Trial Outcomes & Findings for Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD (NCT NCT01710488)
NCT ID: NCT01710488
Last Updated: 2025-02-11
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
258 participants
Primary outcome timeframe
10 days
Results posted on
2025-02-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
130
|
|
Overall Study
COMPLETED
|
92
|
96
|
|
Overall Study
NOT COMPLETED
|
36
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Levofloxacin 1 Tablet 500 mg Once a Day
n=128 Participants
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.
|
Prulifloxacin 1 Tablet 600 mg Once a Day
n=130 Participants
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.
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=128 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=258 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=128 Participants
|
9 Participants
n=130 Participants
|
18 Participants
n=258 Participants
|
|
Age, Categorical
>=65 years
|
119 Participants
n=128 Participants
|
121 Participants
n=130 Participants
|
240 Participants
n=258 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=128 Participants
|
39 Participants
n=130 Participants
|
76 Participants
n=258 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=128 Participants
|
91 Participants
n=130 Participants
|
182 Participants
n=258 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
128 participants
n=128 Participants
|
130 participants
n=130 Participants
|
258 participants
n=258 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: 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
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).
Outcome measures
| Measure |
Levofloxacin 1 Tablet 500 mg Once a Day
n=128 Participants
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.
|
Prulifloxacin 1 Tablet 600 mg Once a Day
n=130 Participants
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.
|
|---|---|---|
|
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
|
126 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: one yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: one yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: one yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: one yearOutcome measures
Outcome data not reported
Adverse Events
Levofloxacin 1 Tablet 500 mg Once a Day
Serious events: 2 serious events
Other events: 1 other events
Deaths: 11 deaths
Prulifloxacin 1 Tablet 600 mg Once a Day
Serious events: 1 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Levofloxacin 1 Tablet 500 mg Once a Day
n=128 participants at risk
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.
|
Prulifloxacin 1 Tablet 600 mg Once a Day
n=130 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
2/128 • Number of events 2 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
0.00%
0/130 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/128 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
0.77%
1/130 • Number of events 1 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
Other adverse events
| Measure |
Levofloxacin 1 Tablet 500 mg Once a Day
n=128 participants at risk
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.
|
Prulifloxacin 1 Tablet 600 mg Once a Day
n=130 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.78%
1/128 • Number of events 1 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
1.5%
2/130 • Number of events 3 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/128 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
0.77%
1/130 • Number of events 1 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
|
Nervous system disorders
Psychomotor agitation
|
0.00%
0/128 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
0.77%
1/130 • Number of events 1 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
muscular pain
|
0.00%
0/128 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
0.77%
1/130 • Number of events 1 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/128 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
0.77%
1/130 • Number of events 1 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
|
Gastrointestinal disorders
Acute enteritis
|
0.00%
0/128 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
0.77%
1/130 • Number of events 1 • 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
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place