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25 July 2008
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| [ Print-friendly version ] |
| CardioPulmonary Exercise Testing in patients with Chronic Obstructive Pulmonary Disease |
| ISRCTN | ISRCTN22314061 |
| ClinicalTrials.gov identifier | |
| Public title | CardioPulmonary Exercise Testing in patients with Chronic Obstructive Pulmonary Disease |
| Scientific title | |
| Acronym | CPET in COPD |
| Serial number at source | 001/2008 |
| Study hypothesis |
1. Gas exchange data assessed by cardiopulmonary exercise testing (CPET) will provide profound prognostic and clinically relevant data to sub-classify patients with severe chronic obstructive pulmonary disease (COPD)
2. Different predefined standardised exercise protocols won’t show relevant differences concerning CPET results in the assessment of COPD patients Please note that as of 23/06/2008 the funder and sponsor of this trial was changed to Ambulantes pneumologisches Zentrum GbR (Germany). Previous sponsor details can be found under the interventions section. |
| Ethics approval | Ethics approval received from the Ethics Committee of the Ernst Moritz Arndt University of Greifswald on the 31st July 2007 (ref: BB48/07). |
| Study design | Observational study of consecutive patients |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Chronic obstructive pulmonary disease (COPD) |
| Participants - inclusion criteria |
1. Diagnosis of COPD (according to American Thoracic Society [ATS] case definition) meeting all necessary criteria to be classified as Global Initiative for chronic Obstructive Lung Disease (GOLD) III and IV
2. Informed consent for study-related procedure 3. Stable medications for the last two weeks 4. Ability to safely perform the CPET without contraindications 5. Aged 18 - 80 years, both genders |
| Participants - exclusion criteria |
1. Existing contraindication for exercise test
2. Patients with clinically relevant congestive heart failure or other diseases which may influence the results of the study (e.g. handicaps) 3. Exacerbation of COPD within the last two weeks before CPET 4. Conditions associated with poor compliance 5. Patients who have participated in a clinical study within the last four weeks |
| Anticipated start date | 01/05/2008 |
| Anticipated end date | 30/04/2009 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
Patients suffering from COPD (according to the GOLD criteria classified as stage III and IV) will undergo CPET according to a standardised exercise protocol. In addition to the previous obtained spirometric and bodyplethysmographic data, a number of CPET data will be investigated.
Based on this CPET data the aim of the study is to sub-classify patients into clinical and prognostic groups. The data of gas exchange during exercise might provide further insights in the exercise limiting disease related factors. The impact of the data might result in a new sub-classification of patients with severe COPD. Previous sponsor prior to 23/06/2008: Astra Zeneca GmbH (Germany) Tindsdaler Weg 183 Wedel, D-22880 Germany |
| Primary outcome measure(s) |
1. Exercise variables
2. Lung function data Primary and secondary outcomes will be assessed at the end of the study. |
| Secondary outcome measure(s) | GOLD stage, assessed at the end of the study. |
| Sources of funding |
Current funder as of 23/06/2008:
Ambulantes pneumologisches Zentrum GbR (Germany) Previous funder: Astra Zeneca GmbH (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Ralf Ewert |
| Address |
Ernst Moritz Arndt University Greifswald
Department of Internal Medicine Pulmonary Medicine and Infectious Diseases Friedrich Loeffler Strasse 23a |
| City/town | Greifswald |
| Zip/Postcode | 17489 |
| Country | Germany |
| ewert@uni-greifswald.de | |
| Sponsor | Ambulantes pneumologisches Zentrum GbR (Germany) |
| Address |
c/o Dr Peter-Uwe Haase
Kleine Marktstrasse 3 |
| City/town | Halle |
| Zip/Postcode | D-06108 |
| Country | Germany |
| Date applied | 29/04/2008 |
| Last edited | 23/06/2008 |
| Date ISRCTN assigned | 15/05/2008 |
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