COPD Flare-Up Clinic After Severe Exacerbations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorTel-Aviv Sourasky Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Follow-up in a flare-up clinic
Other interventionParticipants 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of Moderate and Severe COPD Exacerbations
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.
Time frame
From baseline to 12 monthsSecondary outcomes
1
Severe COPD exacerbation rate
The rate of COPD exacerbations leading to hospital arrival between the intervention and control
Time frame
During study follow-up (12 months from inclusion)2
Percentage with any COPD exacerbation
The percentage of patients in each study group with 1 or more COPD exacerbations (moderate or severe)
Time frame
During study follow-up (12 months from inclusion).3
Time to First COPD Exacerbation
Time to first COPD exacerbation between the intervention and control
Time frame
During study follow-up (12 months from inclusion).4
Time to First Hospital Arrival
Time to first hospital arrival due to asthma exacerbation and from any cause between the intervention and control
Time frame
During study follow-up (12 months from inclusion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tel-Aviv Sourasky Medical Center
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov