Predicting outcome using systemic markers In severe exacerbations of chronic obstructive pulmonary disease

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory; Chronic obstructive pulmonary disease, unspecified

• Registration Number: ISRCTN99586989
• Lead Sponsor: niversity Hospital Basel (Switzerland)

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26684757 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29562888

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-16
• Study Completion: 2012-12-31
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Age above 40 years, both men and women
2. Smoking history greater than or equal to 10 pack years
3. Moderate to very severe COPD (Global Initiative for chronic Obstructive Lung Disease [GOLD] II to IV)
4. Currently stable disease (at least 4 weeks after resolution of the last exacerbation)
5. Willingness to participate in a longitudinal, cohort study
6. Willingness of the family physician to have the patient included in a cohort study
7. Written informed consent

Exclusion Criteria

1. Rapid fatal disease
2. Pulmonary condition other than COPD as the main respiratory disease, e.g. bronchiectasis, asthma or pulmonary fibrosis
3. Immunosuppression including human immunodeficiency virus (HIV), organ transplantation or chronic steroid use (more than 10 mg prednisolone-equivalent per day)
4. Patients unable and unwilling to give written informed consent
5. Musculoskeletal process preventing ambulation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical end-points include the following (duration of follow-up: two years): <br>1. Number of exacerbations, including exacerbations requiring hospitalisation and exacerbations managed by the primary care physicians <br>2. Number of deaths of any cause <br>3. Number of respiratory-related deaths <br>4. Time to next exacerbation, time to next exacerbation requiring hospitalisation and time to death <br>5. Duration of hospitalisation <br>6. Admission and length of stay in intensive care unit <br>7. Need for intubation or non-invasive ventilation <br>8. Need for oral steroids and antibiotics <br>9. Lung function and 6-minute walk test changes

Secondary Outcome Measures

Name	Time	Method
1. Quality of life assessed by Saint Georges Respiratory Questionnaire and the 36-item Short Form Health Survey (SF-36) at every scheduled visits during the follow-up phase (every 6 months) and 4 weeks after an exacerbation<br>2. Dyspnea and respiratory symptoms as assessed by the Modified Medical Research Council (MMRC) scale and Lower Respiratory Tract Illness - Visual Analogue Scale (LRTI-VAS) at every scheduled visits during the follow-up phase (every 6 months) and 4 weeks after an exacerbation<br><br>Added 27/10/2010:<br>3. Measurement of daily physicial activity as assessed by a triaxial accelerometer at stable phase of the disease and exacerbation