A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT05400369 | Completed Phase 4

• 1 other identifier: DSCN-GRV AECOPD-CSIS-001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

COPD Exacerbation Acute

Keywords

Chronic obstructive pulmonary disease; Exacerbation; Sitafloxacin

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Clinical Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

  Clinical efficacy is divided into clinical cure and clinical ineffective. Clinical cure is defined as the three main symptoms of AECOPD (worsening dyspnea, increased sputum volume and sputum purulence) that disappear or return to the baseline level of stable phase at the end of treatment/discontinuation and no additional systemic antibacterial therapy is required for the target indication. Clinical ineffective is defined as the three main symptoms of AECOPD (worsening dyspnea, increased sputum volume and sputum purulence) that persist or incompletely disappear (do not return to the baseline level of stable phase).

  End of treatment (approximately Day 10 post-dose)

Secondary Outcomes (6)

• Number of Participants Achieving Clinical Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

  1 month post-dose

• Number of Participants Achieving Microbiological Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

  End of treatment (approximately Day 10 post-dose)

• Number of Days With Symptom Relief in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

  From the start of treatment up to relief of three main symptoms of AECOPD (worsening dyspnea, increased sputum volume and sputum purulence), up to 1 month post-dose

• Change from Baseline in Each Chronic Obstructive Pulmonary Disease Symptom Score in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

  End of treatment (approximately Day 10 post-dose)

• Change from Baseline in Inflammatory Biomarker C-reactive Protein in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

  End of treatment (approximately Day 10 post-dose)

Study Arms (2)

Sitafloxacin

EXPERIMENTAL

Adult participants who will be randomized to receive 100 mg sitafloxacin (2 tablets) orally once a day.

Drug: Sitafloxacin

Moxifloxacin

ACTIVE COMPARATOR

Adult participants who will be randomized to receive 400 mg moxifloxacin (1 tablet) orally every 24 hours.

Drug: Moxifloxacin Hydrochloride

Interventions

Sitafloxacin DRUG

Oral administration, 50 mg tablets

Also known as: Gracevit

Sitafloxacin

Moxifloxacin Hydrochloride DRUG

Oral administration, 400 mg tablets

Also known as: Avelox

Moxifloxacin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40;
• History of moderate to very severe COPD with a post-bronchodilator Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) \< 70% and a post-bronchodilator Forced Expiratory Volume in One Second (FEV1) \< 80% of predicted normal value within one year prior to enrollment;
• History of one or more acute exacerbations within one year prior to enrollment;
• At least 6 weeks of stable disease prior to enrollment;
• The acute exacerbation is classified as Anthonisen I (with 3 main symptoms of worsening dyspnea, increased sputum volume and sputum purulence) or II (with sputum purulence and another main symptom);
• Participants can be treated on an outpatient basis after clinical assessment.

You may not qualify if:

• Anthonisen III acute exacerbation (Have two major symptoms of worsening dyspnea and increased sputum volume or one of the two major symptoms)
• Hospitalization or intensive care unit (ICU) treatment is required
• Sputum culture within the previous year indicated the presence of pathogenic microorganisms resistant to quinolones
• Quinolone allergy
• History of QTc prolongation, or need for medications to treat QTc prolongation (e.g., Class Ia or Class III antiarrhythmics);
• Definite pulmonary disease other than COPD (asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, pulmonary fibrosis, lung cancer)
• History of severe cardiovascular disease (e.g., congestive heart failure, clinically significant coronary heart disease, stroke, myocardial infarction and/or stroke within 6 months, clinically significant arrhythmia, previous history of aortic aneurysm or aortic dissection, positive family history, or risk factors (e.g., Marfan syndrome), poorly controlled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg on 2 or more consecutive measurements)
• Severe systemic diseases, such as severe dizziness, headache and other nervous system diseases
• Malignant tumor
• Concomitant or history of tendon disease or myasthenia gravis or Parkinson's disease
• Abnormal liver function, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level \> 3 times the upper limit of normal, and/or total bilirubin level \>2 times the upper limit of normal
• With moderate or severe decline of renal function, endogenous creatinine clearance rate (Ccr) \< 50ml/min
• History of seizure, or psychiatric condition that could affect compliance with the protocol, or risk for suicide, or history of alcohol or illicit drug abuse
• Immunocompromised participants using glucocorticoids (total dose equivalent to prednisone 20 mg daily for more than 2 weeks) or immunosuppressive agents or HIV infected participants
• Gastrointestinal disorders that may affect drug absorption (e.g., active Crohn's disease, active ulcerative colitis)

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (18)

Peking University Shougang Hospital

Beijing, 100144, China

Location

The Third Xiangya Hospital of Central South University

Changsha, 410013, China

Location

The Sixth People's Hospital of Chengdu

Chengdu, 610000, China

Location

West China Hospital Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

Location

Fuyang People's Hospital

Fuyang, 236000, China

Location

Nanfang Hospital Southern Medical University

Guangzhou, 510510, China

Location

Qilu Hospital of Shandong University

Jinan, 250012, China

Location

Gaozhou People's Hospital

Maoming, 525200, China

Location

Huadong Hospital Affiliated To Fudan University

Shanghai, 200433, China

Location

Shenzhen People's Hospital

Shenzhen, 518140, China

Location

Tianjin Medical University General Hospital

Tianjin, 300070, China

Location

The Sixth Hospital of Wuhan

Wuhan, 430000, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430030, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, 221004, China

Location

The First Affiliated Hospital of Hebei North University

Zhangjiakou, 075001, China

Location

Affiliated Hospital of Guangdong Medical University

Zhanjiang, 523710, China

Location

Henan Provincial People's Hospital

Zhengzhou, 450003, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

sitafloxacin; Moxifloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Global Clinical Director

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: August 10, 2022
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

CN (18)