COPD (Chronic Obstructive Pulmonary Disease)ECHELONNCT07543601
Enhanced COPD Management in Suspected Lung Cancer Patients
A study testing Tailored COPD consultations in people with COPD (Chronic Obstructive Pulmonary Disease) and Lung Cancer (Diagnosis), run by Ditte Krag-Hansen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Lung Cancer (Diagnosis), Lung Neoplasm Malignant
- What is being tested?
- Tailored COPD consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of significant comorbidities that may interfere with diagnostic procedures or spirometry
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Morten Hornemann Borg, MD, PhD, Chief consultant contact
Denmark1 site, 1 recruiting
- Recruiting
Lung Cancer Investigation Unit, Lillebaelt Hospital Vejle
Vejle, 7100
Ditte Krag-Hansen, MD, PhD student, +45 7940 5720, ditte.krag-hansen@rsyd.dk
Morten Hornemann Borg, MD, PhD, Chief consultant
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Lung Cancer (Diagnosis), Lung Neoplasm Malignant, Lung Carcinoma, Pulmonary Neoplasms, Pulmonary Neoplasm
- Being tested
- Tailored COPD consultations
- Keywords
- Invesigation, Evaluation, Diagnostic Work-up, Diagnostic Pathway
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored COPD consultationsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Tailored COPD consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 3 months and after 6 months
Secondary outcomes (13)
Weight
kg Reviews the change
Measured: Baseline and after 6 months
Height
cm
Measured: Basline
BMI
kg/m^2 Reviews the change
Measured: Baseline and after 6 months
1 min sit-to-stand-test
The higher the number the better
Measured: Baseline and after 6 months
The ProKOL questionnaire
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
Measured: Baseline, after 3 months and after 6 months
The HADS questionnaire
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
Measured: Baseline, after 3 months and after 6 months
Smoking cessation
Self-reported through interview. Attempts at cessation, succeeded cessation or more motivated to cessation are perceived as an improvement.
Measured: Baseline, after 3 months and after 6 months
Number of exacerbations
Self-reported through interview and medical records
Measured: Baseline, after 3 months and after 6 months
Mortality
Lost to follow up because of death
Measured: After 3 months and after 6 months
Hospitalisations
Prevalence Self-reported through interview and medical records
Measured: Baseline, after 3 months and after 6 months
Incidence of Treatment-Emergent Adverse Events
Cancer treatment Self reported through interview and medical records
Measured: After 3 months and after 6 months
Postoperative recovery
Self-reported through interview and medical records
Measured: After 3 months and after 6 months
Overall survival
Measured: After 3 months and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start6 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ditte Krag-Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Sygehus Lillebaelt
- Responsible party
- Sponsor-investigator, Ditte Krag-Hansen, Region of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543601
- Sponsor's protocol ID
- Journal nr.: 25/71
- Other IDs
- Project-ID S-20250091
- Acronym
- ECHELON
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Huang CY, Hsieh MS, Hsieh PC, Wu YK, Yang MC, Huang SY, Tzeng IS, Lan CC. Pulmonary rehabilitation improves exercise capacity, health-related quality of life, and cardiopulmonary function in patients with non-small cell lung cancer. BMC Cancer. 2024 Feb 15;24(1):211. doi: 10.1186/s12885-024-11977-5.
PubMed 38360680Vagvolgyi A, Rozgonyi Z, Kerti M, Vadasz P, Varga J. Effectiveness of perioperative pulmonary rehabilitation in thoracic surgery. J Thorac Dis. 2017 Jun;9(6):1584-1591. doi: 10.21037/jtd.2017.05.49.
PubMed 28740672Shin S, Kong S, Kang D, Lee G, Cho JH, Shim YM, Cho J, Kim HK, Park HY. Longitudinal changes in pulmonary function and patient-reported outcomes after lung cancer surgery. Respir Res. 2022 Aug 30;23(1):224. doi: 10.1186/s12931-022-02149-9.
PubMed 36042472Illini O, Valipour A, Gattinger D, Petrovic M, Fabikan H, Hochmair MJ, Zwick RH. Effectiveness of Outpatient Pulmonary Rehabilitation in Patients with Surgically Resected Lung Cancer: A Retrospective Real-World Analysis. Cancers (Basel). 2022 Jul 18;14(14):3479. doi: 10.3390/cancers14143479.
PubMed 35884540Huang CY, Hsieh MS, Wu YK, Hsieh PC, Yang MC, Tzeng IS, Lan CC. Chronic obstructive pulmonary disease assessment test for the measurement of deterioration and recovery of health status of patients undergoing lung surgery. Thorac Cancer. 2022 Feb;13(4):613-623. doi: 10.1111/1759-7714.14306. Epub 2022 Jan 6.
PubMed 34989126Deng D, Peng D, Song Q, Lin L, Liu C, Li T, Zhang P, Zeng Y, Lei S, Chen P. Application of GOLD 2023 Initial Inhalation Therapy Recommendations in COPD patients: a real-world adherence and prognosis analysis. J Glob Health. 2025 Nov 28;15:04324. doi: 10.7189/jogh.15.04324.
PubMed 41313168Zhou R, Qin Y, Hu S, Xu Y, Feng C. Effect of dual bronchodilators plus preoperative rehabilitation in operable LC & chronic obstructive pulmonary disease. Future Oncol. 2024 Dec;20(40):3471-3476. doi: 10.1080/14796694.2024.2430164. Epub 2024 Nov 28.
PubMed 39607005Gottlieb M, Mellemgaard A, Marsaa K, Godtfredsen N. Optimizing COPD treatment in patients with lung- or head and neck cancer does not improve quality of life - a randomized, pilot, clinical trial. Eur Clin Respir J. 2020 Mar 2;7(1):1731277. doi: 10.1080/20018525.2020.1731277. eCollection 2020.
PubMed 32194927Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. 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. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.
PubMed 27799759Jones PW, Harding G, Wiklund I, Berry P, Tabberer M, Yu R, Leidy NK. Tests of the responsiveness of the COPD assessment test following acute exacerbation and pulmonary rehabilitation. Chest. 2012 Jul;142(1):134-140. doi: 10.1378/chest.11-0309.
PubMed 22281796Bolukbas S, Eberlein M, Eckhoff J, Schirren J. Short-term effects of inhalative tiotropium/formoterol/budenoside versus tiotropium/formoterol in patients with newly diagnosed chronic obstructive pulmonary disease requiring surgery for lung cancer: a prospective randomized trial. Eur J Cardiothorac Surg. 2011 Jun;39(6):995-1000. doi: 10.1016/j.ejcts.2010.09.025. Epub 2010 Oct 22.
PubMed 20970351Makino T, Otsuka H, Hata Y, Koezuka S, Azuma Y, Isobe K, Sugino K, Ebihara S, Homma S, Iyoda A. Long-acting muscarinic antagonist and long-acting beta2-agonist therapy to optimize chronic obstructive pulmonary disease prior to lung cancer surgery. Mol Clin Oncol. 2018 May;8(5):647-652. doi: 10.3892/mco.2018.1595. Epub 2018 Mar 26.
PubMed 29725530Andre S, Conde B, Fragoso E, Boleo-Tome JP, Areias V, Cardoso J; GI DPOC-Grupo de Interesse na Doenca Pulmonar Obstrutiva Cronica. COPD and Cardiovascular Disease. Pulmonology. 2019 May-Jun;25(3):168-176. doi: 10.1016/j.pulmoe.2018.09.006. Epub 2018 Dec 7.
PubMed 30527374Negewo NA, Gibson PG, McDonald VM. COPD and its comorbidities: Impact, measurement and mechanisms. Respirology. 2015 Nov;20(8):1160-71. doi: 10.1111/resp.12642. Epub 2015 Sep 16.
PubMed 26374280
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced COPD Management in Suspected Lung Cancer Patients - Improving Outcomes Through Timely Intervention
- ClinicalTrials.gov ID
- NCT07543601
- Acronym / sponsor ID
- ECHELON / Journal nr.: 25/71
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Lung Cancer (Diagnosis), Lung Neoplasm Malignant, Lung Carcinoma, Pulmonary Neoplasms, Pulmonary Neoplasm
- Keywords
- Invesigation, Evaluation, Diagnostic Work-up, Diagnostic Pathway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ditte Krag-HansenUniversity, hospital or other
- Collaborators
- AstraZeneca, Sygehus Lillebaelt
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Lung cancer investigation only |
| Tailored COPD consultation | Experimental | Other: Tailored COPD consultationsTailored 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of significant comorbidities that may interfere with diagnostic procedures or spirometry
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored COPD consultationsThese 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 consultation |
Primary outcome
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.
13 secondary outcomes
Weight
Time frame: Baseline and after 6 months
Height
Time frame: Basline
BMI
Time frame: Baseline and after 6 months
1 min sit-to-stand-test
Time frame: Baseline and after 6 months
The ProKOL questionnaire
Time frame: Baseline, after 3 months and after 6 months
The HADS questionnaire
Time frame: Baseline, after 3 months and after 6 months
Smoking cessation
Time frame: Baseline, after 3 months and after 6 months
Number of exacerbations
Time frame: Baseline, after 3 months and after 6 months
Mortality
Time frame: After 3 months and after 6 months
Hospitalisations
Time frame: Baseline, after 3 months and after 6 months
Incidence of Treatment-Emergent Adverse Events
Time frame: After 3 months and after 6 months
Postoperative recovery
Time frame: After 3 months and after 6 months
Overall survival
Time frame: After 3 months and after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 38360680Huang CY, Hsieh MS, Hsieh PC, Wu YK, Yang MC, Huang SY, Tzeng IS, Lan CC. Pulmonary rehabilitation improves exercise capacity, health-related quality of life, and cardiopulmonary function in patients with non-small cell lung cancer. BMC Cancer. 2024 Feb 15;24(1):211. doi: 10.1186/s12885-024-11977-5.
- Background: PubMed 28740672Vagvolgyi A, Rozgonyi Z, Kerti M, Vadasz P, Varga J. Effectiveness of perioperative pulmonary rehabilitation in thoracic surgery. J Thorac Dis. 2017 Jun;9(6):1584-1591. doi: 10.21037/jtd.2017.05.49.
- Background: PubMed 36042472Shin S, Kong S, Kang D, Lee G, Cho JH, Shim YM, Cho J, Kim HK, Park HY. Longitudinal changes in pulmonary function and patient-reported outcomes after lung cancer surgery. Respir Res. 2022 Aug 30;23(1):224. doi: 10.1186/s12931-022-02149-9.
- Background: PubMed 35884540Illini O, Valipour A, Gattinger D, Petrovic M, Fabikan H, Hochmair MJ, Zwick RH. Effectiveness of Outpatient Pulmonary Rehabilitation in Patients with Surgically Resected Lung Cancer: A Retrospective Real-World Analysis. Cancers (Basel). 2022 Jul 18;14(14):3479. doi: 10.3390/cancers14143479.
- Background: PubMed 34989126Huang CY, Hsieh MS, Wu YK, Hsieh PC, Yang MC, Tzeng IS, Lan CC. Chronic obstructive pulmonary disease assessment test for the measurement of deterioration and recovery of health status of patients undergoing lung surgery. Thorac Cancer. 2022 Feb;13(4):613-623. doi: 10.1111/1759-7714.14306. Epub 2022 Jan 6.
- Background: PubMed 41313168Deng D, Peng D, Song Q, Lin L, Liu C, Li T, Zhang P, Zeng Y, Lei S, Chen P. Application of GOLD 2023 Initial Inhalation Therapy Recommendations in COPD patients: a real-world adherence and prognosis analysis. J Glob Health. 2025 Nov 28;15:04324. doi: 10.7189/jogh.15.04324.
- Background: PubMed 39607005Zhou R, Qin Y, Hu S, Xu Y, Feng C. Effect of dual bronchodilators plus preoperative rehabilitation in operable LC & chronic obstructive pulmonary disease. Future Oncol. 2024 Dec;20(40):3471-3476. doi: 10.1080/14796694.2024.2430164. Epub 2024 Nov 28.
- Background: PubMed 32194927Gottlieb M, Mellemgaard A, Marsaa K, Godtfredsen N. Optimizing COPD treatment in patients with lung- or head and neck cancer does not improve quality of life - a randomized, pilot, clinical trial. Eur Clin Respir J. 2020 Mar 2;7(1):1731277. doi: 10.1080/20018525.2020.1731277. eCollection 2020.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 27799759Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. 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. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.
- Background: PubMed 22281796Jones PW, Harding G, Wiklund I, Berry P, Tabberer M, Yu R, Leidy NK. Tests of the responsiveness of the COPD assessment test following acute exacerbation and pulmonary rehabilitation. Chest. 2012 Jul;142(1):134-140. doi: 10.1378/chest.11-0309.
- Background: PubMed 20970351Bolukbas S, Eberlein M, Eckhoff J, Schirren J. Short-term effects of inhalative tiotropium/formoterol/budenoside versus tiotropium/formoterol in patients with newly diagnosed chronic obstructive pulmonary disease requiring surgery for lung cancer: a prospective randomized trial. Eur J Cardiothorac Surg. 2011 Jun;39(6):995-1000. doi: 10.1016/j.ejcts.2010.09.025. Epub 2010 Oct 22.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Morten Hornemann Borg, MD, PhD, Chief consultant contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored COPD consultations in people with COPD (Chronic Obstructive Pulmonary Disease) and Lung Cancer (Diagnosis), run by Ditte Krag-Hansen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ditte Krag-Hansen, MD, PhD student (+45 7940 5720, ditte.krag-hansen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAT score (time frame: Baseline, after 3 months and after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07543601, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.