Chronic Obstructive Pulmonary DiseasePhase 4NCT00857038
Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Doxycycline in people with Chronic Obstructive Pulmonary Disease and Inflammation, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial summary
COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Inflammation, Pulmonary Emphysema
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2009to Jan 2010
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GOLD II or III COPD (GOLD II: FEV1/FVC < 70%; 50% < FEV1 < 80% predicted, GOLD III: FEV1/FVC < 70%; 30% < FEV1 < 50% predicted ).
- Stable disease (no exacerbations in the last 3 months).
- Age > 40 yrs.
- Written informed consent.
Who cannot join
- Infections and/or use of antibiotics in the last month.
- Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL).
- Allergy for tetracyclines or a history of substantial side-effects.
- Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).
- Acute exacerbation of COPD as defined by Anthonisen et al. [10].
- Signs and/or symptoms of a current respiratory or non-respiratory infection.
- Use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Center Alkmaar
Alkmaar, North Holland, 1815JD
Wim G Boersma, MD, 0031725482750, w.boersma@mca.nl
About this study
Official title: Doxycycline and Airway Inflammation in COPD: A Randomised Placebo Controlled Trial Studying the Effects of Doxycycline on Airway Inflammation in Patients With Moderate and Severe Stable COPD.
COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.
Read the detailed description
Rationale:
COPD is a disease characterized by chronic inflammation and irreversible airway obstruction. Chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. Tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis.
Objective:
To assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable GOLD II and III COPD patients.
Study population:
Thirty patients with stable GOLD II COPD.
Intervention:
Placebo versus doxycycline in randomised design.
- Being tested
- Doxycycline, Placebo
- Keywords
- COPD, Inflammation, Neutrophilic, Myeloperoxidase, Doxycycline
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline tablets, 100mg daily
PlaceboDrug
Placebo tablets 100mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Doxycycline 100mg daily Receives: Drug: Doxycycline |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
myeloperoxidase in induced sputum
Measured: 3 weeks
Secondary outcomes (3)
MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.
Measured: 3 weeks
Lung function (FEV1)
Measured: 3 weeks
Symptom scores
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009 (estimated)
- Study completionJan 2010 (estimated)
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857038
- Sponsor's protocol ID
- M07-046
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Prins HJ, Daniels JM, Lindeman JH, Lutter R, Boersma WG. Effects of doxycycline on local and systemic inflammation in stable COPD patients, a randomized clinical trial. Respir Med. 2016 Jan;110:46-52. doi: 10.1016/j.rmed.2015.10.009. Epub 2015 Oct 30.
PubMed 26616678
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline and Airway Inflammation in COPD: A Randomised Placebo Controlled Trial Studying the Effects of Doxycycline on Airway Inflammation in Patients With Moderate and Severe Stable COPD.
- ClinicalTrials.gov ID
- NCT00857038
- Acronym / sponsor ID
- M07-046
- Keywords
- COPD, Inflammation, Neutrophilic, Myeloperoxidase, Doxycycline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, University of Amsterdam
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 6 Mar 2009 (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.
COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.
Detailed description
Rationale:
COPD is a disease characterized by chronic inflammation and irreversible airway obstruction. Chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. Tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis.
Objective:
To assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable GOLD II and III COPD patients.
Study population:
Thirty patients with stable GOLD II COPD.
Intervention:
Placebo versus doxycycline in randomised design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DoxycyclineDoxycycline 100mg daily |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- GOLD II or III COPD (GOLD II: FEV1/FVC < 70%; 50% < FEV1 < 80% predicted, GOLD III: FEV1/FVC < 70%; 30% < FEV1 < 50% predicted ).
- Stable disease (no exacerbations in the last 3 months).
- Age > 40 yrs.
- Written informed consent.
Key exclusion criteria (7 listed)
- Infections and/or use of antibiotics in the last month.
- Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL).
- Allergy for tetracyclines or a history of substantial side-effects.
- Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).
- Acute exacerbation of COPD as defined by Anthonisen et al. [10].
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 |
|---|---|---|
| DoxycyclineDoxycycline tablets, 100mg daily | Drug | 1 |
| PlaceboPlacebo tablets 100mg | Drug | 2 |
Primary outcome
myeloperoxidase in induced sputum
Time frame: 3 weeks
3 secondary outcomes
MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.
Time frame: 3 weeks
Lung function (FEV1)
Time frame: 3 weeks
Symptom scores
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
- Derived from this study: PubMed 26616678Prins HJ, Daniels JM, Lindeman JH, Lutter R, Boersma WG. Effects of doxycycline on local and systemic inflammation in stable COPD patients, a randomized clinical trial. Respir Med. 2016 Jan;110:46-52. doi: 10.1016/j.rmed.2015.10.009. Epub 2015 Oct 30.
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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.
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 and Inflammation, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Mar 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wim G Boersma, MD (0031725482750, w.boersma@mca.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myeloperoxidase in induced sputum (time frame: 3 weeks). 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 NCT00857038, 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 6 Mar 2009.