Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD (FLOR)

A Randomized, Controlled, Single-blind, Parallel-group Comparison Between Levofloxacin and Prulifloxacin, in Patients With Acute Exacerbation of COPD Unresponsive to Other Antibiotics and Admitted to the Internal Medicine

The primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation
• Intervention / Treatment: Drug: Levofloxacin 1 tablet 500 mg once a day; Drug: Prulifloxacin 1 tablet 600 mg once a day

Detailed Description

The aim of this study was to examine the effects of the use of fluoroquinolones a class of antibiotics introduced relatively recently, in a particular population of patients with acute exacerbation of COPD, previously treated unsuccessfully with other antibiotics, and hospitalized in Internal Medicine. These patients reflect the reality of patients admitted to Internal Medicine, they are characterized by a high frequency of advanced age, polypathology, with multiple treatments.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Agnone, Italy, 86081
    • Hospita "San Francesco Caracciolo"
  • Alghero, Italy, 07041
    • Hospital of Alghero
  • Asti, Italy, 14100
    • Hospital "Cardinal Massaia"
  • Benevento, Italy, 82100
    • Hospital "Fatebenefratelli"
  • Bordighera, Italy, 18012
    • Hospital of Bordighera
  • Cagliari, Italy, 09124
    • Hospital "San Giovanni di Dio"
  • Catanzaro, Italy, 88100
    • Hospital "Pugliese-Ciaccio"
  • Colleferro, Italy, 00034
    • Hospital "L.Parodi Delfino"
  • Crotone, Italy, 88900
    • Hospita "San Giovanni di Dio"
  • Fabriano, Italy, 60044
    • Hospital "E.Profili" of Fabriano
  • Isernia, Italy, 86170
    • Hospital "F. Veneziale"
  • Legnano, Italy, 20025
    • Hospital Civile Legnano
  • Ortona, Italy, 66100
    • Hospital of Ortona
  • Palermo, Italy, 90123
    • Hospital Fatebenefratelli "Buccheri La Ferla"
  • Reggio Emilia, Italy, 42035
    • Hospital "Sant'Anna"
  • Reggio Emilia, Italy, 42123
    • Hospital " Santa Maria Nuova"
  • Rome, Italy, 00128
    • Hospital "Policlinico Universitario Campus Biomedico"
  • San Giovanni Rotondo, Italy, 71013
    • Hospital "Casa Sollievo della Sofferenza"
  • Scandiano, Italy, 42019
    • Hospital of Scandiano
  • Tempio Pausania, Italy, 0729
    • Hospital "Paolo Dettori"
  • Terni, Italy, 05100
    • Hospital "Santa Maria" of Terni
  • Torino, Italy, 10100
    • Hospital "San Giovanni Bosco"
  • Vibo Valentia, Italy, 89900
    • Hospital "Jazzolino"
  • Vicenza, Italy, 36100
    • Hospital "San Bortolo"
  • Volterra, Italy, 56048
    • Hospital "Santa Maria Maddalena"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp Med 2005), plus at least two of the following signs-symptoms
• Increased cough
• Increased dyspnea
• Increase in sputum volume appeared at least 3 days
• previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital
• ≥ 60 years
• FEV1 <80% and ≥ 30% and ratio FEV 1 / FVC <70%
• chest x-ray negative for inflammatory infiltrates
• informed consent

Exclusion Criteria:

• asthma
• pulmonary neoplasms
• a history of allergy or hypersensitivity to quinolones
• impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system
• a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months)
• history of tendinopathy
• note or severe renal impairment creatinine> than twice the upper limit of the normal range or hepatic impairment (AST and / or ALT> twice the upper limit of the normal range)
• patients with sepsis, tuberculosis or other infections in other organs or systems
• cystic fibrosis
• patients with inherited tolerance to intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase
• pregnant or breastfeeding
• drug or alcohol addiction
• experimental concomitant treatment with other drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levofloxacin 1 tablet 500 mg once a day; Levofloxacin 1 tablet 500 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients	Drug: Levofloxacin 1 tablet 500 mg once a day; Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients: Levofloxacin 500 mg (1 tablet) once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.; Other Names: LEVOXACIN 500 mg
Experimental: Prulifloxacin 1 tablet 600 mg once a day; Prulifloxacin 1 tablet 600 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients	Drug: Prulifloxacin 1 tablet 600 mg once a day; Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients: Prulifloxacin 1 tablet 600 mg once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.; Other Names: UNIDROX 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin).	The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of successful treatment to day 7 of treatment	7 days

Other Outcome Measures

Outcome Measure	Time Frame
survival	one year
rehospitalization for COPD exacerbation during the follow-up	one year
Number of episodes of Exacerbations	one year
Additional cycles of antibiotic	one year

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy
• Investigators: Study Director: Gualberto GG Gussoni, MD, PhD, Dept. Clinical Research "Study Centre" - FadoiFoundation

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: COPD exacerbation; fluoroquinolones,
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin; Prulifloxacin
• Other Study ID Numbers: EudraCT N. 2008-003842-27