COPDFLARE-COPDNCT07629869
COPD Flare-Up Clinic After Severe Exacerbations
A study testing Follow-up in a flare-up clinic in people with COPD and COPD Exacerbation (AECOPD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, COPD Exacerbation (AECOPD)
- What is being tested?
- Follow-up in a flare-up clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906
Tel Aviv
Ophir Freund, Medical Doctor (Pulmonologist), +972545305648, ophir068@gmail.com
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- COPD, COPD Exacerbation (AECOPD)
- Being tested
- Follow-up in a flare-up clinic
- Keywords
- COPD management, COPD flare-up, COPD exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up in a flare-up clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Follow-up in a flare-up clinic |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 months
Secondary outcomes (14)
Severe COPD exacerbation rate
The rate of COPD exacerbations leading to hospital arrival between the intervention and control
Measured: During study follow-up (12 months from inclusion)
Percentage with any COPD exacerbation
The percentage of patients in each study group with 1 or more COPD exacerbations (moderate or severe)
Measured: During study follow-up (12 months from inclusion).
Time to First COPD Exacerbation
Time to first COPD exacerbation between the intervention and control
Measured: During study follow-up (12 months from inclusion).
Time to First Hospital Arrival
Time to first hospital arrival due to asthma exacerbation and from any cause between the intervention and control
Measured: During study follow-up (12 months from inclusion)
Number of Moderate and Severe COPD Exacerbations (per-protocol)
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.
Measured: 12 months from the first follow-up visit
Change in Forced Expiratory Volume in 1 second (FEV1)
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.
Measured: 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
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.
Measured: During study follow-up (12 months from inclusion)
Oscillometric changes in area of reactance
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.
Measured: During study follow-up (12 months from inclusion)
Respiratory Symptoms Burden Assessed by CAT
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.
Measured: Assessed from enrollment to 12 months following study initiation.
Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale
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.
Measured: Assessed by a physician at baseline, and subsequent 12 months following study initiation.
Differences In New Diagnoses of Cardiovascular Comorbidities (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.
Measured: From baseline and to 12 months.
Composite of Major Cardiovascular Events
Number of patients experiencing at least one major cardiovascular event, including acute coronary syndrome, stroke, heart failure exacerbation, or death.
Measured: During study follow-up (12 months from inclusion).
Composite cardio-pulmonary outcome
Number of patients experiencing at least one major cardiovascular event, including acute coronary syndrome, stroke, or heart failure exacerbation or COPD exacerbation or death.
Measured: From inclusion to 12 months
Change in SGRQ
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.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629869
- Sponsor's protocol ID
- 0690-25-TLV
- Acronym
- FLARE-COPD
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lindenauer PK, Pekow P, Gao S, Crawford AS, Gutierrez B, Benjamin EM. Quality of care for patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 2006 Jun 20;144(12):894-903. doi: 10.7326/0003-4819-144-12-200606200-00006.
PubMed 16785478Parums DV. Editorial: Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 Guidelines for COPD, Including COVID-19, Climate Change, and Air Pollution. Med Sci Monit. 2023 Oct 1;29:e942672. doi: 10.12659/MSM.942672.
PubMed 37777859Agusti A, Celli BR, Criner GJ, Halpin D, Anzueto A, Barnes P, Bourbeau J, Han MK, Martinez FJ, Montes de Oca M, Mortimer K, Papi A, Pavord I, Roche N, Salvi S, Sin DD, Singh D, Stockley R, Lopez Varela MV, Wedzicha JA, Vogelmeier CF. Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary. Eur Respir J. 2023 Apr 1;61(4):2300239. doi: 10.1183/13993003.00239-2023. Print 2023 Apr.
PubMed 36858443Nici L, Mammen MJ, Charbek E, Alexander PE, Au DH, Boyd CM, Criner GJ, Donaldson GC, Dreher M, Fan VS, Gershon AS, Han MK, Krishnan JA, Martinez FJ, Meek PM, Morgan M, Polkey MI, Puhan MA, Sadatsafavi M, Sin DD, Washko GR, Wedzicha JA, Aaron SD. Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 May 1;201(9):e56-e69. doi: 10.1164/rccm.202003-0625ST.
PubMed 32283960Bar-Shai A, Freund O, Ovdat T, Segel MJ, Klempfner R, Elis A. Management of acute COPD exacerbations in the internal medicine departments in Israel-a national survey. Front Med (Lausanne). 2023 Aug 24;10:1174148. doi: 10.3389/fmed.2023.1174148. eCollection 2023.
PubMed 37692773Kitchlu A, Abdelshaheed T, Tullis E, Gupta S. Gaps in the inpatient management of chronic obstructive pulmonary disease exacerbation and impact of an evidence-based order set. Can Respir J. 2015 May-Jun;22(3):157-62. doi: 10.1155/2015/587026. Epub 2015 Apr 17.
PubMed 25886627Choi PP, Day A, Etchells E. Gaps in the care of patients admitted to hospital with an exacerbation of chronic obstructive pulmonary disease. CMAJ. 2004 Apr 27;170(9):1409-13. doi: 10.1503/cmaj.1030713.
PubMed 15111474Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7.
PubMed 12647940Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.
PubMed 12324669Anzueto A. Impact of exacerbations on COPD. Eur Respir Rev. 2010 Jun;19(116):113-8. doi: 10.1183/09059180.00002610.
PubMed 20956179
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of COPD Flare-up Clinic Service After Severe Exacerbations to Reduce Recurrent Exacerbations
- ClinicalTrials.gov ID
- NCT07629869
- Acronym / sponsor ID
- FLARE-COPD / 0690-25-TLV
- Conditions
- COPD, COPD Exacerbation (AECOPD)
- Keywords
- COPD management, COPD flare-up, COPD exacerbation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- AstraZeneca
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Follow-up in a flare-up clinicThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up in a flare-up clinicParticipants 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. | Other | Intervention |
Primary outcome
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.
14 secondary outcomes
Severe COPD exacerbation rate
Time frame: During study follow-up (12 months from inclusion)
Percentage with any COPD exacerbation
Time frame: During study follow-up (12 months from inclusion).
Time to First COPD Exacerbation
Time frame: During study follow-up (12 months from inclusion).
Time to First Hospital Arrival
Time frame: During study follow-up (12 months from inclusion)
Number of Moderate and Severe COPD Exacerbations (per-protocol)
Time frame: 12 months from the first follow-up visit
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.
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 changes in area of reactance
Time frame: During study follow-up (12 months from inclusion)
Respiratory Symptoms Burden Assessed by CAT
Time frame: Assessed from enrollment to 12 months following study initiation.
Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale
Time frame: Assessed by a physician at baseline, and subsequent 12 months following study initiation.
Differences In New Diagnoses of Cardiovascular Comorbidities (12 months)
Time frame: From baseline and to 12 months.
Composite of Major Cardiovascular Events
Time frame: During study follow-up (12 months from inclusion).
Composite cardio-pulmonary outcome
Time frame: From inclusion to 12 months
Change in SGRQ
Time frame: From baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 16785478Lindenauer PK, Pekow P, Gao S, Crawford AS, Gutierrez B, Benjamin EM. Quality of care for patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 2006 Jun 20;144(12):894-903. doi: 10.7326/0003-4819-144-12-200606200-00006.
- Background: PubMed 37777859Parums DV. Editorial: Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 Guidelines for COPD, Including COVID-19, Climate Change, and Air Pollution. Med Sci Monit. 2023 Oct 1;29:e942672. doi: 10.12659/MSM.942672.
- Background: PubMed 36858443Agusti A, Celli BR, Criner GJ, Halpin D, Anzueto A, Barnes P, Bourbeau J, Han MK, Martinez FJ, Montes de Oca M, Mortimer K, Papi A, Pavord I, Roche N, Salvi S, Sin DD, Singh D, Stockley R, Lopez Varela MV, Wedzicha JA, Vogelmeier CF. Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary. Eur Respir J. 2023 Apr 1;61(4):2300239. doi: 10.1183/13993003.00239-2023. Print 2023 Apr.
- Background: PubMed 32283960Nici L, Mammen MJ, Charbek E, Alexander PE, Au DH, Boyd CM, Criner GJ, Donaldson GC, Dreher M, Fan VS, Gershon AS, Han MK, Krishnan JA, Martinez FJ, Meek PM, Morgan M, Polkey MI, Puhan MA, Sadatsafavi M, Sin DD, Washko GR, Wedzicha JA, Aaron SD. Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 May 1;201(9):e56-e69. doi: 10.1164/rccm.202003-0625ST.
- Background: PubMed 37692773Bar-Shai A, Freund O, Ovdat T, Segel MJ, Klempfner R, Elis A. Management of acute COPD exacerbations in the internal medicine departments in Israel-a national survey. Front Med (Lausanne). 2023 Aug 24;10:1174148. doi: 10.3389/fmed.2023.1174148. eCollection 2023.
- Background: PubMed 25886627Kitchlu A, Abdelshaheed T, Tullis E, Gupta S. Gaps in the inpatient management of chronic obstructive pulmonary disease exacerbation and impact of an evidence-based order set. Can Respir J. 2015 May-Jun;22(3):157-62. doi: 10.1155/2015/587026. Epub 2015 Apr 17.
- Background: PubMed 15111474Choi PP, Day A, Etchells E. Gaps in the care of patients admitted to hospital with an exacerbation of chronic obstructive pulmonary disease. CMAJ. 2004 Apr 27;170(9):1409-13. doi: 10.1503/cmaj.1030713.
- Background: PubMed 12647940Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7.
- Background: PubMed 12324669Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.
- Background: PubMed 20956179Anzueto A. Impact of exacerbations on COPD. Eur Respir Rev. 2010 Jun;19(116):113-8. doi: 10.1183/09059180.00002610.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up in a flare-up clinic in people with COPD and COPD Exacerbation (AECOPD), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Moderate and Severe COPD Exacerbations (time frame: From baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07629869, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.