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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857038

Enrollment

Registered

2009-03-06

Start date

2009-04-30

Completion date

2010-01-31

Last updated

2009-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Inflammation, Pulmonary Emphysema

Keywords

COPD, Inflammation, Neutrophilic, Myeloperoxidase, Doxycycline

Brief 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.

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.

Interventions

DRUGDoxycycline

Doxycycline tablets, 100mg daily

DRUGPlacebo

Placebo tablets 100mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

41 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
myeloperoxidase in induced sputum	3 weeks

Secondary

Measure	Time frame
Symptom scores	3 weeks
MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.	3 weeks
Lung function (FEV1)	3 weeks

Countries

Netherlands

Contacts

Primary ContactWim G Boersma, MD

w.boersma@mca.nl0031725482750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026