Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07543601

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

Led by Ditte Krag-Hansen · Updated on 2026-04-22

280

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Ditte Krag-Hansen

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how early diagnosis and optimal treatment of Chronic Obstructive Pulmonary Disease (COPD) affect health outcomes in patients undergoing evaluation for suspected lung cancer. This study highlights the frequent coexistence of COPD and lung cancer, mainly due to shared risk factors like smoking. It aims to improve management of both diseases by focusing on integrated care approaches, potentially enhancing treatment tolerance, reducing complications, and improving overall survival. Participants are randomly assigned to either usual care or tailored COPD consultations following GOLD guidelines. The tailored consultations include pharmacological management, smoking cessation support, pulmonary rehabilitation referrals, nutritional assessment, cardiovascular evaluation, and sleep apnea assessment as needed. This is an open-label randomized controlled trial conducted at the Lung Cancer Investigation Unit at Lillebaelt Hospital Vejle. During the study, participants undergo assessments at baseline, 3 months, and 6 months, including the COPD Assessment Test (CAT) score, weight, height, BMI, 1-minute sit-to-stand test, and questionnaires on health status, anxiety, and depression. Researchers also monitor smoking cessation, exacerbations, hospitalizations, postoperative recovery, mortality, adverse events, and overall survival to evaluate the impact of early COPD management. The total study duration for participants spans 6 months with multiple follow-ups.

CONDITIONS

Brief Title

Enhanced COPD Management in Suspected Lung Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Tailored COPD Consultation

Duration - 6 months

Participants receive tailored COPD consultations including assessment and treatment according to GOLD guidelines, such as pharmacological management, smoking cessation support, and referrals to pulmonary rehabilitation, nutritional, cardiovascular, and sleep apnea evaluations as appropriate.

Visits at baseline, 3 months, and 6 months

Lung Cancer Investigation

Duration - 6 months

Participants undergoing usual lung cancer diagnostic evaluation without additional COPD intervention are observed during their lung cancer work-up.

Visits at baseline, 3 months, and 6 months

Trial Site Locations

Total: 1 location

1

Lung Cancer Investigation Unit, Lillebaelt Hospital Vejle

Vejle, Denmark, 7100

Actively Recruiting

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Research Team

D

Ditte Krag-Hansen, MD, PhD student

M

Morten Hornemann Borg, MD, PhD, Chief consultant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Pulmonary rehabilitation improves exercise capacity, health-related quality of life, and cardiopulmonary function in patients with non-small cell lung cancer.

Chun-Yao Huang, Min-Shiau Hsieh, Po-Chun Hsieh...

https://pubmed.ncbi.nlm.nih.gov/38360680

Effectiveness of Outpatient Pulmonary Rehabilitation in Patients with Surgically Resected Lung Cancer: A Retrospective Real-World Analysis.

Oliver Illini, Arschang Valipour, Dietlinde Gattinger...

https://pubmed.ncbi.nlm.nih.gov/35884540

Chronic obstructive pulmonary disease assessment test for the measurement of deterioration and recovery of health status of patients undergoing lung surgery.

Chun-Yao Huang, Min-Shiau Hsieh, Yao-Kuang Wu...

https://pubmed.ncbi.nlm.nih.gov/34989126

Application of GOLD 2023 Initial Inhalation Therapy Recommendations in COPD patients: a real-world adherence and prognosis analysis.

Dingding Deng, Dan Peng, Qing Song...

https://pubmed.ncbi.nlm.nih.gov/41313168

Optimizing COPD treatment in patients with lung- or head and neck cancer does not improve quality of life - a randomized, pilot, clinical trial.

Magnus Gottlieb, Anders Mellemgaard, Kristoffer Marsaa...

https://pubmed.ncbi.nlm.nih.gov/32194927

Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD.

Trija Vaidya, Claire de Bisschop, Marc Beaumont...

https://pubmed.ncbi.nlm.nih.gov/27799759