Status:
UNKNOWN
Inhaled Amikacin in Preventing AECOPD
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
COPD
COPD Exacerbation
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The underlying bacterial colonization in lower respiratory tract (LRT) of COPD patients may be related to acute exacerbation of COPD (AECOPD) and disease progression. However, there is a lack of stron...
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) has become the third leading cause of death all over the world. Frequent acute exacerbations can even increase the mortality of COPD. Therefore, preventing...
Eligibility Criteria
Inclusion
- Diagnosed with COPD according to GOLD 2021 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC) \< 0.70 with the use of 400ug salbutamol)
- Moderate to very severe airflow limitation (post-bronchodilator FEV1 \< 80% of the predicted value with the use of 400ug salbutamol)
- A documented history of at least twice AECOPD in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics.
- In the stable stage of COPD.
- At least once positive result of amikacin sensitive Gram-negative bacteria by semi-quantitative sputum culture, including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumonia, etc.
- Written informed consent must be obtained before any assessment is performed.
- Male or female adults aged 18-80 years.
Exclusion
- Patients with concomitant pulmonary disease, including bronchiectasis, interstitial lung disease, asthma, etc.
- Patients with alpha-1 antitrypsin deficiency.
- 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.
- Patients with long-term oral corticosteroid use.
- Patients with Gram-negative bacterial infection requiring systemic treatment with antibiotics against Gram-negative bacteria.
- Patients who have participated in any interventional clinical trials in the 3 months prior to screening.
- Patients who are allergic to amikacin or other aminoglycosides.
- 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.
- Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up.
- Patients at high risk of being lost during the 3-month treatment and the 1-year follow up.
- Pregnant or nursing (lactating) women.
- Patients who are in critical conditions.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05213507
Start Date
March 1 2022
End Date
December 1 2023
Last Update
February 23 2022
Active Locations (5)
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1
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200030
2
Shanghai Jingan District Central Hospital
Shanghai, Shanghai Municipality, China, 200040
3
Shanghai Fifth People's Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 201100
4
Qingpu Branch of Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 201799