Chronic Obstructive Pulmonary DiseasePhase 4NCT00311961
Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Intravenous prednisolone and Oral prednisolone in people with Chronic Obstructive Pulmonary Disease, run by Isala at 1 site in Netherlands.
Trial summary
Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Intravenous prednisolone and Oral prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 256 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2001to Aug 2003
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease [GOLD] severity stage II)
- Smoking history of > 10 pack years
Who cannot join
- Signs of severe exacerbation (arterial pH < 7.26 or pCO2 > 9.3 kPa)
- History of asthma
- Significant or unstable co-morbidity
- Participated in another study 4 weeks before admission
- Previously randomized to this study
- Findings on chest radiography other than those fitting with signs of COPD
- Known hypersensitivity to prednisolone
- Non-compliant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller.
The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Intravenous prednisolone, Oral prednisolone
- Keywords
- COPD, Exacerbations, Corticosteroids, Oral, Intravenous, Chronic Obstructive Pulmonary Disease (COPD)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous prednisoloneDrug
Oral prednisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure defined as: death from any cause
admission to the intensive care unit
readmission to the hospital because of COPD
and the necessity to intensify pharmacologic treatment
Secondary outcomes (4)
Changes in forced expiratory volume in 1 second (FEV1)
St. George's Respiratory Questionnaire (SGRQ) scores
Clinical COPD Questionnaire (CCQ) scores
and length of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startJun 2001
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 256 participants
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Investigators
- Jan WK van den Berg, MD, PhD, Principal investigator, IsalaYnze P de Jong, MD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311961
- Sponsor's protocol ID
- IK-001
- Status last verified
- Aug 2009
- First submitted
- 5 Apr 2006
- Last updated
- 26 Aug 2009
- Results posted
- No
Publications
de Jong YP, Uil SM, Grotjohan HP, Postma DS, Kerstjens HA, van den Berg JW. Oral or IV prednisolone in the treatment of COPD exacerbations: a randomized, controlled, double-blind study. Chest. 2007 Dec;132(6):1741-7. doi: 10.1378/chest.07-0208. Epub 2007 Jul 23.
PubMed 17646228
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00311961
- Acronym / sponsor ID
- IK-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Exacerbations, Corticosteroids, Oral, Intravenous, Chronic Obstructive Pulmonary Disease (COPD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 7 Apr 2006 (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.
Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller.
The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease [GOLD] severity stage II)
- Smoking history of > 10 pack years
Key exclusion criteria (8 listed)
- Signs of severe exacerbation (arterial pH < 7.26 or pCO2 > 9.3 kPa)
- History of asthma
- Significant or unstable co-morbidity
- Participated in another study 4 weeks before admission
- Previously randomized to this study
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 |
|---|---|---|
| Intravenous prednisolone | Drug | – |
| Oral prednisolone | Drug | – |
Primary outcome
Treatment failure defined as: death from any cause
admission to the intensive care unit
readmission to the hospital because of COPD
and the necessity to intensify pharmacologic treatment
4 secondary outcomes
Changes in forced expiratory volume in 1 second (FEV1)
St. George's Respiratory Questionnaire (SGRQ) scores
Clinical COPD Questionnaire (CCQ) scores
and length of hospital stay
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 26 Aug 2009.
- Derived from this study: PubMed 17646228de Jong YP, Uil SM, Grotjohan HP, Postma DS, Kerstjens HA, van den Berg JW. Oral or IV prednisolone in the treatment of COPD exacerbations: a randomized, controlled, double-blind study. Chest. 2007 Dec;132(6):1741-7. doi: 10.1378/chest.07-0208. Epub 2007 Jul 23.
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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.
Jan WK van den Berg, MD, PhD principal investigator
Isala
Ynze P de Jong, MD principal investigator
Isala
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 Intravenous prednisolone and Oral prednisolone in people with Chronic Obstructive Pulmonary Disease, run by Isala at 1 site in Netherlands.
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 2 inclusion and 8 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 26 Aug 2009. 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 Netherlands. 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. 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?
Treatment failure defined as: death from any cause. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311961, which also lists 1 linked publication.
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 26 Aug 2009.