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NCT Number: NCT07629869

COPD Flare-Up Clinic After Severe 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.

The researches 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.

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Key information

Conditions

COPD COPD Exacerbation (AECOPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906

Tel Aviv, Israel

Location contact

Ophir Freund, Medical Doctor (Pulmonologist)

CONTACT

[email protected]

+972545305648

About this study

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, the researchers 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, the study will enroll 120 patients per group, for a total of 240 participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Follow-up in a flare-up clinic

Other

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.

Primary outcomes

  1. Rate of Moderate and Severe COPD Exacerbations

    Time frame: 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.

Secondary outcomes

  1. Severe COPD exacerbation rate

    Time frame: During study follow-up (12 months from inclusion)

    The rate of COPD exacerbations leading to hospital arrival between the intervention and control

  2. Percentage with any COPD exacerbation

    Time frame: 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)

  3. Time to First COPD Exacerbation

    Time frame: During study follow-up (12 months from inclusion).

    Time to first COPD exacerbation between the intervention and control

  4. Time to First Hospital Arrival

    Time frame: 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

  5. Number of Moderate and Severe COPD Exacerbations (per-protocol)

    Time frame: 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.

  6. Change in Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 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.

  7. Oscillometric changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz

    Time frame: 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.

  8. Oscillometric changes in area of reactance

    Time frame: 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.

  9. Respiratory Symptoms Burden Assessed by CAT

    Time frame: 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.

  10. Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale

    Time frame: Assessed by a physician at baseline, and subsequent 12 months following study initiation.

    Will be evaluated using the Modified Medical Research Council Dyspnea Scale (mMRC) Dyspnea Scale: a patient-reported tool used to assess the degree of baseline breathlessness related to physical activity. Scores are between 0 and 4, with higher score indicating higher severity of breathlessness.

  11. Differences In New Diagnoses of Cardiovascular Comorbidities (12 months)

    Time frame: 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.

  12. Composite of Major Cardiovascular Events

    Time frame: 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.

  13. Composite cardio-pulmonary outcome

    Time frame: 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.

  14. Change in SGRQ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: FLARE-COPD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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