne:
  • Daliresp
Aktiv komparator: Azithromycin arm
Deltagerne vil modtage recept på Azithromycin (250 mg/dag eller 500 mg tre gange om ugen, eller alternativt regime) x 6 til 72 måneder
Medicin: Azithromycin
Recept på Azithromycin (250 mg/dag eller 500 mg tre gange om ugen, eller alternativt regime) x 6 til 72 måneder
Andre navne:
  • Zithromax

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to first all-cause hospitalization or all-cause death
Tidsramme: Baseline to study exit (up to 72 months)
Composite time-to-event outcome defined as time from randomization to the first occurrence of all-cause hospitalization or all-cause death.
Baseline to study exit (up to 72 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to first moderate COPD exacerbation, all-cause hospitalization, or all-cause death
Tidsramme: Baseline to study exit (up to 72 months)
Composite time-to-event outcome defined as time from randomization to the first occurrence of moderate COPD exacerbation, all-cause hospitalization, or all-cause death. Moderate COPD exacerbation is defined as treatment with antibiotics or systemic corticosteroids for a respiratory exacerbation not associated with hospitalization.
Baseline to study exit (up to 72 months)
Time to first moderate COPD exacerbation
Tidsramme: Baseline to study exit (up to 72 months)
Time from randomization to the first moderate COPD exacerbation.
Baseline to study exit (up to 72 months)
Time to first all-cause hospitalization
Tidsramme: Baseline to study exit (up to 72 months)
Time from randomization to the first all-cause hospitalization.
Baseline to study exit (up to 72 months)
Time to all-cause death
Tidsramme: Baseline to study exit (up to 72 months)
Time from randomization to all-cause death.
Baseline to study exit (up to 72 months)
Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) scale
Tidsramme: Measured at study registration, 3 months, and 6 months
Change in physical function from study registration to 6 months using the PROMIS physical function measure. Higher scores indicate better physical function. Score range 1-5 (i.e., a score of 5 is the most favorable and a score of 1 is least favorable).
Measured at study registration, 3 months, and 6 months
Change in sleep disturbance as assessed by the PROMIS scale
Tidsramme: Measured at study registration 3 months, and 6 months
Change in sleep disturbance from study registration to 6 months using the PROMIS sleep disturbance measure. Lower scores indicate more sleep disturbance. Score range 1-5 (i.e., a score of 1 is most favorable and 5 is least favorable).
Measured at study registration 3 months, and 6 months
Change in fatigue as assessed by the PROMIS scale
Tidsramme: Measured at study registration 3 months, and 6 months
Change in fatigue from study registration to 6 months using the PROMIS fatigue measure. Higher scores indicate greater fatigue. Score range 0-4 (i.e., a score of 0 is most favorable and 4 is least favorable).
Measured at study registration 3 months, and 6 months
Change in anxiety as assessed by the PROMIS scale
Tidsramme: Measured at study registration, 3 months, and 6 months
Change in anxiety from study registration to 6 months using the PROMIS anxiety measure. Higher scores indicate greater anxiety. Score range 1-5 (i.e., a score of 1 is most favorable and 5 is least favorable).
Measured at study registration, 3 months, and 6 months
Change in depression as assessed by the PROMIS scale
Tidsramme: Measured at study registration, 3 months, and 6 months
Change in depression from study registration to 6 months using the PROMIS depression measure. Higher scores indicate greater depression. Score range 1-5 (i.e., a score of 1 is most favorable and 5 is least favorable).
Measured at study registration, 3 months, and 6 months
Rate of Difficulty hearing or ringing in ears
Tidsramme: 1 week until study exit (up to 72 months)]
Event rate (per person-year) reporting difficulty hearing or ringing in ears during follow-up
1 week until study exit (up to 72 months)]
Rate of Diarrhea
Tidsramme: 1 week until study exit (up to 72 months)
Event rate (per person-year) reporting diarrhea during follow-up
1 week until study exit (up to 72 months)
Rate of Nausea
Tidsramme: 1 week until study exit (up to 72 months
Event rate (per person-year) reporting nausea during follow-up
1 week until study exit (up to 72 months
Number of participants reporting thoughts of suicide or self-harm
Tidsramme: 1 week until study exit (up to 72 months
Number of participants reporting suicidal ideation during follow-up
1 week until study exit (up to 72 months
Macrolide-resistant organisms in sputum
Tidsramme: Randomization to study exit (up to 72 months)
The number of participants with a positive sputum test for macrolide resistant organisms in the subset of participants whose electronic health record included testing while in the study
Randomization to study exit (up to 72 months)
Proportion of participants reporting treatment adherence at 1 week
Tidsramme: I week
Proportion of participants reporting use of assigned treatment at 1 week
I week
Proportion of participants reporting treatment adherence at 3 months
Tidsramme: 3 months
Proportion of participants reporting use of assigned study treatment at 3 months.
3 months
Proportion of Participants reporting Treatment adherence from 6 months to study exit (up to 72 months)
Tidsramme: 6 months to study exit (up to 72 months)
For each participant, adherence is defined as the proportion of evaluable follow-up assessments at which the participant reports use of assigned study treatment. The outcome summarizes participant-reported adherence across follow-up from 6 months to study exit (up to 72 months) among participants with at least one evaluable medication use assessment as an event rate (per person year).
6 months to study exit (up to 72 months)
Number of participants who switch to alternate study treatment
Tidsramme: 1 week, 3 months, 6 months and every 6 months up to 72 months
Number of participants with any follow-up report of prescription for the alternative study treatment after randomization.
1 week, 3 months, 6 months and every 6 months up to 72 months
Out of pocket cost for study treatment
Tidsramme: 1 week, 3 months, 6 months and every 6 months up to 72 months
Participant-reported out-of-pocket cost (measured in U.S. dollars) for assigned study treatment.
1 week, 3 months, 6 months and every 6 months up to 72 months
Change in weight (pounds)
Tidsramme: Measured at baseline, 3 months, and 6 months
Change from baseline in participant-reported weight (measured in pounds)
Measured at baseline, 3 months, and 6 months
Number of participants who discontinued assigned study treatment
Tidsramme: 1 week, 3 months, 6 months and every 6 months up to 72 months
Number of participants meeting protocol-defined treatment discontinuation, defined as the earliest follow-up assessment at which the participant reports not taking assigned study treatment during the interval since the prior assessment, with no subsequent report of treatment use. Because medication use is collected over recall intervals rather than exact stop dates, discontinuation reflects the earliest follow-up time point consistent with persistent non-use of assigned study treatment.
1 week, 3 months, 6 months and every 6 months up to 72 months

Samarbejdspartnere og efterforskere

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

Sponsor

Johns Hopkins University

Samarbejdspartnere

Patient-Centered Outcomes Research Institute
University of Illinois at Chicago

Efterforskere

  • Ledende efterforsker: Jerry Krishnan, MD, PhD, University of Illinois at Chicago
  • Ledende efterforsker: Robert Wise, MD, Johns Hopkins School of Medicine

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)

11. februar 2020

Primær færdiggørelse (Faktiske)

1. marts 2026

Studieafslutning (Faktiske)

1. marts 2026

Datoer for studieregistrering

Først indsendt

23. august 2019

Først indsendt, der opfyldte QC-kriterier

23. august 2019

Først opslået (Faktiske)

28. august 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00179281
  • contract # PCS-1504-30430 (Andet bevillings-/finansieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The Inter-University Consortium for Political and Social Research (ICPSR) at the University of Michigan will provide data archiving and dissemination services for RELIANCE. After entering into a Restricted-Use Data Contributor Agreement with ICPSR, the RELIANCE Data Coordinating Center (DCC) will prepare and transfer restricted-use files for the analyzable data set and supporting document to ICPSR. The data files will be prepared per Safe Harbor methods for compliance with the HIPAA Privacy Rule. IPD includes: demographic data, BMI, type of insurance, smoking history, COPD treatments; lung function measurements, comorbidities, use of study assigned treatment, responses to quality of life questions, adverse events, symptoms and information on hospitalizations and death.

IPD-delingstidsramme

The start date will be after 5/1/2027. Data and document transfer and curation is scheduled to be completed by 5/1/2027 after which PCORI (study funder) will determine the start date based on the publication status of the primary results manuscript or Final Research Report. There is no end date.

IPD-delingsadgangskriterier

Investigators submit requests via ICPSR web-based data access request system. Requests include investigator, research staff and institution information, proposed research purpose/description, specific files needed, signed confidentiality pledges, data security plan, IRB approval or exemption for proposed research, assurance that data use is to develop/contribute to generalizable knowledge, and justification research project can be achieved using the requested data. Requests are evaluated by an independent committee. If approved, ICSPR and Investigator enter into a Restricted Data Use Agreement for Restricted Data in the Virtual Data Enclave (VDE), which describes investigator, research staff and institution obligations including data use only for described project, compliance with data security plan, access limited to persons identified in agreement, and no attempts to identify private persons are permitted. Data is made available via the VDE, a secure remote-access workspace.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 Kronisk bronkitis

Kliniske forsøg med Roflumilast

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Egypt

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner