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

Phase 4

• Conditions: Chronic Obstructive Pulmonary Disease; Inflammation; Pulmonary Emphysema
• Interventions: Drug: Doxycycline; Drug: Placebo

• Registration Number: NCT00857038
• Lead Sponsor: Medical Center Alkmaar

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.

Study Timeline

• Status Verified: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Last Update Submitted: 2009-03-05
• Study First Posted: 2009-03-06
• Last Update Posted: 2009-03-06
• Study Start: 2009-04
• Primary Completion: 2009-08
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Doxycycline	Doxycycline 100mg daily
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
myeloperoxidase in induced sputum	3 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Center Alkmaar; 🇳🇱 Alkmaar, Noord-Holland, Netherlands