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
Overview
- Phase
- Phase 4
- Intervention
- Sitafloxacin
- Conditions
- COPD Exacerbation Acute
- Sponsor
- Daiichi Sankyo
- Enrollment
- 140
- Locations
- 18
- Primary Endpoint
- Number of Participants Achieving Clinical Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Status
- Completed
- Last Updated
- last year
Overview
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.
Detailed Description
Clinical evidence suggests that AECOPD may be an important factor in the cause of death in patients with COPD. AECOPD typically presents with increased dyspnea, cough, and sputum volume, or purulent changes in sputum. The most common factors of AECOPD are viral and bacterial infections. Anti-infection agents have shown to be effective in patients with infectious AECOPD. This study will assess the anti-bacterial drug sitafloxacin in participants with AECOPD. Clinical efficacy is the primary objective of the study. Microbiological validity, symptom relief, magnitude of change in symptom score and inflammatory biomarker, and recurrence rate and safety will also be assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Sitafloxacin
Adult participants who will be randomized to receive 100 mg sitafloxacin (2 tablets) orally once a day.
Intervention: Sitafloxacin
Moxifloxacin
Adult participants who will be randomized to receive 400 mg moxifloxacin (1 tablet) orally every 24 hours.
Intervention: Moxifloxacin Hydrochloride
Outcomes
Primary Outcomes
Number of Participants Achieving Clinical Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time Frame: End of treatment (approximately Day 10 post-dose)
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).
Secondary Outcomes
- 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))
- Recurrence Rate of Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease(End of treatment (approximately Day 10 post-dose) up to 1 month post-dose)