Last reviewed · How we verify
NCT05400369
A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Phase 4 trial testing Sitafloxacin in COPD Exacerbation Acute in 140 participants. Completed in 25 September 2024.
25 September 2024
Quick facts
| Lead sponsor | Daiichi Sankyo |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 10 August 2022 |
| Primary completion | 25 September 2024 |
| Estimated completion | 25 September 2024 |
| Sites | 18 locations across China |
Drugs / interventions tested
- Sitafloxacin (SITAFLOXACIN) — full drug profile →
- Moxifloxacin Hydrochloride — full drug profile →
Conditions studied
- COPD Exacerbation Acute — all drugs for COPD Exacerbation Acute →
Sponsor
Daiichi Sankyo — full company profile →
Who can join
40 and older, any sex, with COPD Exacerbation Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease, that causes obstructed airflow from the lungs that causes persistent obstructive airflow limitation. Acute exacerbation, especially frequent exacerbation, is associated with an increased risk of death in COPD patients. The most common causes of acute attacks are viral and bacterial infections. This study will assess the efficacy and safety of sitafloxacin, a quinolone antibacterial drug, in participants with AECOPD.
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:
- PubMed search for NCT05400369
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sitafloxacin
Trials testing the same drug.
- NCT06809413 — Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease · Phase 2 · enrolling by invitation
- NCT05454345 — Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment · Phase 3 · not yet recruiting
Other recruiting trials for COPD Exacerbation Acute
Currently open trials in the same condition.
- NCT05703919 — Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease · Phase 4 · recruiting
- NCT06274957 — The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation · NA · recruiting
- NCT06331416 — Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation · NA · recruiting
- NCT05452226 — Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia · NA · recruiting
- NCT05568043 — The Reducing REVISITS Study: A Cluster RCT · NA · recruiting
Other Daiichi Sankyo trials
Trials by the same sponsor.
- NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events · Phase 3 · not yet recruiting
- NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero · active not recruiting
- NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies · Phase 1, PHASE2 · recruiting
- NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv · Phase 1 · completed
- NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05400369 (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 Daiichi Sankyo
- Last refreshed: 9 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/NCT05400369.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing