Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

Medical Center Alkmaar30 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease Inflammation Pulmonary Emphysema

Interventions

DoxycyclineDRUG

Doxycycline tablets, 100mg daily

PlaceboDRUG

Placebo tablets 100mg

Eligibility

Sex: ALLMin age: 41 Years

Medical Language ↔ Plain English

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 (1)

Medical Center Alkmaar

Alkmaar, North Holland, Netherlands

Outcomes

Primary Outcomes

myeloperoxidase in induced sputum

Time frame: 3 weeks

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

Central Contacts

Wim G Boersma, MD

CONTACT

0031725482750 w.boersma@mca.nl

Data from ClinicalTrials.gov

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