COPD, COPD Exacerbation (AECOPD)
Conditions
Keywords
COPD management, COPD flare-up, COPD exacerbation
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Tel-Aviv Sourasky Medical Center
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcomes will be assessed by a unified form that will be filled by the patients or by a research coordinator that will be blinded to group allocation. All forms from a specific visit / follow-up point will be placed in the same folder without identifying information on group allocation. After 110 patients will be recruited only the amount of patients allocated to each group and side effects will be assessed by an investigator not part of the research group to assess safety and for reporting purposes. All data will be entered into a database at the end of the study by personnel blinded to group allocation. Statistical analysis will also be performed by a statistician blinded to group allocation.
Intervention model description
The intervention group will attend a structured flare-up clinic program with pulmonologist visits at baseline (1-month from exacerbation), 3, and 12 months, plus a telephone follow-up at 6 and 9 months. Visits include clinical evaluation, symptom assessment, spirometry, oscillometry, inhaler technique review, cardiovascular risk assessment, and treatment optimization according to GOLD recommendations. The control group will undergo in-person assessment without medical intervention at baseline and 12 months. Additional structured telephone follow-up will occur at 3, 6, and 9 months without physician intervention.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Moderate and Severe COPD Exacerbations | 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
| Measure | Time frame | Description |
|---|---|---|
| Severe COPD exacerbation rate | During study follow-up (12 months from inclusion) | The rate of COPD exacerbations leading to hospital arrival between the intervention and control |
| Percentage with any COPD exacerbation | 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) |
| Time to First COPD Exacerbation | During study follow-up (12 months from inclusion). | Time to first COPD exacerbation between the intervention and control |
| Time to First Hospital Arrival | 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 |
| Number of Moderate and Severe COPD Exacerbations (per-protocol) | 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. |
| Change in Forced Expiratory Volume in 1 second (FEV1) | 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. |
| Oscillometric changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz | 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. |
| Oscillometric changes in area of reactance | 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. |
| Respiratory Symptoms Burden Assessed by CAT | 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. |
| Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale | 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. |
| Differences In New Diagnoses of Cardiovascular Comorbidities (12 months) | 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. |
| Composite of Major Cardiovascular Events | 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. |
| Composite cardio-pulmonary outcome | 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. |
| Change in SGRQ | 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. |
Countries
Israel
Outcome results
None listed