Skip to content

Enhanced COPD Management in Suspected Lung Cancer Patients

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07543601
Acronym
ECHELON
Enrollment
280
Registered
2026-04-22
Start date
2026-03-06
Completion date
2027-06-30
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airflow Obstruction, Chronic, COPD, COPD - Chronic Obstructive Pulmonary Disease, COPD (Chronic Obstructive Pulmonary Disease), Lung Cancer (Diagnosis), Lung Carcinoma, Lung Neoplasm Malignant, Pulmonary Cancer, Pulmonary Cancers, Pulmonary Carcinoma, Pulmonary Neoplasm, Pulmonary Neoplasms

Keywords

Invesigation, Evaluation, Diagnostic Work-up, Diagnostic Pathway

Brief summary

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.

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.

Interventions

OTHERTailored 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

Sponsors

Ditte Krag-Hansen
Lead SponsorOTHER
AstraZeneca
CollaboratorINDUSTRY
Sygehus Lillebaelt
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

The study is a randomized, controlled, open label trial. The participants who meet the criteria for COPD will be randomized to receive either tailored COPD consultations alongside their lung cancer investigation or usual care (lung cancer investigation only) with an equal allocation ratio 1:1 using a computer-generated table of random numbers in REDcap.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CAT scoreBaseline, after 3 months and after 6 monthsCAT 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

MeasureTime frameDescription
WeightBaseline and after 6 monthskg Reviews the change
HeightBaslinecm
BMIBaseline and after 6 monthskg/m\^2 Reviews the change
1 min sit-to-stand-testBaseline and after 6 monthsThe higher the number the better
The ProKOL questionnaireBaseline, after 3 months and after 6 monthsTo 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
The HADS questionnaireBaseline, after 3 months and after 6 monthsConsists 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
Smoking cessationBaseline, after 3 months and after 6 monthsSelf-reported through interview. Attempts at cessation, succeeded cessation or more motivated to cessation are perceived as an improvement.
Number of exacerbationsBaseline, after 3 months and after 6 monthsSelf-reported through interview and medical records
MortalityAfter 3 months and after 6 monthsLost to follow up because of death
HospitalisationsBaseline, after 3 months and after 6 monthsPrevalence Self-reported through interview and medical records
Incidence of Treatment-Emergent Adverse EventsAfter 3 months and after 6 monthsCancer treatment Self reported through interview and medical records
Postoperative recoveryAfter 3 months and after 6 monthsSelf-reported through interview and medical records
Overall survivalAfter 3 months and after 6 months

Countries

Denmark

Contacts

CONTACTDitte Krag-Hansen, MD, PhD student
ditte.krag-hansen@rsyd.dk+45 7940 5720
CONTACTMorten Hornemann Borg, MD, PhD, Chief consultant
morten.hornemann.borg@rsyd.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026