Enhanced COPD Management in Suspected Lung Cancer Patients

NCT07543601 | Recruiting

• 2 other identifiers: Journal nr.: 25/71Project-ID S-20250091
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Invesigation; Evaluation; Diagnostic Work-up; Diagnostic Pathway

Outcome Measures

Primary Outcomes (1)

• CAT score

  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 Outcomes (13)

• Weight

  Baseline and after 6 months

• Height

  Basline

• BMI

  Baseline and after 6 months

• 1 min sit-to-stand-test

  Baseline and after 6 months

• The ProKOL questionnaire

  Baseline, after 3 months and after 6 months

Study Arms (2)

Usual care

NO INTERVENTION

Lung cancer investigation only

Tailored COPD consultation

EXPERIMENTAL

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

Interventions

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

Tailored COPD consultation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ditte Krag-Hansen: lead
• AstraZeneca: collaborator
• Sygehus Lillebaelt: collaborator

Study Sites (1)

Lung Cancer Investigation Unit, Lillebaelt Hospital Vejle

Vejle, 7100, Denmark

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ditte Krag-Hansen, MD, PhD student

CONTACT

+45 7940 5720; ditte.krag-hansen@rsyd.dk

Morten Hornemann Borg, MD, PhD, Chief consultant

CONTACT

morten.hornemann.borg@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: April 22, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

DK (1)