Completed
A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Led by Daiichi Sankyo · Updated on 2025-01-09
140
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
- Pregnant or lactating women or women of childbearing potential who are planning to become pregnant
- Participation in other clinical trials within 3 months prior to screening
- Used antibiotics (including systemic and inhalation) 30 days before enrollment
- Serum potassium < 3.5mmol/L at screening, or repeated hypokalemia that was difficult to correct in the past
- Other reasons that the investigator considered inappropriate to participate in the study.
Trial Site Locations
Total: 18 locations
1
Peking University Shougang Hospital
Beijing, China, 100144
Status Unknown
2
The Third Xiangya Hospital of Central South University
Changsha, China, 410013
Status Unknown
3
The Sixth People's Hospital of Chengdu
Chengdu, China, 610000
Status Unknown
4
West China Hospital Sichuan University
Chengdu, China, 610041
Status Unknown
5
The First Affiliated Hospital of Dalian Medical University
Dalian, China, 116011
Status Unknown
6
Fuyang People's Hospital
Fuyang, China, 236000
Status Unknown
7
Nanfang Hospital Southern Medical University
Guangzhou, China, 510510
Status Unknown
8
Qilu Hospital of Shandong University
Jinan, China, 250012
Status Unknown
9
Gaozhou People's Hospital
Maoming, China, 525200
Status Unknown
10
Huadong Hospital Affiliated To Fudan University
Shanghai, China, 200433
Status Unknown
11
Shenzhen People's Hospital
Shenzhen, China, 518140
Status Unknown
12
Tianjin Medical University General Hospital
Tianjin, China, 300070
Status Unknown
13
The Sixth Hospital of Wuhan
Wuhan, China, 430000
Status Unknown
14
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China, 430030
Status Unknown
15
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China, 221004
Status Unknown
16
The First Affiliated Hospital of Hebei North University
Zhangjiakou, China, 075001
Status Unknown
17
Affiliated Hospital of Guangdong Medical University
Zhanjiang, China, 523710
Status Unknown
18
Henan Provincial People's Hospital
Zhengzhou, China, 450003
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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