COPD ExacerbationPhase 4FLORNCT01710488
Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD
A Phase 4 study testing Levofloxacin 1 tablet 500 mg once a day and Prulifloxacin 1 tablet 600 mg once a day in people with COPD Exacerbation, run by Fadoi Foundation, Italy at 25 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Levofloxacin 1 tablet 500 mg once a day and Prulifloxacin 1 tablet 600 mg once a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 25 sitesItaly
- Study dates
- May 2009to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Show all 9Show fewer
- FEV1 <80% and ≥ 30% and ratio FEV 1 / FVC <70%
- chest x-ray negative for inflammatory infiltrates
- informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites
Hospita "San Francesco Caracciolo"
Agnone, 86081
Hospital of Alghero
Alghero, 07041
Hospital "Cardinal Massaia"
Asti, 14100
Hospital "Fatebenefratelli"
Benevento, 82100
Hospital of Bordighera
Bordighera, 18012
Hospital "San Giovanni di Dio"
Cagliari, 09124
Hospital "Pugliese-Ciaccio"
Catanzaro, 88100
Hospital "L.Parodi Delfino"
Colleferro, 00034
Hospita "San Giovanni di Dio"
Crotone, 88900
Hospital "E.Profili" of Fabriano
Fabriano, 60044
Hospital "F. Veneziale"
Isernia, 86170
Hospital Civile Legnano
Legnano, 20025
Hospital of Ortona
Ortona, 66100
Hospital Fatebenefratelli "Buccheri La Ferla"
Palermo, 90123
Hospital "Sant'Anna"
Reggio Emilia, 42035
Hospital " Santa Maria Nuova"
Reggio Emilia, 42123
Hospital "Policlinico Universitario Campus Biomedico"
Rome, 00128
Hospital "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, 71013
Hospital of Scandiano
Scandiano, 42019
Hospital "Paolo Dettori"
Tempio Pausania, 0729
Hospital "Santa Maria" of Terni
Terni, 05100
Hospital "San Giovanni Bosco"
Torino, 10100
Hospital "Jazzolino"
Vibo Valentia, 89900
Hospital "San Bortolo"
Vicenza, 36100
Hospital "Santa Maria Maddalena"
Volterra, 56048
About this study
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
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.
- Conditions
- COPD Exacerbation
- Being tested
- Levofloxacin 1 tablet 500 mg once a day, Prulifloxacin 1 tablet 600 mg once a day
- Keywords
- COPD exacerbation, fluoroquinolones,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin 1 tablet 500 mg once a dayDrug
Also called LEVOXACIN 500 mg
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.
Prulifloxacin 1 tablet 600 mg once a dayDrug
Also called UNIDROX 600 mg
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.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin 1 tablet 500 mg once a day | Active comparator | 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 Receives: Drug: Levofloxacin 1 tablet 500 mg once a day |
| Prulifloxacin 1 tablet 600 mg once a day | Experimental | 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 Receives: Drug: Prulifloxacin 1 tablet 600 mg once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 days
Secondary outcomes (1)
Percentage of Successful Treatment to Day 7 of Treatment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startMay 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gualberto GG Gussoni, MD, PhD, Study director, Dept. Clinical Research "Study Centre" - FadoiFoundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710488
- Sponsor's protocol ID
- EudraCT N. 2008-003842-27
- Acronym
- FLOR
- Status last verified
- Oct 2012
- First submitted
- 12 Oct 2012
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01710488
- Acronym / sponsor ID
- FLOR / EudraCT N. 2008-003842-27
- Conditions
- COPD Exacerbation
- Keywords
- COPD exacerbation, fluoroquinolones,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Posted 11 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin 1 tablet 500 mg once a day | Active comparator | Drug: Levofloxacin 1 tablet 500 mg once a dayLevofloxacin 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 | Experimental | Drug: Prulifloxacin 1 tablet 600 mg once a dayPrulifloxacin 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin 1 tablet 500 mg once a dayAlso: LEVOXACIN 500 mgWill 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. | Drug | Levofloxacin 1 tablet 500 mg once a day |
| Prulifloxacin 1 tablet 600 mg once a dayAlso: UNIDROX 600 mgWill 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. | Drug | Prulifloxacin 1 tablet 600 mg once a day |
Primary outcome
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).
Time frame: 10 days
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).
1 secondary outcome
Percentage of Successful Treatment to Day 7 of Treatment
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gualberto GG Gussoni, MD, PhD study director
Dept. Clinical Research "Study Centre" - FadoiFoundation
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levofloxacin 1 tablet 500 mg once a day and Prulifloxacin 1 tablet 600 mg once a day in people with COPD Exacerbation, run by Fadoi Foundation, Italy at 25 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.