Inhaled Amikacin in Preventing AECOPD

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 strong evidence on the effect of LRT bacterial decolonization on COPD. This study was designed to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Amikacin

Criteria

Inclusion Criteria:

1. 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)

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:

1. Patients with concomitant pulmonary disease, including bronchiectasis, interstitial lung disease, asthma, etc.

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.