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NCT Number: NCT07543601

Enhanced COPD Management in Suspected Lung Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lung Cancer Investigation Unit, Lillebaelt Hospital Vejle

Vejle, 7100, Denmark

Location status: Recruiting

Location contact

Anders Løkke, MD, PhD, Professor, Consultant

SUB_INVESTIGATOR

Ditte Krag-Hansen, MD, PhD student

CONTACT

[email protected]

+45 7940 5720

Ditte Krag-Hansen, MD, PhD student

PRINCIPAL_INVESTIGATOR

Ingeborg Farver-Vestergaard, PsyD, PhD, Associate Professor

SUB_INVESTIGATOR

Morten Hornemann Borg, MD, PhD, Chief consultant

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored COPD consultations

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight

    Time frame: Baseline and after 6 months

    kg Reviews the change

  2. Height

    Time frame: Basline

    cm

  3. BMI

    Time frame: Baseline and after 6 months

    kg/m^2 Reviews the change

  4. 1 min sit-to-stand-test

    Time frame: Baseline and after 6 months

    The higher the number the better

  5. 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

  6. 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

  7. 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.

  8. Number of exacerbations

    Time frame: Baseline, after 3 months and after 6 months

    Self-reported through interview and medical records

  9. Mortality

    Time frame: After 3 months and after 6 months

    Lost to follow up because of death

  10. Hospitalisations

    Time frame: Baseline, after 3 months and after 6 months

    Prevalence Self-reported through interview and medical records

  11. Incidence of Treatment-Emergent Adverse Events

    Time frame: After 3 months and after 6 months

    Cancer treatment Self reported through interview and medical records

  12. Postoperative recovery

    Time frame: After 3 months and after 6 months

    Self-reported through interview and medical records

  13. Overall survival

    Time frame: After 3 months and after 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ditte Krag-Hansen, MD, PhD student

CONTACT

[email protected]

+45 7940 5720

Morten Hornemann Borg, MD, PhD, Chief consultant

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Ditte Krag-Hansen

Other

Collaborators

  • AstraZeneca
  • Sygehus Lillebaelt

Registry information

Official study title

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

Acronym: ECHELON

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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