COPD, Inflammation and Rehabilitation
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ClinicalTrials.gov Identifier: NCT01700296 |
Recruitment Status :
Completed
First Posted : October 4, 2012
Last Update Posted : April 7, 2017
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Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is like any other with a chronic illness not only affected by the physical discomfort the illness gives. For COPD patients that is: accelerated loss of lung function, conditioning and increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months later.
Patients are also characterized by various psychological factors such as reduced quality of life, depression, etc.
Therefore, everywhere in the country newly diagnosed COPD patients are offered rehabilitation in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a week with physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education based on the National Health Service and international recommendations.
In the literature, the effect of rehabilitation on quality of life was measured using a questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function has been measured using a walk test, but there are no studies which look at the effect on inflammation lungs.
It is important for COPD patients is to prevent exacerbations of the disease, which sometimes requires hospitalization and sometimes treated by their own doctor. It has been proven that inflammation in the lungs is associated with disease severity and exacerbation frequency, and therefore we would like to investigate whether both rehabilitation, close monitoring of patients with time in the pulmonary clinic every 3 months, and instruction in self-administration of medication (antibiotics and corticosteroids) have an effect on especially inflammation in the lungs, number of exacerbations, mortality, lung function and walking capacity.
Condition or disease | Intervention/treatment | Phase |
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COPD | Behavioral: Best care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | COPD, Inflammation and Rehabilitation |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
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No Intervention: Standard Care
"Standard Care": finishing treatment for AECOPD in hospital and after hospital discharge to further control by the GP. In case of severe symptoms and / or airway obstruction (measured by FEV1) refer patients for follow-up in lung clinic. The subjects are recorded with the same subjective, clinical, paraclinical and invasive parameters as the "Best care" group
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Experimental: Best care
"Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through:
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Behavioral: Best care
"Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through:
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- IL-8 in Sputum [ Time Frame: 1 year ]
- IL-8 in serum IL-8 in the BAL fluid [ Time Frame: 1 year ]
- walking distance [ Time Frame: 1 year ]
- exacerbation frequency [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The study includes consecutive patients over 18 years admitted to the Medical dept, Næstved hospital with AECOPD (2 of 3 symptoms: increased breathlessness, sputum or purulens thereof) on the basis of known COPD (post-bronchodilator FEV1 <80% and FEV1/FVC <70% ; measured in stable phase, ie. earlier than 4 weeks after AECOPD). Patients included during hospitalization for AECOPD
Exclusion Criteria:
- Patients can not participate if they have asthma (post-bronchodilator FEV1 increased by> 15%), are pregnant, nursing, has known serious comorbidities (eg cancer, chronic liver cirrhosis or hepatitis) or cannot give informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700296
Denmark | |
Naestved Sygehus | |
Næstved, Denmark, 4700 |
Responsible Party: | Mimi Christiansen, Medical Doctor, Naestved Hospital |
ClinicalTrials.gov Identifier: | NCT01700296 |
Other Study ID Numbers: |
34431 |
First Posted: | October 4, 2012 Key Record Dates |
Last Update Posted: | April 7, 2017 |
Last Verified: | April 2017 |
Inflammation Pathologic Processes |