Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28324

Enrollment

470

Registered

2010-09-09

Start date

2010-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, antibiotics, exacerbation, doxycyclin COPD, antibiotica, exacerbatie, doxycycline

Interventions

A cohort of 1000 participants will be collected. In case of an exacerbation, patients will be randomized between doxycyclin and placebo. Not eligible for randomization are patients who should be treat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 45 years and older; 2. COPD GOLD 1, 2 or 3; 3. At least 1 documented or self-reported exacerbation during the past 3 years; 4. Last exacerbation at least 4 weeks prior to inclusion, and symptoms returned to patient’s baseline level; 5. A smoking history of at least 10 pack years.

Exclusion criteria

Exclusion criteria: 1. Poor cognitive functioning; 2. Poor mastering of the Dutch language; 3. Allergy for doxycyclin; 4. Pregnancy; 5. A life expectancy less than 1 month.

Design outcomes

Secondary

Measure	Time frame
1. Mortality during follow up; 2. Number of exacerbations during follow up; 3. Treatment failure rate at test of cure (day 21) and late follow-up (day 90); 4. Cultured microorganisms at subsequent exacerbation, and, in subgroup, during 6 months after exacerbation; 5. Health related quality of life; 6. Decline of lung volumes; 7. Total antibiotic use; 8. Costs.	—

Primary

Measure	Time frame
Time to next exacerbation.	—

Contacts

Public ContactP. Velzen, van

P.O. Box 22660

P.vanvelzen@amc.nl+31 (0)20 5664359

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)