Prevention of Acute Exacerbation in Subjects With COPD by Bacterial Decolonization in Lower Respiratory Tract

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The colonization of potential pathogenic bacteria in lower respiratory tract is thought to be accountable for acute exacerbation in subjects with moderate to severe COPD. However, there is no accepted therapy for patients with COPD to remove the colonized bacteria in lower respiratory tract. Therefore, we plan to perform a multi-center, randomized, controlled trial to study the efficacy and safety of oral probiotics, aerosol inhaled amikacin or combined vaccination to decolonize bacteria in lower respiratory tract and prevent acute exacerbation of COPD.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Ruijin Hospital; The First Affiliated Hospital of Guangzhou Medical University
• Treatments: Amikacin; Vaccines

Criteria

Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed

2. Male or female adults aged 18-65 years

3. Diagnosed with COPD according to GOLD 2016 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC)<0.70 with the use of salbutamol 400ug)

4. Moderate to very severe airflow limitation (post-bronchodilator FEV1 < 80% of the predicted normal value)

5. A documented history of at least 2 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics, or at least 1 exacerbation in the previous 12 months that requires hospitalization.

6. In the stable stage of COPD

Exclusion Criteria:

1. Patients who have clinically significant and chronic hepatic, renal, cardiovascular and gastrointestinal abnormalities or malignant tumor (except for lung cancer) which could interfere with the assessment of the efficacy and safety of the study treatment

2. Patients who are in critical conditions

3. Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids or an acute exacerbation of any other diseases in the 4 weeks prior to screening

4. Patients with concomitant pulmonary disease (including but not limited to bronchiectasis, interstitial lung disease, asthma)

5. Patients who are highly likely to be lost during the 3-month treatment and the 1-year follow up

6. Pregnant or nursing (lactating) women

7. Patients who have been vaccinated against influenza in the current year, or against Streptococcus pneumoniae within five years, or have vaccination contraindications

8. Patients who are allergic to amikacin or other aminoglycosides

9. Patients who have participated in any interventional clinical trials in the three months prior to screening

10. Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up