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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Nestor Soler Porcar, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier:
NCT01091493
First received: March 19, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Moxifloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy/Safety in treatment on re-hospitalizations at six months. [ Time Frame: Six monts ] [ Designated as safety issue: Yes ]
  • In-hospital stay (days) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: One and Six months ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire [ Time Frame: Hospitalization day 1 and six months ] [ Designated as safety issue: No ]
    This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)


Estimated Enrollment: 224
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Non-Antibiotic
Active Comparator: Antibiotic Drug: Moxifloxacin
Moxifloxacin 400 mg administered once a day for 5 days
Other Name: Actira

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091493

Contacts
Contact: Nestor Soler, MD, PhD +34 932.275.400 ext 2280 nsoler@clinic.ub.es
Contact: Arturo Huerta, MD +34 932.275.400 ext 5549 ahuerta@clinic.ub.es

Locations
Spain
Hospital Miquel Servet Active, not recruiting
Zaragoza, Aragon, Spain, 50009
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Arturo Huerta, MD    +34 679.788.559    ahuerta@clinic.ub.es   
Sub-Investigator: Arturo H Huerta, MD         
Principal Investigator: Nestor Soler, MD, PhD         
Fundació La Fe- Hospital La Fe Recruiting
Valencia, Comunitat Valenciana, Spain, 46009
Contact: Rosario Menendez, MD, PhD       rmenend@separ.es   
Principal Investigator: Rosario Menendez, MD, PhD         
Hospital Clínica Platón Active, not recruiting
Barcelona, Spain, 08006
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Instituto de Salud Carlos III
Investigators
Principal Investigator: Nestor Soler, MD,PhD Hospital Clinic de Barcelona
  More Information

Publications:
Responsible Party: Nestor Soler Porcar, Especialista Senior, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT01091493     History of Changes
Other Study ID Numbers: AEPOC-ATB
Study First Received: March 19, 2010
Last Updated: July 22, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Moxifloxacin
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014