Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsor:	Medical Center Alkmaar
Collaborators:	Leiden University Medical Center VU University of Amsterdam
Information provided by:	Medical Center Alkmaar
ClinicalTrials.gov Identifier:	NCT00857038

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease Inflammation Pulmonary Emphysema	Drug: Doxycycline Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Emphysema

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:

myeloperoxidase in induced sputum [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Lung function (FEV1) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Symptom scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Doxycycline 100mg daily	Drug: Doxycycline Doxycycline tablets, 100mg daily
2: Placebo Comparator Placebo	Drug: Placebo Placebo tablets 100mg

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

Ages Eligible for Study:	41 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857038

Contacts

Contact: Wim G Boersma, MD

0031725482750

w.boersma@mca.nl

Locations

Netherlands, Noord-Holland
Medical Center Alkmaar
Alkmaar, Noord-Holland, Netherlands, 1815JD

Sponsors and Collaborators

Medical Center Alkmaar

Leiden University Medical Center

VU University of Amsterdam

More Information

No publications provided

Responsible Party:	Medical Center Alkmaar ( Boersma, MD, PhD )
Study ID Numbers:	M07-046
Study First Received:	March 5, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857038 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Medical Center Alkmaar:

COPD
Inflammation
Neutrophilic
Myeloperoxidase
Doxycycline

Additional relevant MeSH terms:

Emphysema
Anti-Infective Agents
Antiprotozoal Agents
Respiration Disorders
Pharmacologic Actions
Inflammation
Pulmonary Emphysema
Antimalarials
Anti-Bacterial Agents

Antiparasitic Agents
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Doxycycline
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010