- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00857038
Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Wim G Boersma, MD
- Phone Number: 0031725482750
- Email: w.boersma@mca.nl
Study Locations
-
-
Noord-Holland
-
Alkmaar, Noord-Holland, Netherlands, 1815JD
- Medical Center Alkmaar
-
Contact:
- Wim G Boersma, MD
- Phone Number: 0031725482750
- Email: w.boersma@mca.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Placebo tablets 100mg
|
Experimental: 1
Doxycycline 100mg daily
|
Doxycycline tablets, 100mg daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
myeloperoxidase in induced sputum
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.
Time Frame: 3 weeks
|
3 weeks
|
Lung function (FEV1)
Time Frame: 3 weeks
|
3 weeks
|
Symptom scores
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M07-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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