Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy

Study Overview
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Brief Summary
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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.

Official Title
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Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-Antibiotic<br>Patients will not receive antibiotics, although the study is double-blind. | |
| Active Comparator: Antibiotic<br>Patients will receive in a masked way, moxifloxacin. | Drug: Moxifloxacin<br>* Moxifloxacin 400 mg administered once a day for 5 days<br>* Other names: Actira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ) | Hospitalization day 1 and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD