Exercise Performance in Copd PatientsPhase 4COPDpredNCT01978665
The Effect of Prednisone on Physical Exercise in COPD Patients
A Phase 4 study testing prednisone in people with Exercise Performance in Copd Patients, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(COPD) Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Exercise Performance in Copd Patients
- What is being tested?
- prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to use a ergometer bike
- Exclusion Criteria: Haemodynamicaly unstable heart conditions
- exacerbations before 6 week entry of the study exacerbation during the study period treatment with beta blockers malignancy the last 5 years allergi toward IMP
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis.
The objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(COPD)
Read the detailed description
RCT study with 4 days of steroid
- Conditions
- Exercise Performance in Copd Patients
- Being tested
- prednisone
- Keywords
- COPD exercise inflammation prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
Also called placebo
similar size tablets
| Study group | Role | What they receive |
|---|---|---|
| prednisone and Solumedrol | Placebo comparator | placebo arm versus prednisone Receives: Drug: prednisone |
| solumedrol | Placebo comparator | placebo versus solu medrol Receives: Drug: prednisone |
| placebo | Other | measurement of fitness Receives: Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on muscle power
muscular strenght
Measured: jan 2013 to july 2013 (6 months)
Secondary outcomes (1)
the inflammatory response
hsCRP
Measured: jan 2013 to july 2013 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Performance in Copd PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT study with steroid.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vibeke Backer, Bispebjerg Hospital
- Investigators
- Vibeke Backer, professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978665
- Sponsor's protocol ID
- 2012-004503-13
- Other IDs
- 2012-004503-13
- Acronym
- COPDpred
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 2013
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis.
- ClinicalTrials.gov ID
- NCT01978665
- Acronym / sponsor ID
- COPDpred / 2012-004503-13
- Conditions
- Exercise Performance in Copd Patients
- Keywords
- COPD exercise inflammation prednisone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(COPD)
Detailed description
RCT study with 4 days of steroid
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- RCT study with steroid.
| Arm | Type | Receives |
|---|---|---|
| prednisone and Solumedrol | Placebo comparator | Drug: prednisoneplacebo arm versus prednisone |
| solumedrol | Placebo comparator | Drug: prednisoneplacebo versus solu medrol |
| placebo | Other | Drug: prednisonemeasurement of fitness |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to use a ergometer bike
- Exclusion Criteria: Haemodynamicaly unstable heart conditions
- exacerbations before 6 week entry of the study exacerbation during the study period treatment with beta blockers malignancy the last 5 years allergi toward IMP
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisoneAlso: placebosimilar size tablets | Drug | placebo, prednisone and Solumedrol, solumedrol |
Primary outcome
effect on muscle power
Time frame: jan 2013 to july 2013 (6 months)
muscular strenght
1 secondary outcome
the inflammatory response
Time frame: jan 2013 to july 2013 (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for Exercise Performance in Copd Patients
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High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease
Chronic Respiratory Disease, Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Acute Effects of Inspiratory Muscle Training on Peripheral Muscle Metabolism and Autonomic Response in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD
COPD, Hyperinflation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke Backer, professor principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prednisone in people with Exercise Performance in Copd Patients, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on muscle power (time frame: jan 2013 to july 2013 (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.