Utility of Antibiotic Treatment in Non-purulent Exacerbations of Chronic Obstructive Pulmonary Disease: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01091493
• Date of registration: 19/03/2010
• Primary sponsor: Fundacion Clinic per a la Recerca Biomédica
• Public title: Utility of Antibiotic Treatment in Non-purulent Exacerbations of Chronic Obstructive Pulmonary Disease: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy AEPOC-ATB
• Scientific title: Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy
• Date of first enrolment: July 2010
• Target sample size: 224
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01091493
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Nestor Soler, MD, PhD

• Name: Nestor Soler, MD,PhD
• Affiliation: Hospital Clinic de Barcelona

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Drug: Moxifloxacin

Primary Outcome(s)

Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD [Time Frame: Six months]

Secondary Outcome(s)

All cause mortality [Time Frame: One and Six months]

Efficacy/Safety in treatment on re-hospitalizations at six months. [Time Frame: Six monts]

In-hospital stay (days) [Time Frame: Six months]

Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire [Time Frame: Hospitalization day 1 and six months]

Secondary ID(s)

AEPOC-ATB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Salud Carlos III