Enhanced COPD Management in Suspected Lung Cancer Patients (ECHELON)

April 15, 2026 updated by: Ditte Krag-Hansen

Enhanced COPD Management in Suspected Lung Cancer Patients - Improving Outcomes Through Timely Intervention

Identifying and treating COPD in patients undergoing lung cancer evaluation is crucial. Early intervention could lead to better management of both diseases, improving health status, reducing healthcare costs, and potentially increasing survival rates.

This study aims to assess the impact of early diagnosis and optimal treatment of COPD on clinical outcomes in patients under evaluation for lung cancer. The study will combine information through an open-label RCT at the Lung Cancer Investigation Unit at Lillebaelt Hospital Vejle.

The findings could inform clinical practice by emphasizing the importance of integrated care approaches for patients with coexisting COPD and lung cancer, ultimately leading to better health outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) and lung cancer frequently coexist due to shared risk factors, most notably smoking, which is the leading cause of both conditions. COPD, characterized by persistent airflow limitation and chronic inflammation of the airways, is a major contributor to morbidity and mortality worldwide. Similarly, lung cancer is one of the most common and deadliest cancers, with a significant overlap in the patient populations affected by COPD. Studies suggest that individuals with COPD are at an increased risk of developing lung cancer, with rates estimated to be four to six times higher than in the general population. This overlap is not merely coincidental but is thought to be influenced by chronic inflammation, oxidative stress, and impaired immune responses in the lungs of patients with COPD, which can promote carcinogenesis.

Despite the frequent coexistence of COPD and lung cancer, patients are usually not investigated for COPD as usual care, therefore, COPD often remains underdiagnosed or is diagnosed late, particularly in patients being evaluated for lung cancer. Delayed diagnosis and untreated COPD can negatively affect a patient's overall prognosis, complicating the management of lung cancer. At the same time, some patients with COPD are incorrectly diagnosed and suboptimal treated resulting in progressive deterioration of health status. Deterioration of health status including lung function is contributed by comorbidities in patients with COPD especially cardiovascular diseases.

Overall, patients with COPD tend to have poorer tolerance to lung cancer treatments, including surgery, chemotherapy, and radiotherapy, due to compromised lung function. In contrast, early detection and optimal management of COPD, including pharmacotherapy, smoking cessation, and pulmonary rehabilitation, may improve lung function, enhance treatment tolerance, and reduce complications during cancer therapy.

Given the high prevalence of both COPD and lung cancer in individuals with a history of smoking, identifying and treating COPD in patients undergoing lung cancer evaluation is crucial. Early intervention could lead to better management of both diseases, improving health status, reducing healthcare costs, and potentially increasing survival rates. This study aims to assess the impact of early diagnosis and optimal treatment of COPD on clinical outcomes in patients under evaluation for lung cancer. Specifically, it will explore how timely COPD management affects cancer treatment tolerability, postoperative recovery, hospitalization rates, and overall survival in this high-risk population. The findings could inform clinical practice by emphasizing the importance of integrated care approaches for patients with coexisting COPD and lung cancer, ultimately leading to better health outcomes.

Aim and objectives To assess the impact of early COPD diagnosis and optimal treatment on health status outcomes in patients undergoing lung cancer work-up and to evaluate the effect of early COPD diagnosis and optimal treatment on COPD-related health status in patients undergoing lung cancer work-up.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Vejle, Denmark, 7100
        • Recruiting
        • Lung Cancer Investigation Unit, Lillebaelt Hospital Vejle
        • Contact:
        • Sub-Investigator:
          • Morten Hornemann Borg, MD, PhD, Chief consultant
        • Sub-Investigator:
          • Anders Løkke, MD, PhD, Professor, Consultant
        • Sub-Investigator:
          • Ingeborg Farver-Vestergaard, PsyD, PhD, Associate Professor
        • Principal Investigator:
          • Ditte Krag-Hansen, MD, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing diagnostic evaluation for suspected lung cancer
  • Spirometry showing obstructive airflow limitation (FEV₁/FVC < 75 % or FEV₁ < 80 %, and no reversibility) at the first outpatient visit at the lung cancer evaluation

Exclusion Criteria:

  • Presence of significant comorbidities that may interfere with diagnostic procedures or spirometry
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Lung cancer investigation only
Experimental: Tailored COPD consultation

Tailored COPD consultations will include assessment and treatment according to GOLD guidelines, including:

Pharmacological management Smoking cessation support Referral to pulmonary rehabilitation as appropriate Referral for nutritional assessment and optimization when appropriate Referral to cardiovascular evaluation when appropriate Referral to sleep apnea evaluation when appropriate
Other: Tailored COPD consultations

These consultations will include assessment and treatment according to GOLD guidelines, including:

Pharmacological management Smoking cessation support Referral to pulmonary rehabilitation as appropriate Referral for nutritional assessment and optimization when appropriate Referral to cardiovascular evaluation when appropriate Referral to sleep apnea evaluation when appropriate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAT score
Time Frame: Baseline, after 3 months and after 6 months
CAT consists of a questionnaire with eight items with the possibility of scoring 0-40 on respiratory symptoms. Participants will be tested at baseline, and after a follow-up period of 3 and 6 months after enrollment of the study.
Baseline, after 3 months and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline and after 6 months
kg Reviews the change
Baseline and after 6 months
Height
Time Frame: Basline
cm
Basline
BMI
Time Frame: Baseline and after 6 months
kg/m^2 Reviews the change
Baseline and after 6 months
1 min sit-to-stand-test
Time Frame: Baseline and after 6 months
The higher the number the better
Baseline and after 6 months
The ProKOL questionnaire
Time Frame: Baseline, after 3 months and after 6 months

To clarify treatment and rehabilitation needs through patient reported outcomes related to COPD specific questions.

Reviewed on a scale from zero to five with lower numbers being better outcomes
Baseline, after 3 months and after 6 months
The HADS questionnaire
Time Frame: Baseline, after 3 months and after 6 months

Consists of multiple questions regarding the risk of developing anxiety or depression.

0-7 points are normal 8-10 points are borderline abnormal 11-21 points are abnormal
Baseline, after 3 months and after 6 months
Smoking cessation
Time Frame: Baseline, after 3 months and after 6 months
Self-reported through interview. Attempts at cessation, succeeded cessation or more motivated to cessation are perceived as an improvement.
Baseline, after 3 months and after 6 months
Number of exacerbations
Time Frame: Baseline, after 3 months and after 6 months
Self-reported through interview and medical records
Baseline, after 3 months and after 6 months
Mortality
Time Frame: After 3 months and after 6 months
Lost to follow up because of death
After 3 months and after 6 months
Hospitalisations
Time Frame: Baseline, after 3 months and after 6 months
Prevalence Self-reported through interview and medical records
Baseline, after 3 months and after 6 months
Incidence of Treatment-Emergent Adverse Events
Time Frame: After 3 months and after 6 months
Cancer treatment Self reported through interview and medical records
After 3 months and after 6 months
Postoperative recovery
Time Frame: After 3 months and after 6 months
Self-reported through interview and medical records
After 3 months and after 6 months
Overall survival
Time Frame: After 3 months and after 6 months
After 3 months and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ditte Krag-Hansen

Collaborators

AstraZeneca
Sygehus Lillebaelt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Journal nr.: 25/71
  • Project-ID S-20250091 (Other Identifier: The Health Research Ethics Committee, Region of Southern Denmark)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The collection and storage of personal data will comply with the Data Protection Act and the GDPR. The results of the project will be treated confidentially. The results will be stored on a secure server controlled by the Region of Southern Denmark. The results will only be disclosed in pseudonymised (de-identified) form, where neither your name, date of birth, address, nor the like will be disclosed. The results from the project will be published in an anonymous form. The individual participant data collected throughout the course of the study and the analyzable data set will not be openly disclosed due to data protection.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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