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

1. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

240

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: 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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Rate of Moderate and Severe COPD Exacerbations
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Severe COPD exacerbation rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Tel-Aviv Sourasky Medical Center

Spolupracovníci

AstraZeneca

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

1. června 2026

První předloženo, které splnilo kritéria kontroly kvality

1. června 2026

První zveřejněno (Aktuální)

5. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 0690-25-TLV

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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