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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Medical Center Alkmaar.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Leiden University Medical Center
VU University of Amsterdam
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00857038
First received: March 5, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


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
Experimental: 1
Doxycycline 100mg daily
Drug: Doxycycline
Doxycycline tablets, 100mg daily
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Wim G Boersma, MD 0031725482750 w.boersma@mca.nl

Locations
Netherlands
Medical Center Alkmaar Not yet recruiting
Alkmaar, Noord-Holland, Netherlands, 1815JD
Contact: Wim G Boersma, MD    0031725482750    w.boersma@mca.nl   
Sponsors and Collaborators
Medical Center Alkmaar
Leiden University Medical Center
VU University of Amsterdam
  More Information

No publications provided

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

Keywords provided by Medical Center Alkmaar:
COPD
Inflammation
Neutrophilic
Myeloperoxidase
Doxycycline

Additional relevant MeSH terms:
Lung Diseases
Inflammation
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Emphysema
Respiratory Tract Diseases
Pathologic Processes
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on October 16, 2014