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

Primary Purpose

COPD Exacerbation

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Levofloxacin 1 tablet 500 mg once a day
Prulifloxacin 1 tablet 600 mg once a day
Sponsored by
Fadoi Foundation, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring COPD exacerbation, fluoroquinolones,

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospita "San Francesco Caracciolo"
  • Hospital of Alghero
  • Hospital "Cardinal Massaia"
  • Hospital "Fatebenefratelli"
  • Hospital of Bordighera
  • Hospital "San Giovanni di Dio"
  • Hospital "Pugliese-Ciaccio"
  • Hospital "L.Parodi Delfino"
  • Hospita "San Giovanni di Dio"
  • Hospital "E.Profili" of Fabriano
  • Hospital "F. Veneziale"
  • Hospital Civile Legnano
  • Hospital of Ortona
  • Hospital Fatebenefratelli "Buccheri La Ferla"
  • Hospital "Sant'Anna"
  • Hospital " Santa Maria Nuova"
  • Hospital "Policlinico Universitario Campus Biomedico"
  • Hospital "Casa Sollievo della Sofferenza"
  • Hospital of Scandiano
  • Hospital "Paolo Dettori"
  • Hospital "Santa Maria" of Terni
  • Hospital "San Giovanni Bosco"
  • Hospital "Jazzolino"
  • Hospital "San Bortolo"
  • Hospital "Santa Maria Maddalena"

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Levofloxacin 1 tablet 500 mg once a day

Prulifloxacin 1 tablet 600 mg once a day

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Percentage of successful treatment to day 7 of treatment

Full Information

First Posted
October 12, 2012
Last Updated
January 11, 2017
Sponsor
Fadoi Foundation, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01710488
Brief Title
Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD
Acronym
FLOR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fadoi Foundation, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
COPD exacerbation, fluoroquinolones,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin 1 tablet 500 mg once a day
Arm Type
Active Comparator
Arm Description
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
Arm Title
Prulifloxacin 1 tablet 600 mg once a day
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 1 tablet 500 mg once a day
Other Intervention Name(s)
LEVOXACIN 500 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prulifloxacin 1 tablet 600 mg once a day
Other Intervention Name(s)
UNIDROX 600 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Percentage of successful treatment to day 7 of treatment
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
rehospitalization for COPD exacerbation during the follow-up
Time Frame
one year
Title
Number of episodes of Exacerbations
Time Frame
one year
Title
Additional cycles of antibiotic
Time Frame
one year
Title
survival
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gualberto GG Gussoni, MD, PhD
Organizational Affiliation
Dept. Clinical Research "Study Centre" - FadoiFoundation
Official's Role
Study Director
Facility Information:
Facility Name
Hospita "San Francesco Caracciolo"
City
Agnone
ZIP/Postal Code
86081
Country
Italy
Facility Name
Hospital of Alghero
City
Alghero
ZIP/Postal Code
07041
Country
Italy
Facility Name
Hospital "Cardinal Massaia"
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Hospital "Fatebenefratelli"
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Hospital of Bordighera
City
Bordighera
ZIP/Postal Code
18012
Country
Italy
Facility Name
Hospital "San Giovanni di Dio"
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Hospital "Pugliese-Ciaccio"
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Hospital "L.Parodi Delfino"
City
Colleferro
ZIP/Postal Code
00034
Country
Italy
Facility Name
Hospita "San Giovanni di Dio"
City
Crotone
ZIP/Postal Code
88900
Country
Italy
Facility Name
Hospital "E.Profili" of Fabriano
City
Fabriano
ZIP/Postal Code
60044
Country
Italy
Facility Name
Hospital "F. Veneziale"
City
Isernia
ZIP/Postal Code
86170
Country
Italy
Facility Name
Hospital Civile Legnano
City
Legnano
ZIP/Postal Code
20025
Country
Italy
Facility Name
Hospital of Ortona
City
Ortona
ZIP/Postal Code
66100
Country
Italy
Facility Name
Hospital Fatebenefratelli "Buccheri La Ferla"
City
Palermo
ZIP/Postal Code
90123
Country
Italy
Facility Name
Hospital "Sant'Anna"
City
Reggio Emilia
ZIP/Postal Code
42035
Country
Italy
Facility Name
Hospital " Santa Maria Nuova"
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Hospital "Policlinico Universitario Campus Biomedico"
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Hospital "Casa Sollievo della Sofferenza"
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Hospital of Scandiano
City
Scandiano
ZIP/Postal Code
42019
Country
Italy
Facility Name
Hospital "Paolo Dettori"
City
Tempio Pausania
ZIP/Postal Code
0729
Country
Italy
Facility Name
Hospital "Santa Maria" of Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Hospital "San Giovanni Bosco"
City
Torino
ZIP/Postal Code
10100
Country
Italy
Facility Name
Hospital "Jazzolino"
City
Vibo Valentia
ZIP/Postal Code
89900
Country
Italy
Facility Name
Hospital "San Bortolo"
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Hospital "Santa Maria Maddalena"
City
Volterra
ZIP/Postal Code
56048
Country
Italy

12. IPD Sharing Statement

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

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