Chronic Obstructive Pulmonary DiseasePhase 2NCT00239278
Budesonide / Formoterol in Treatment of Exacerbations of COPD
A Phase 2 study testing budesonide/formoterol, 2x 200/6 microgram. 4 times daily in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy 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?
- budesonide/formoterol, 2x 200/6 microgram. 4 times daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2001to Jan 2005
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- smoking-induced COPD according to ATS criteria
- FEV1 <85% of predicted at enrolment and <70% of predicted but > 0.7 Liter at Exacerbation
- FEV1/IVC ratio <88% of predicted for men and <89% for women
Who cannot join
- history of asthma
- known hypersensitivity to the study drugs
- serious concomitant diseases
- pregnancy or lactating
- abnormal Chest X-ray or blood gasses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Dose Inhaled Budesonide+ Formoterol Versus Placebo and Oral Prednisolone on Biomarkers of Airway Inflammation in the Treatment of Exacerbations in Non-hospitalised Patients With Mild to Moderate COPD.
The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- budesonide/formoterol, 2x 200/6 microgram. 4 times daily, prednisolone, 30 mg once daily and placebo
- 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.
budesonide/formoterol, 2x 200/6 microgram. 4 times dailyDrug
Also called Symbicort
prednisolone, 30 mg once daily and placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
Secondary outcomes (5)
Inflammatory markers in induced sputum, blood/serum and urine
Lung function tests at clinic
Diary cards for PEF and symptoms
Patient Related outcomes
Questioning for Adverse Events and in blood: routine tests and cortisol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJan 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Netherlands Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239278
- Sponsor's protocol ID
- SD-039-0698
- Other IDs
- D5892C00698
- Status last verified
- Jan 2011
- First submitted
- 13 Oct 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
Bathoorn E, Liesker JJ, Postma DS, Boorsma M, Bondesson E, Koeter GH, Kauffman HF, van Oosterhout AJ, Kerstjens HA. Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations. COPD. 2008 Oct;5(5):282-90. doi: 10.1080/15412550802363360.
PubMed 18972276Bathoorn E, Liesker J, Postma D, Koeter G, van Oosterhout AJ, Kerstjens HA. Safety of sputum induction during exacerbations of COPD. Chest. 2007 Feb;131(2):432-8. doi: 10.1378/chest.06-2216.
PubMed 17296644
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Dose Inhaled Budesonide+ Formoterol Versus Placebo and Oral Prednisolone on Biomarkers of Airway Inflammation in the Treatment of Exacerbations in Non-hospitalised Patients With Mild to Moderate COPD.
- ClinicalTrials.gov ID
- NCT00239278
- Acronym / sponsor ID
- SD-039-0698
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- Jan 2005 (actual)
- First posted
- 17 Oct 2005 (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 purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- smoking-induced COPD according to ATS criteria
- FEV1 <85% of predicted at enrolment and <70% of predicted but > 0.7 Liter at Exacerbation
- FEV1/IVC ratio <88% of predicted for men and <89% for women
Key exclusion criteria (5 listed)
- history of asthma
- known hypersensitivity to the study drugs
- serious concomitant diseases
- pregnancy or lactating
- abnormal Chest X-ray or blood gasses
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 |
|---|---|---|
| budesonide/formoterol, 2x 200/6 microgram. 4 times dailyAlso: Symbicort | Drug | – |
| prednisolone, 30 mg once daily and placebo | Drug | – |
Primary outcome
Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
5 secondary outcomes
Inflammatory markers in induced sputum, blood/serum and urine
Lung function tests at clinic
Diary cards for PEF and symptoms
Patient Related outcomes
Questioning for Adverse Events and in blood: routine tests and cortisol
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 24 Jan 2011.
- Derived from this study: PubMed 18972276Bathoorn E, Liesker JJ, Postma DS, Boorsma M, Bondesson E, Koeter GH, Kauffman HF, van Oosterhout AJ, Kerstjens HA. Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations. COPD. 2008 Oct;5(5):282-90. doi: 10.1080/15412550802363360.
- Derived from this study: PubMed 17296644Bathoorn E, Liesker J, Postma D, Koeter G, van Oosterhout AJ, Kerstjens HA. Safety of sputum induction during exacerbations of COPD. Chest. 2007 Feb;131(2):432-8. doi: 10.1378/chest.06-2216.
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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.
AstraZeneca Netherlands Medical Director, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing budesonide/formoterol, 2x 200/6 microgram. 4 times daily in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca 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 3 inclusion and 5 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 24 Jan 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment. 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 NCT00239278, which also lists 2 linked publications.
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 24 Jan 2011.