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Status unknownNCT00857038Updated Mar 6, 2009

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

A Phase 4 interventional study of Doxycycline and Placebo in Chronic Obstructive Pulmonary Disease, Inflammation and Pulmonary Emphysema, sponsored by Medical Center Alkmaar. Status unknown at 1 site in Netherlands. Open to participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2009-03-06.

Sponsored by Medical Center Alkmaar · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
41 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Inflammation
  • Pulmonary Emphysema

Keywords

  • COPD
  • Inflammation
  • Neutrophilic
  • Myeloperoxidase
  • Doxycycline
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Medical Center Alkmaar is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
41 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    Doxycycline 100mg daily

    Drug: Doxycycline

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugDoxycycline

    Doxycycline tablets, 100mg daily

  • DrugPlacebo

    Placebo tablets 100mg

06

What researchers measure

Primary outcomes

  1. myeloperoxidase in induced sputum

    Time frame: 3 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • Medical Center Alkmaar
    Alkmaar, Noord-Holland 1815JD, Netherlands
08

References and documents

Publications

  • Prins HJ, Daniels JM, Lindeman JH, Lutter R, Boersma WG. Effects of doxycycline on local and systemic inflammation in stable COPD patients, a randomized clinical trial. Respir Med. 2016 Jan;110:46-52. doi: 10.1016/j.rmed.2015.10.009. Epub 2015 Oct 30. PubMed 26616678 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00857038
Lead sponsor
Medical Center Alkmaar
Collaborators
Leiden University Medical Center, University of Amsterdam
First posted
Mar 6, 2009
Start date
Apr 2009
Primary completion
Aug 2009 (estimated)
Completion
Jan 2010 (estimated)
Last update
Mar 6, 2009

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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