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CompletedNCT01710488FLORUpdated Feb 11, 2025Results posted

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

A Phase 4 interventional study of Levofloxacin 1 tablet 500 mg once a day and Prulifloxacin 1 tablet 600 mg once a day in COPD Exacerbation, sponsored by Fadoi Foundation, Italy. Completed at 25 sites in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Fadoi Foundation, Italy · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
258
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • COPD Exacerbation

Keywords

  • COPD exacerbation
  • fluoroquinolones,
03

In context

Lead sponsor

Fadoi Foundation, Italy is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
258 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugLevofloxacin 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.

    Also known as: LEVOXACIN 500 mg

  • DrugPrulifloxacin 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.

    Also known as: UNIDROX 600 mg

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What researchers measure

Primary outcomes

  1. 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). The primary study end-point was the percentage of patients with "therapeutic success" (disappearance of all signs/symptoms of disease or reduction of at least 3 points of the total score of symptomatology from baseline) at the conclusion of the cycle of antibiotic therapy (day 10), in the two study groups (levofloxacin and prulifloxacin).

    Time frame: 10 days

Secondary outcomes

  1. Percentage of Successful Treatment to Day 7 of Treatment

    Time frame: 7 days

Other outcomes

  1. Rehospitalization for COPD Exacerbation During the Follow-up

    Time frame: one year

  2. Number of Episodes of Exacerbations

    Time frame: one year

  3. Additional Cycles of Antibiotic

    Time frame: one year

  4. Survival

    Time frame: one year

07

Results

Posted Feb 11, 2025

Participant flow

Participant flow — Overall Study
MilestoneLevofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a Day
Started128130
Completed9296
Not completed3634

Outcome measures

PrimaryThe 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). The primary study end-point was the percentage of patients with "therapeutic success" (disappearance of all signs/symptoms of disease or reduction of at least 3 points of the total score of symptomatology from baseline) at the conclusion of the cycle of antibiotic therapy (day 10), in the two study groups (levofloxacin and prulifloxacin).

Time frame:
10 days
Reported as:
Count of participants · Participants
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).
ParticipantsLevofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a Day
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).119126
SecondaryPercentage of Successful Treatment to Day 7 of Treatment
Time frame:
7 days

Results for this outcome have not been posted.

Other pre-specifiedRehospitalization for COPD Exacerbation During the Follow-up
Time frame:
one year

Results for this outcome have not been posted.

Other pre-specifiedNumber of Episodes of Exacerbations
Time frame:
one year

Results for this outcome have not been posted.

Other pre-specifiedAdditional Cycles of Antibiotic
Time frame:
one year

Results for this outcome have not been posted.

Other pre-specifiedSurvival
Time frame:
one year

Results for this outcome have not been posted.

Adverse events

Collected over Total time frame for adeverse drug reaction: 10 days or 7 days + 1 month Total time frame for survival: 10 days or 7 days + 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Levofloxacin 1 Tablet 500 mg Once a Day11/128 (8.6%)2/128 (1.6%)1/128 (0.8%)
Prulifloxacin 1 Tablet 600 mg Once a Day5/130 (3.8%)1/130 (0.8%)5/130 (3.8%)
Most frequent serious events
Most frequent serious events
EventLevofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a Day
DiarrheaGastrointestinal disorders2/1280/130
Acute renal failureRenal and urinary disorders0/1281/130
Most frequent other events
Most frequent other events
EventLevofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a Day
DiarrheaGastrointestinal disorders1/1282/130
Musculoskeletal painMusculoskeletal and connective tissue disorders0/1281/130
Psychomotor agitationNervous system disorders0/1281/130
muscular painMusculoskeletal and connective tissue disorders0/1281/130
Epigastric painGastrointestinal disorders0/1281/130
Acute enteritisGastrointestinal disorders0/1281/130

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Levofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a DayTotal
<=18 years000
Between 18 and 65 years9918
>=65 years119121240
Sex: Female, Male
Sex: Female, Male(Participants)Levofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a DayTotal
Female373976
Male9191182
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Levofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a DayTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Levofloxacin 1 Tablet 500 mg Once a DayPrulifloxacin 1 Tablet 600 mg Once a DayTotal
Italy128130258
08

Study locations

25 sites
  • Hospita "San Francesco Caracciolo"
    Agnone, 86081, Italy
  • Hospital of Alghero
    Alghero, 07041, Italy
  • Hospital "Cardinal Massaia"
    Asti, 14100, Italy
  • Hospital "Fatebenefratelli"
    Benevento, 82100, Italy
  • Hospital of Bordighera
    Bordighera, 18012, Italy
  • Hospital "San Giovanni di Dio"
    Cagliari, 09124, Italy
  • Hospital "Pugliese-Ciaccio"
    Catanzaro, 88100, Italy
  • Hospital "L.Parodi Delfino"
    Colleferro, 00034, Italy
  • Hospita "San Giovanni di Dio"
    Crotone, 88900, Italy
  • Hospital "E.Profili" of Fabriano
    Fabriano, 60044, Italy
  • Hospital "F. Veneziale"
    Isernia, 86170, Italy
  • Hospital Civile Legnano
    Legnano, 20025, Italy
  • Hospital of Ortona
    Ortona, 66100, Italy
  • Hospital Fatebenefratelli "Buccheri La Ferla"
    Palermo, 90123, Italy
  • Hospital "Sant'Anna"
    Reggio Emilia, 42035, Italy
  • Hospital " Santa Maria Nuova"
    Reggio Emilia, 42123, Italy
  • Hospital "Policlinico Universitario Campus Biomedico"
    Rome, 00128, Italy
  • Hospital "Casa Sollievo della Sofferenza"
    San Giovanni Rotondo, 71013, Italy
  • Hospital of Scandiano
    Scandiano, 42019, Italy
  • Hospital "Paolo Dettori"
    Tempio Pausania, 0729, Italy
  • Hospital "Santa Maria" of Terni
    Terni, 05100, Italy
  • Hospital "San Giovanni Bosco"
    Torino, 10100, Italy
  • Hospital "Jazzolino"
    Vibo Valentia, 89900, Italy
  • Hospital "San Bortolo"
    Vicenza, 36100, Italy
  • Hospital "Santa Maria Maddalena"
    Volterra, 56048, Italy
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01710488
Lead sponsor
Fadoi Foundation, Italy
Responsible party
Sponsor
First posted
Oct 19, 2012
Start date
May 2009
Primary completion
Nov 2013
Completion
Nov 2013
Results posted
Feb 11, 2025
Last update
Feb 11, 2025

Study contacts

Gualberto GG Gussoni, MD, PhD
study director · Dept. Clinical Research "Study Centre" - FadoiFoundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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