Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
136 participants
INTERVENTIONAL
2022-03-31
2023-12-31
Brief Summary
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Detailed Description
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About 74% of stable COPD patients had underlying pathogen colonization, mainly Gram-negative bacteria, in lower respiratory tract (LRT). Bacterial colonization can damage the airways of COPD patients, leading to disease progression. Further disruption of airway defense mechanisms promotes the adhesion and growth of bacteria in reverse. Eventually, a vicious circle is formed between LRT bacterial colonization and the progression of COPD. Thus, moderate to severe COPD patients were more likely to have LRT colonization, and patients with higher load of LRT bacterial colonization tended to have more frequent acute exacerbations. Decolonization of LRT bacteria may be able to control the progression of COPD and prevent AECOPD through breaking the vicious circle.
Instead of proving that long-term use of antibiotics in stable stage of COPD can prevent AECOPD, previous clinical trials have found that it can lead to the development of severe adverse reactions and the growth of LRT drug-resistant bacteria. It is probably because the main colonized LTR bacteria were not sensitive to those investigational drugs. Additionally, drugs were delivered systematically in those previous studies. Theoretically, inhalation administration can deliver the drug directly to the lungs, leading to higher drug concentrations in the lungs and less occurrence of systemic adverse reactions. Therefore, inhalation administration can well make up for the deficiencies of systematic administration. Studies on cystic fibrosis and bronchiectasis have yielded promising results of the safety and effectiveness of inhaled antibiotics for LRT bacterial decolonization. As COPD has similar manifestations to the two diseases, the promising results indicated the feasibility of decolonization of LRT bacteria to prevent AECOPD.
Previously, a multicentral clinical trial conducted by our research team preliminarily investigated whether nebulized Amikacin combined with conventional therapy could prevent AECOPD and disease progression of COPD. However, whether decolonization of LRT bacteria plays a role in these process remains unknown. The main purpose of this research is to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Inhaled Amikacin plus Conventional Therapy
0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months.
In order to observe and cope with adverse events timely, subjects will be admitted to the ward during the course of medication.
Subjects will take conventional therapy at the same time.
aerosol inhaled Amikacin Sulfate Injection
0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months.
conventional therapy
According to the personal characteristics of subjects and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled corticosteroids and long-term oxygen therapy.
Conventional Therapy
According to the subjects' personal characteristics and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled glucocorticoids and long-term oxygen therapy.
conventional therapy
According to the personal characteristics of subjects and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled corticosteroids and long-term oxygen therapy.
Interventions
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aerosol inhaled Amikacin Sulfate Injection
0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months.
conventional therapy
According to the personal characteristics of subjects and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled corticosteroids and long-term oxygen therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Moderate to very severe airflow limitation (post-bronchodilator FEV1 \< 80% of the predicted value with the use of 400ug salbutamol)
3. A documented history of at least twice AECOPD in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics.
4. In the stable stage of COPD.
5. At least once positive result of amikacin sensitive Gram-negative bacteria by semi-quantitative sputum culture, including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumonia, etc.
6. Written informed consent must be obtained before any assessment is performed.
7. Male or female adults aged 18-80 years.
Exclusion Criteria
2. Patients with alpha-1 antitrypsin deficiency.
3. Patients who have had AECOPD or acute exacerbation of any other diseases that required treatment with systemic glucocorticoids and/or antibiotics in the 4 weeks prior to screening.
4. Patients with long-term oral corticosteroid use.
5. Patients with Gram-negative bacterial infection requiring systemic treatment with antibiotics against Gram-negative bacteria.
6. Patients who have participated in any interventional clinical trials in the 3 months prior to screening.
7. Patients who are allergic to amikacin or other aminoglycosides.
8. Patients who have chronic hepatic, renal and gastrointestinal abnormality or malignant tumor, except for lung cancer, which could interfere with the assessment of the efficacy and safety of the intervention.
9. Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up.
10. Patients at high risk of being lost during the 3-month treatment and the 1-year follow up.
11. Pregnant or nursing (lactating) women.
12. Patients who are in critical conditions.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Jing Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan hospital, Shanghai Medical College, Fudan University
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Jingan District Central Hospital
Shanghai, Shanghai Municipality, China
Shanghai Fifth People's Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Qingpu Branch of Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Wusong Branch of Shanghai Zhongshan hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Huifang Cao
Role: primary
Jingjing Li
Role: primary
Other Identifiers
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DGF501035/017
Identifier Type: OTHER
Identifier Source: secondary_id
B2021-766
Identifier Type: -
Identifier Source: org_study_id
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