search
Back to results

COPD, Inflammation and Rehabilitation

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Best care
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Naestved Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Best care

Arm Description

"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

"Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through: 10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25) Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.

Outcomes

Primary Outcome Measures

IL-8 in Sputum

Secondary Outcome Measures

IL-8 in serum IL-8 in the BAL fluid

Full Information

First Posted
October 2, 2012
Last Updated
April 6, 2017
Sponsor
Odense University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01700296
Brief Title
COPD, Inflammation and Rehabilitation
Official Title
COPD, Inflammation and Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
"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
Arm Title
Best care
Arm Type
Experimental
Arm Description
"Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through: 10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25) Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.
Intervention Type
Behavioral
Intervention Name(s)
Best care
Intervention Description
"Best Care": subjects are randomly assigned to the "Best care" regardless MRC class and severity of symptoms through: 10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25) Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters.
Primary Outcome Measure Information:
Title
IL-8 in Sputum
Time Frame
1 year
Secondary Outcome Measure Information:
Title
IL-8 in serum IL-8 in the BAL fluid
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
walking distance
Time Frame
1 year
Title
exacerbation frequency
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Naestved Sygehus
City
Næstved
ZIP/Postal Code
4700
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

COPD, Inflammation and Rehabilitation

We'll reach out to this number within 24 hrs