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

March 5, 2009
March 5, 2009
April 2009
August 2009   (final data collection date for primary outcome measure)
myeloperoxidase in induced sputum [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • Inflammation
  • Pulmonary Emphysema
  • Drug: Doxycycline
    Doxycycline tablets, 100mg daily
  • Drug: Placebo
    Placebo tablets 100mg
  • Experimental: 1
    Doxycycline 100mg daily
    Intervention: Drug: Doxycycline
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
January 2010
August 2009   (final data collection date for primary outcome measure)

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.
Both
41 Years and older
No
Contact: Wim G Boersma, MD 0031725482750 w.boersma@mca.nl
Netherlands
 
NCT00857038
M07-046
No
Boersma, MD, PhD, Medical Center Alkmaar
Medical Center Alkmaar
  • Leiden University Medical Center
  • VU University of Amsterdam
Not Provided
Medical Center Alkmaar
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP