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

Chronic Obstructive Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00857038
• Other study ID #: M07-046
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 5, 2009
• Last updated: March 5, 2009
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: March 2009
• Source: Medical Center Alkmaar
• Contact: Wim G Boersma, MD
• Phone: 0031725482750
• Email: w.boersma[@]mca.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Inflammation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Drug:
• Doxycycline
Doxycycline tablets, 100mg daily
• Placebo
Placebo tablets 100mg

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar	Noord-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Medical Center Alkmaar	Leiden University Medical Center, VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myeloperoxidase in induced sputum		3 weeks	No
Secondary	MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.		3 weeks	No
Secondary	Lung function (FEV1)		3 weeks	No
Secondary	Symptom scores		3 weeks	No