Chronic Obstructive Pulmonary DiseasePhase 4NCT00170222
Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing doxycycline in people with Chronic Obstructive Pulmonary Disease, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial summary
The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- doxycycline
- How many people
- 258 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2002to Aug 2008
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute exacerbation of COPD type I or II according to GOLD
- Ability to perform lung function tests
- Ability to take oral medication
Who cannot join
- Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
- Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation.
- Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation.
- Progression or new radiographic abnormalities on the chest X-ray.
- Severe exacerbation that required mechanical ventilation.
- History of bronchiectasis
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- Recent or unresolved lung malignancy.
- Other disease likely to require antibiotic therapy.
- Significant gastrointestinal or other conditions that may affect study drug absorption.
- Class III or IV congestive heart failure or stroke.
- Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).
- Cystic fibrosis
- Tuberculosis.
- Impaired renal function (creatinine clearance < 20 ml/min).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients
The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.
The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- doxycycline
- Keywords
- Acute bronchitis, antibiotics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy at the end of treatment
Secondary outcomes (2)
Treatment failure at follow up
Number of exacerbation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionAug 2008
- Study completionAug 2008
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.
- 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
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Investigators
- Johannes MA Daniels, drs, Principal investigator, Pulmo ScienceDominic Snijders, drs, Principal investigator, Pulmo Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170222
- Sponsor's protocol ID
- M02-007
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2005
- Last updated
- 29 Sep 2008
- Results posted
- No
Publications
Daniels JM, Schoorl M, Snijders D, Knol DL, Lutter R, Jansen HM, Boersma WG. Procalcitonin vs C-reactive protein as predictive markers of response to antibiotic therapy in acute exacerbations of COPD. Chest. 2010 Nov;138(5):1108-15. doi: 10.1378/chest.09-2927. Epub 2010 Jun 24.
PubMed 20576731Daniels JM, Snijders D, de Graaff CS, Vlaspolder F, Jansen HM, Boersma WG. Antibiotics in addition to systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Jan 15;181(2):150-7. doi: 10.1164/rccm.200906-0837OC. Epub 2009 Oct 29.
PubMed 19875685
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients
- ClinicalTrials.gov ID
- NCT00170222
- Acronym / sponsor ID
- M02-007
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Acute bronchitis, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Sep 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 role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.
The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute exacerbation of COPD type I or II according to GOLD
- Ability to perform lung function tests
- Ability to take oral medication
Key exclusion criteria (14 listed)
- Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
- Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation.
- Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation.
- Progression or new radiographic abnormalities on the chest X-ray.
- Severe exacerbation that required mechanical ventilation.
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 |
|---|---|---|
| doxycycline | Drug | – |
Primary outcome
Clinical efficacy at the end of treatment
2 secondary outcomes
Treatment failure at follow up
Number of exacerbation
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 29 Sep 2008.
- Derived from this study: PubMed 20576731Daniels JM, Schoorl M, Snijders D, Knol DL, Lutter R, Jansen HM, Boersma WG. Procalcitonin vs C-reactive protein as predictive markers of response to antibiotic therapy in acute exacerbations of COPD. Chest. 2010 Nov;138(5):1108-15. doi: 10.1378/chest.09-2927. Epub 2010 Jun 24.
- Derived from this study: PubMed 19875685Daniels JM, Snijders D, de Graaff CS, Vlaspolder F, Jansen HM, Boersma WG. Antibiotics in addition to systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Jan 15;181(2):150-7. doi: 10.1164/rccm.200906-0837OC. Epub 2009 Oct 29.
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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.
Johannes MA Daniels, drs principal investigator
Pulmo Science
Dominic Snijders, drs principal investigator
Pulmo Science
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 doxycycline in people with Chronic Obstructive Pulmonary Disease, run by Medical Center Alkmaar 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 14 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 29 Sep 2008. 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?
Clinical efficacy at the end of 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 NCT00170222, 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 29 Sep 2008.