COPD Exacerbation AcutePhase 4NCT05400369
A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Sitafloxacin and Moxifloxacin Hydrochloride in people with COPD Exacerbation Acute, run by Daiichi Sankyo at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation Acute
- What is being tested?
- Sitafloxacin and Moxifloxacin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 18 sitesChina
- Study dates
- 10 Aug 2022to 25 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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 locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Peking University Shougang Hospital
Beijing, 100144
The Third Xiangya Hospital of Central South University
Changsha, 410013
The Sixth People's Hospital of Chengdu
Chengdu, 610000
West China Hospital Sichuan University
Chengdu, 610041
The First Affiliated Hospital of Dalian Medical University
Dalian, 116011
Fuyang People's Hospital
Fuyang, 236000
Nanfang Hospital Southern Medical University
Guangzhou, 510510
Qilu Hospital of Shandong University
Jinan, 250012
Gaozhou People's Hospital
Maoming, 525200
Huadong Hospital Affiliated To Fudan University
Shanghai, 200433
Shenzhen People's Hospital
Shenzhen, 518140
Tianjin Medical University General Hospital
Tianjin, 300070
The Sixth Hospital of Wuhan
Wuhan, 430000
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430030
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221004
The First Affiliated Hospital of Hebei North University
Zhangjiakou, 075001
Affiliated Hospital of Guangdong Medical University
Zhanjiang, 523710
Henan Provincial People's Hospital
Zhengzhou, 450003
About this study
Official title: 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
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.
Read the 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.
- Conditions
- COPD Exacerbation Acute
- Being tested
- Sitafloxacin, Moxifloxacin Hydrochloride
- Keywords
- Chronic obstructive pulmonary disease, Exacerbation, Sitafloxacin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitafloxacinDrug
Also called Gracevit
Oral administration, 50 mg tablets
Moxifloxacin HydrochlorideDrug
Also called Avelox
Oral administration, 400 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Sitafloxacin | Experimental | Adult participants who will be randomized to receive 100 mg sitafloxacin (2 tablets) orally once a day. Receives: Drug: Sitafloxacin |
| Moxifloxacin | Active comparator | Adult participants who will be randomized to receive 400 mg moxifloxacin (1 tablet) orally every 24 hours. Receives: Drug: Moxifloxacin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 1 month post-dose
Number of Participants Achieving Microbiological Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Microbiological efficacy is determined by bacterial clearance:
Clearance is defined as specimens from the original infection site after treatment do not culture pathogenic bacteria from the original infection.
Measured: End of treatment (approximately Day 10 post-dose)
Number of Days With Symptom Relief in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
The number of days with symptom relief of the three main symptoms of AECOPD (worsening dyspnea, increased sputum volume and sputum purulence) will be assessed.
Measured: 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
Chronic obstructive pulmonary disease symptom scores include dyspnea (ranging from 0 [Dyspnea only with strenuous activity] to 4 [Unable to leave home due to severe respiratory distress, or dyspnea when wearing and undressing]), sputum volume (ranging from 0 [no sputum] to 3 [severe]), sputum purulence (ranging from 0 [myxoid sample] to 3 [severe purulent]), cough score (ranging from 0 [no cough] to 3 [severe cough]), fever (ranging from 0 [≤37.0°C] to 3 [>38.0°C], and COPD Assessment Test (CAT) (where questions 1-8, range from a score of 0 [no impact] to 5 [severely impacted]. For all assessments, higher scores indicate worse outcome.
Measured: 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
Measured: End of treatment (approximately Day 10 post-dose)
Recurrence Rate of Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Recurrence rate is defined as when the clinical outcome of the participant at the end/discontinuation of treatment is determined to be clinically cured, but AECOPD occurs again within 20 days after drug withdrawal due to incomplete anti-infective treatment, the participant develops one or more of the three main symptoms of worsening dyspnea, increased phlegm production, and sputum production, and also has relevant signs of AECOPD, with repeated blood routine, C-reactive protein and other inflammatory indicators, and needs to receive systemic antibacterial drug treatment again, and the pathogenic bacteria belonged to the same strain and serotype as the bacteria originally infected.
Measured: End of treatment (approximately Day 10 post-dose) up to 1 month post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start10 Aug 2022
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Director, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400369
- Sponsor's protocol ID
- DSCN-GRV AECOPD-CSIS-001
- Status last verified
- Jan 2025
- First submitted
- 27 May 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05400369
- Acronym / sponsor ID
- DSCN-GRV AECOPD-CSIS-001
- Conditions
- COPD Exacerbation Acute
- Keywords
- Chronic obstructive pulmonary disease, Exacerbation, Sitafloxacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitafloxacin | Experimental | Drug: SitafloxacinAdult participants who will be randomized to receive 100 mg sitafloxacin (2 tablets) orally once a day. |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin HydrochlorideAdult participants who will be randomized to receive 400 mg moxifloxacin (1 tablet) orally every 24 hours. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (20 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitafloxacinAlso: GracevitOral administration, 50 mg tablets | Drug | Sitafloxacin |
| Moxifloxacin HydrochlorideAlso: AveloxOral administration, 400 mg tablets | Drug | Moxifloxacin |
Primary outcome
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).
6 secondary outcomes
Number of Participants Achieving Clinical Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time frame: 1 month post-dose
Number of Participants Achieving Microbiological Efficacy in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time frame: End of treatment (approximately Day 10 post-dose)
Number of Days With Symptom Relief in Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time frame: 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
Time frame: 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
Time frame: End of treatment (approximately Day 10 post-dose)
Recurrence Rate of Participants With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time frame: End of treatment (approximately Day 10 post-dose) up to 1 month post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director study director
Daiichi Sankyo
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitafloxacin and Moxifloxacin Hydrochloride in people with COPD Exacerbation Acute, run by Daiichi Sankyo at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.