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This study looks at preventing acute flare-ups in patients with chronic obstructive pulmonary disease (COPD) by reducing bacteria in the lower airways, using oral probiotics, inhaled amikacin and combined vaccination. Patients aged 18-65 with COPD and moderate to very severe airflow limitation may take part. The study was conducted in Early Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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