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

Chronic obstuctive pulmonary disease (COPD) is a very

prevalent, chronic disease. For the majority of COPD

outpatients, it is at the present not clear whether during an

exacerbation antibiotics should be added to treatment with

corticosteroids. On the short term, antibiotic treatment has

limited added value. However, retrospective data manifest a

prolonged time to the next exacerbation. The major drawback of

treating all exacerbations with antibiotic, will be the

significant increase in overall antibiotic consumption, which will

fuel the increasing rates of resistance among respiratory

pathogens. Therefore, benefits of antibiotic treatment have to

be confirmed in a prospective study.

We postulate that antiobiotics added to corticosteroids in the treatment of exacerbations of COPD, will prolong time to next exacerbation.

1. At inclusion in cohort: History, clinical evaluation, sputum culture;

2. At inclusion in randomized clinical trial: History, clinical evaluation, sputum culture;

3. Follow up at week 1, 2, 3 ,4, 12, 24, 36, 48, 60, 72, 84, 96 after inclusion in randomized clinical trial.

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 treated with antibiotics according to current guidelines, patients who require hospitalization, patients who currently use antibiotics and patients who used antibiotics for a respiratory tract infection in the last 3 weeks.
Target number of participants in the RCT is 470 (needed to collect 251 second exacerbations).