Condition category
Respiratory
Date applied
29/04/2008
Date assigned
15/05/2008
Last edited
23/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ralf Ewert

ORCID ID

Contact details

Ernst Moritz Arndt University Greifswald
Department of Internal Medicine
Pulmonary Medicine and Infectious Diseases
Friedrich Loeffler Strasse 23a
Greifswald
17489
Germany
ewert@uni-greifswald.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001/2008

Study information

Scientific title

Acronym

CPET in COPD

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

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Exercise variables
2. Lung function data

Primary and secondary outcomes will be assessed at the end of the study.

Secondary outcome measures

GOLD stage, assessed at the end of the study.

Overall trial start date

01/05/2008

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/05/2008

Recruitment end date

30/04/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Ernst Moritz Arndt University Greifswald
Greifswald
17489
Germany

Sponsor information

Organisation

Ambulantes pneumologisches Zentrum GbR (Germany)

Sponsor details

c/o Dr Peter-Uwe Haase
Kleine Marktstrasse 3
Halle
D-06108
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Current funder as of 23/06/2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ambulantes pneumologisches Zentrum GbR (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Previous funder:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Astra Zeneca GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes