Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
Information source: Medical Center Alkmaar
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease; Inflammation; Pulmonary Emphysema
Intervention: Doxycycline (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Medical Center Alkmaar Overall contact:
Wim G Boersma, MD, Phone: 0031725482750, Email: w.boersma@mca.nl
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. 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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: myeloperoxidase in induced sputum
Secondary outcome: MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.Lung function (FEV1) Symptom scores
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.
Eligibility
Minimum age: 41 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Wim G Boersma, MD, Phone: 0031725482750, Email: w.boersma@mca.nl
Medical Center Alkmaar, Alkmaar, Noord-Holland 1815JD, Netherlands
Additional Information
Starting date: April 2009
Ending date: January 2010
Last updated: March 5, 2009
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