Prevention of Acute Exacerbation in Subjects with Moderate-to-very Severe COPD by Modulating Lower Respiratory Microbiome: Protocol of a Prospective, Multicenter, Randomized Controlled Trial.
Jian-Lan HuaWei-Ping HuYi-Hui ZuoQunying HongPublished in: International journal of chronic obstructive pulmonary disease (2020)
We hypothesize that patients with stable COPD will benefit from aerosol-inhaled amikacin, oral probiotics or combined vaccination in terms of preventing acute exacerbation of COPD, slowing the progression of the disease and improving their quality of life. The trial aimsto investigate the efficacy and safety of the above interventions to decolonize bacteria in the lower respiratory tract and prevent acute exacerbation of COPD. In the study, 144 patients with stable phase of moderate-to-very severe COPD will be recruited and randomized into aerosol-inhaled amikacin group, oral probiotics group, combined vaccination group and the control group at a 1:1:1:1 ratio. The primary outcome is time to the first COPD exacerbation. Other endpoints include colonization of potential pathogenic bacteria in induced sputum, microbiome in induced sputum, pulmonary function and symptoms of patients, inflammation level and adverse events, serious adverse events, and death.
Keyphrases
- chronic obstructive pulmonary disease
- lung function
- drug induced
- randomized controlled trial
- cystic fibrosis
- liver failure
- respiratory failure
- respiratory tract
- end stage renal disease
- mycobacterium tuberculosis
- study protocol
- high glucose
- chronic kidney disease
- oxidative stress
- ejection fraction
- diabetic rats
- early onset
- phase iii
- peritoneal dialysis
- aortic dissection
- pulmonary tuberculosis
- double blind
- open label
- systematic review
- risk assessment
- clinical trial
- physical activity
- endothelial cells
- water soluble
- signaling pathway
- placebo controlled
- patient reported outcomes
- depressive symptoms
- human health
- prognostic factors