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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857038
Recruitment Status : Unknown
Verified March 2009 by Medical Center Alkmaar.
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2009
Last Update Posted : March 6, 2009
Leiden University Medical Center
University of Amsterdam
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Inflammation Pulmonary Emphysema Drug: Doxycycline Drug: Placebo Phase 4

Detailed Description:


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.


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.


Placebo versus doxycycline in randomised design.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : April 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Doxycycline 100mg daily
Drug: Doxycycline
Doxycycline tablets, 100mg daily

Placebo Comparator: 2
Drug: Placebo
Placebo tablets 100mg

Primary Outcome Measures :
  1. myeloperoxidase in induced sputum [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum. [ Time Frame: 3 weeks ]
  2. Lung function (FEV1) [ Time Frame: 3 weeks ]
  3. Symptom scores [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857038

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Contact: Wim G Boersma, MD 0031725482750

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Medical Center Alkmaar Not yet recruiting
Alkmaar, Noord-Holland, Netherlands, 1815JD
Contact: Wim G Boersma, MD    0031725482750   
Sponsors and Collaborators
Medical Center Alkmaar
Leiden University Medical Center
University of Amsterdam

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boersma, MD, PhD, Medical Center Alkmaar Identifier: NCT00857038     History of Changes
Other Study ID Numbers: M07-046
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009
Keywords provided by Medical Center Alkmaar:
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Pathologic Processes
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents