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COPD Flare-Up Clinic After Severe Exacerbations (FLARE-COPD)

1. juni 2026 opdateret af: Tel-Aviv Sourasky Medical Center

The Role of COPD Flare-up Clinic Service After Severe Exacerbations to Reduce Recurrent Exacerbations

This prospective randomized controlled trial evaluates whether a specialized "COPD flare-up clinic service" improves outcomes in patients following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Patients presenting to the emergency department with AECOPD and discharged or hospitalized will be randomized 1:1 to either structured follow-up in a dedicated flare-up clinic or standard follow-up by scheduled telephone interviews.

We hypothesize that structured follow-up in a specialized clinic will reduce recurrent exacerbations, optimize long-term COPD management, and improve patients' quality of life compared to standard care.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary outcome is to determine whether the flare-up clinic intervention reduces the annualized rate of moderate and severe COPD exacerbations over 12 months. Secondary outcomes include effect of the intervention on the long-term management of COPD and related comorbidities, patients' quality of life, and mortality.

  • Randomization // A total of 240 participants with established COPD presenting to the emergency department with an acute exacerbation (AECOPD) will be randomized in a 1:1 ratio to either the intervention or control group. To ensure balance across key clinical pathways, randomization will be stratified by the disposition of the index visit: Emergency Department (ED) discharge versus acute hospitalization. Within each stratum, treatment assignments will be determined using a computer-generated random allocation sequence utilizing variable block sizes of two or four. To prevent selection bias and maintain strict allocation concealment, the randomization schedule will be generated and housed within a secure, centralized electronic system managed exclusively by an independent study coordinator. The clinical research team, including investigators responsible for patient enrollment and clinical care, will remain entirely removed from sequence generation and block determination. Allocation will be revealed sequentially on a patient-by-patient basis only after a participant's eligibility is confirmed and the index visit disposition is finalized.
  • Sample size calculation // Based on prior studies, we anticipate that the intervention will reduce the rate of moderate or severe COPD exacerbations by approximately 33% over 12 months, with a clinically meaningful effect considered at 20-25%. Assuming that 60% of patients in the control group will experience at least one exacerbation during this period, a sample size of 95 patients per group is required to achieve 80% power with a two-sided alpha of 0.05. To account for a potential 15-20% loss to follow-up, we plan to enroll 120 patients per group, for a total of 240 participants.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906
        • Kontakt:
          • Ophir Freund, Medical Doctor (Pulmonologist)
          • Telefonnummer: +972545305648
          • E-mail: ophir068@gmail.com

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Prior COPD diagnosis based on clinical and spirometry accepted criteria.
  • Acute exacerbation of COPD as the main reason for ED arrival.
  • Ability to perform in-person and telephone follow-up.
  • Agree to participate, with a signed informed consent.

Exclusion Criteria:

  • Symptomatic heart failure as the main reason for emergency department visit in the last 6 months.
  • Uncontrolled comorbidity.
  • Vulnerable Populations: To ensure ethical compliance and participant safety, the study will exclude vulnerable populations. This includes pregnant women, and any person lacking the mental or legal capacity to provide independent informed consent.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
The intervention will include 3 follow-up visits in the flare up clinic - the first visit (following randomization) will occur one month after hospital discharge (from ED or admission, baseline), the second at 3 months, and the third visit will be at 12 months from baseline. At 6 and 9 months after inclusion there will be an additional phone-call with structured interview similar to that of the control group. Visits include clinical evaluation, symptom assessment, spirometry, oscillometry, inhaler technique review, cardiovascular risk assessment, and treatment optimization according to GOLD recommendations.
Andet: Follow-up in a flare-up clinic
Participants in the intervention arm will attend a specialized "COPD flare-up clinic" for structured follow-up after hospitalization or ED visit due to acute COPD exacerbation. The program includes three in-person clinic visits at 1, 4, and 10 months after the first visit, and two additional structured telephone follow-up at 10 and 18 months. To assess cardiovascular outcomes, a follow-up phone call will be conducted 24 months after Visit 1.
Ingen indgriben: Control
The control group will undergo baseline and 12 months in-person assessments including all questionnaires and physiological tests but without any medical interventions. Structured telephone follow-up at 3, 6, and 9 months will be performed by research coordinators to assess for the study outcomes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Moderate and Severe COPD Exacerbations
Tidsramme: From baseline to 12 months
Annualized rate of moderate or severe exacerbations of COPD which occurred during the 12-month trial period. Moderate exacerbations require systemic steroids and/or antibiotics, while severe exacerbations lead to hospitalization, ED visit, or death. The rate will be compared between the intervention and control groups. This will be assessed as intention to treat.
From baseline to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severe COPD exacerbation rate
Tidsramme: During study follow-up (12 months from inclusion)
The rate of COPD exacerbations leading to hospital arrival between the intervention and control
During study follow-up (12 months from inclusion)
Percentage with any COPD exacerbation
Tidsramme: During study follow-up (12 months from inclusion).
The percentage of patients in each study group with 1 or more COPD exacerbations (moderate or severe)
During study follow-up (12 months from inclusion).
Time to First COPD Exacerbation
Tidsramme: During study follow-up (12 months from inclusion).
Time to first COPD exacerbation between the intervention and control
During study follow-up (12 months from inclusion).
Time to First Hospital Arrival
Tidsramme: During study follow-up (12 months from inclusion)
Time to first hospital arrival due to asthma exacerbation and from any cause between the intervention and control
During study follow-up (12 months from inclusion)
Number of Moderate and Severe COPD Exacerbations (per-protocol)
Tidsramme: 12 months from the first follow-up visit
The annualized rate of moderate or severe COPD exacerbations will be compared between the intervention and control groups using an per-protocol approach. Moderate exacerbations are defined as those requiring treatment with systemic glucocorticoids, antibiotics, or both. Severe exacerbations are defined as those leading to an emergency department visit, hospitalization, or death. Patients excluded from each group will be those lost to follow-up, defined as failing to complete 2 follow-up visits or calls.
12 months from the first follow-up visit
Change in Forced Expiratory Volume in 1 second (FEV1)
Tidsramme: Spirometry will be performed according to ATS/ERS guidelines, under supervision of trained personnel at baseline and after 12 months.
FEV1 will be measured using standard spirometry at baseline and at the 12 month follow-up visit. The primary analysis will evaluate the mean change in FEV1 (in liters) from baseline to 12 months between the intervention and control groups using an per-protocol approach.
Spirometry will be performed according to ATS/ERS guidelines, under supervision of trained personnel at baseline and after 12 months.
Oscillometric changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz
Tidsramme: During study follow-up (12 months from inclusion)
Oscillometric change in respiratory resistance at 5 Hz (R5, measured in kPa/L/s) and 20 Hz (R20, measured in kPa/L/s), the difference between R5 and R20 (R5-20, measured in kPa/L/s), and R5-20/R5 - all changes from baseline to 12 months compared between the study groups.
During study follow-up (12 months from inclusion)
Oscillometric changes in area of reactance
Tidsramme: During study follow-up (12 months from inclusion)
Oscillometric changes in area of reactance (AX), measured in KPa/L/s. Changes will be measured from baseline to 12 months and compared between the groups.
During study follow-up (12 months from inclusion)
Respiratory Symptoms Burden Assessed by CAT
Tidsramme: Assessed from enrollment to 12 months following study initiation.
Will be evaluated using the COPD Assessment Test (CAT), an eight items patient-administered questionnaire assessing respiratory symptoms, confidence, sleep, and energy levels. The total score ranges from 0 to 40, with higher scores indicating greater symptom burden. We will make 2 analysis - first as intention to treat approach, and then per-protocol.
Assessed from enrollment to 12 months following study initiation.
Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale
Tidsramme: Assessed by a physician at baseline, and subsequent 12 months following study initiation.
Will be evaluated using the tool mMRC Dyspnea Scale: a patient-reported tool used to assess the degree of baseline breathlessness related to physical activity.
Assessed by a physician at baseline, and subsequent 12 months following study initiation.
Differences In New Diagnoses of Cardiovascular Comorbidities (12 months)
Tidsramme: From baseline and to 12 months.
Comparison of new cardiovascular diagnoses between the study groups (rates), including hypertension, diabetes, hyperlipidemia, coronary artery disease and heart failure between the study groups.
From baseline and to 12 months.
Composite of Major Cardiovascular Events
Tidsramme: During study follow-up (12 months from inclusion).
Number of patients experiencing at least one major cardiovascular event, including acute coronary syndrome, stroke, heart failure exacerbation, or death.
During study follow-up (12 months from inclusion).
Composite cardio-pulmonary outcome
Tidsramme: From inclusion to 12 months
Number of patients experiencing at least one major cardiovascular event, including acute coronary syndrome, stroke, or heart failure exacerbation or COPD exacerbation or death.
From inclusion to 12 months
Change in SGRQ
Tidsramme: From baseline to 12 months
The St. George's Respiratory Questionnaire (SGRQ) is a standardized questionnaire used to measure health-related quality of life in patients with COPD. Scores range from 0 to 100, with higher socres indicating worse outcome. This outcome will assess changes from baseline to 12 months between the two groups.
From baseline to 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Tel-Aviv Sourasky Medical Center

Samarbejdspartnere

AstraZeneca

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

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 (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0690-25-TLV

Plan for individuelle deltagerdata (IPD)

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Ingen

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