Who is sponsoring NCT01710488?

NCT01710488 is sponsored by Fadoi Foundation, Italy.

What drugs are being tested in NCT01710488?

Interventions in NCT01710488: Levofloxacin 1 tablet 500 mg once a day, Prulifloxacin 1 tablet 600 mg once a day.

What condition does NCT01710488 study?

NCT01710488 studies COPD Exacerbation.

Is NCT01710488 still recruiting?

NCT01710488 is currently completed. Last updated 16 January 2025.

Are results published for NCT01710488?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-16 · How we verify

NCT01710488: FLOR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 16 January 2025

What this trial tests

Phase 4 trial testing Levofloxacin 1 tablet 500 mg once a day in COPD Exacerbation in 258 participants. Completed in 1 November 2013.

Timeline

1 May 2009

Primary endpoint
1 November 2013

1 November 2013

Quick facts

Lead sponsor	Fadoi Foundation, Italy
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	258
Start date	1 May 2009
Primary completion	1 November 2013
Estimated completion	1 November 2013
Sites	25 locations across Italy

Drugs / interventions tested

Levofloxacin 1 tablet 500 mg once a day — full drug profile →
Prulifloxacin 1 tablet 600 mg once a day — full drug profile →

Conditions studied

COPD Exacerbation — all drugs for COPD Exacerbation →

Sponsor

Fadoi Foundation, Italy

Who can join

60 and older, any sex, with COPD Exacerbation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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 symp

Sponsor's own 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). 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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for COPD Exacerbation

Currently open trials in the same condition.

NCT07351929 — Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD · NA · recruiting
NCT05703919 — Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease · Phase 4 · recruiting
NCT06347536 — Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease · Phase 3 · recruiting
NCT06691399 — Role of Oral Care in Prevention of Nosocomial Pneumonia Among COPD Patients · NA · recruiting
NCT05958563 — Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA · NA · recruiting

Other Fadoi Foundation, Italy trials

Trials by the same sponsor.

NCT05239988 — Observational Study in COVID-19 Patients Treated With Remdesivir · completed
NCT05247931 — Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study · unknown
NCT04257422 — Intentional Rounding in Internal Medicine · NA · terminated
NCT06293768 — Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T) · NA · completed
NCT04589533 — MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study) · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01710488 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fadoi Foundation, Italy
Last refreshed: 16 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01710488.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing