COPD Flare-Up Clinic After Severe Exacerbations

NCT07629869 | Not Yet Recruiting

• 1 other identifier: 0690-25-TLV
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

COPD; COPD Exacerbation (AECOPD)

Keywords

COPD management; COPD flare-up; COPD exacerbation

Outcome Measures

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.

  From baseline to 12 months

Secondary Outcomes (14)

• Severe COPD exacerbation rate

  During study follow-up (12 months from inclusion)

• Percentage with any COPD exacerbation

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

• Time to First COPD Exacerbation

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

• Time to First Hospital Arrival

  During study follow-up (12 months from inclusion)

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

  12 months from the first follow-up visit

Study Arms (2)

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.

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906

Tel Aviv, Israel

Location

Related Publications (10)

• 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.

  PMID: 16785478 BACKGROUND

• Parums 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.

  PMID: 37777859 BACKGROUND

• Agusti 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.

  PMID: 36858443 BACKGROUND

• Nici 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.

  PMID: 32283960 BACKGROUND

• Bar-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.

  PMID: 37692773 BACKGROUND

• Kitchlu 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.

  PMID: 25886627 BACKGROUND

• Choi 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.

  PMID: 15111474 BACKGROUND

• Chapman 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.

  PMID: 12647940 BACKGROUND

• Donaldson 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.

  PMID: 12324669 BACKGROUND

• Anzueto A. Impact of exacerbations on COPD. Eur Respir Rev. 2010 Jun;19(116):113-8. doi: 10.1183/09059180.00002610.

  PMID: 20956179 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)