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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091493
Recruitment Status : Active, not recruiting
First Posted : March 24, 2010
Last Update Posted : April 13, 2018
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Nestor Soler Porcar, MD, PhD, Fundacion Clinic per a la Recerca Biomédica

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Moxifloxacin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy
Study Start Date : July 2010
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Non-Antibiotic
Patients will not receive antibiotics, although the study is double-blind.
Active Comparator: Antibiotic
Patients will receive in a masked way, moxifloxacin.
Drug: Moxifloxacin
Moxifloxacin 400 mg administered once a day for 5 days
Other Name: Actira

Primary Outcome Measures :
  1. Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Efficacy/Safety in treatment on re-hospitalizations at six months. [ Time Frame: Six monts ]
  2. In-hospital stay (days) [ Time Frame: Six months ]
  3. All cause mortality [ Time Frame: One and Six months ]
  4. Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire [ Time Frame: Hospitalization day 1 and six months ]
    This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091493

Hospital Miquel Servet
Zaragoza, Aragon, Spain, 50009
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Fundació La Fe- Hospital La Fe
Valencia, Comunitat Valenciana, Spain, 46009
Hospital Clínica Platón
Barcelona, Spain, 08006
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Instituto de Salud Carlos III
Principal Investigator: Nestor Soler, MD,PhD Hospital Clinic of Barcelona

Responsible Party: Nestor Soler Porcar, MD, PhD, Especialista Senior, Fundacion Clinic per a la Recerca Biomédica Identifier: NCT01091493     History of Changes
Other Study ID Numbers: AEPOC-ATB
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Keywords provided by Nestor Soler Porcar, MD, PhD, Fundacion Clinic per a la Recerca Biomédica:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs