To assess the effect of low dose doxycycline on markers of neutrophilic inflammation and proteolytic activity stable GOLD III COPD patients.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in sputum IL-6 levels
Secondary outcome
Change in FEV1
Change in markers of neutrophil activation/activity (IL-8, MMP-8, MMP-9 and
MPO), T cell activation (granzyme A and perforin) and monocyte activation
(TNF-α, IL-1, cathepsin K
Background summary
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.
Study objective
To assess the effect of low dose doxycycline on markers of neutrophilic
inflammation and proteolytic activity stable GOLD III COPD patients.
Study design
Placebo versus doxycycline in a cross-over design
Intervention
Doxycycline vs placebo
Study burden and risks
None, except voor mild side-effects from doxycycline, which will be negligible
since the drug is administered in a subtherapeutical dose.
Wilhelminalaan 12
1815JD
NL
Wilhelminalaan 12
1815JD
NL
Listed location countries
Age
Inclusion criteria
• GOLD II COPD (FEV1/FVC < 70%; 50% < FEV1 < 80% 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.
• Allergy for tetracyclines or a history of substantial side-effects.
• Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).
• Signs and/or symptoms consistent with an acute exacerbation of COPD (AECOPD), such as increase in dyspnea, increase in sputum volume or change of sputum color from mucoid to purulent.
• 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004262-41-NL |
| CCMO | NL19032.094.08 |