Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
COPD is one of the most important causes of morbidity and mortality and supposes a sanitary problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation of COPD (AECOPD) per year, being these the principal causes of of hospitalizations, respiratory problems and medical visits. After an episode of AECOPD, the majority of patients develop a transitory (or permanent) worsening in their quality of life and 50% of them will require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an evidence of viral infection could be documented. Even though the antibiotic treatment might not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD results in a very expensive disease and raises the rate of resistance of bacteria. The available literature have shown that there's a relation between exacerbations and infections, based on sputum samples. In summary, is well known that at least a 50% of the episodes of AECOPD might be associated with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide and generalized in hospitalized patients. Clinical trials have shown correlation between AECOPD with sputum purulence (which correlates with presence of bacteria), however they've not included NON-purulent AECOPD, even though they're a significative group of patients hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of antibiotic treatment in this group of patients in a well designed trial.
Interventions
DRUGMoxifloxacin
Moxifloxacin 400 mg administered once a day for 5 days
Sponsors
Instituto de Salud Carlos III
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* COPD diagnosis according to GOLD guidelines * Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease * Failure of outpatient treatment * Increasing of dyspnea in the last days * Comorbidity that causes detriment of respiratory function
Exclusion criteria
* Life expectancy of less than 6 months * Mechanical Ventilation * Cardiovascular condition that causes exacerbation * Immunosuppression * Pulmonary infiltrates that suggest pneumonia * Antibiotic treatment in the last month * Pregnancy * ECG with a large QT segment * Hypokalemia * Hepatic failure or renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD | Six months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy/Safety in treatment on re-hospitalizations at six months. | Six monts | — |
| In-hospital stay (days) | Six months | — |
| All cause mortality | One and Six months | — |
| Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire | Hospitalization day 1 and six months | This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ) |
Countries
Spain
Outcome results
None listed