COPD Exacerbation
Conditions
Keywords
COPD exacerbation, fluoroquinolones,
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.
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.
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.
Sponsors
Fadoi Foundation, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Successful Treatment to Day 7 of Treatment | 7 days |
Other
| Measure | Time frame |
|---|---|
| Rehospitalization for COPD Exacerbation During the Follow-up | one year |
| Number of Episodes of Exacerbations | one year |
| Additional Cycles of Antibiotic | one year |
| Survival | one year |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 128 |
| 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
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. | 130 |
| Total | 258 |
Baseline characteristics
| Characteristic | Prulifloxacin 1 Tablet 600 mg Once a Day | Total | Levofloxacin 1 Tablet 500 mg Once a Day |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 121 Participants | 240 Participants | 119 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 9 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Italy | 130 participants | 258 participants | 128 participants |
| Sex: Female, Male Female | 39 Participants | 76 Participants | 37 Participants |
| Sex: Female, Male Male | 91 Participants | 182 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 128 | 5 / 130 |
| other Total, other adverse events | 1 / 128 | 5 / 130 |
| serious Total, serious adverse events | 2 / 128 | 1 / 130 |
Outcome results
Primary
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
Population: The analyses concerning the primary study end-point were carried out both on the intention-to-treat and per-protocol populations, more than 90% of patients had a therapeutic success at the end of treatment cycle in both study groups. Here is reported the ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Levofloxacin 1 Tablet 500 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). | 119 Participants |
| Prulifloxacin 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). | 126 Participants |
Secondary
Percentage of Successful Treatment to Day 7 of Treatment
Time frame: 7 days
Other Pre-specified
Additional Cycles of Antibiotic
Time frame: one year
Other Pre-specified
Number of Episodes of Exacerbations
Time frame: one year
Other Pre-specified
Rehospitalization for COPD Exacerbation During the Follow-up
Time frame: one year
Other Pre-specified
Survival
Time frame: one year