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Prevention of exacerbation in patients with moderate-to-very severe COPD with the intent to modulate respiratory
Jian-Lan Hua1, Zi-Feng Yang2, Qi-Jian Cheng3
1Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Introduction:
Considering the role of bacteria in the onset of acute exacerbation of COPD (AECOPD), we hypothesized that the use of influenza-Streptococcus pneumoniae vaccination, oral probiotics or inhaled amikacin could prevent AECOPD.
Methods:
In this pilot prospective, muti-central, randomized trial, moderate-to-very severe COPD subjects with a history of moderate-to-severe exacerbations in the previous year were enrolled and assigned in a ratio of 1:1:1:1 into 4 groups. All participants were managed based on the conventional treatment recommended by GOLD 2019 report for 3 months, with three groups receiving additional treatment of inhaled amikacin (0.4 g twice daily, 5-7 days monthly for 3 months), oral probiotic Lactobacillus rhamnosus GG (1 tablet daily for 3 months), or influenza-S. pneumoniae vaccination. The primary endpoint was time to the next onset of moderate-to-severe AECOPD from enrollment. Secondary endpoints included CAT score, mMRC score, adverse events, and survival in 12 months.
Results:
Among all 112 analyzed subjects (101 males, 96 smokers or ex-smokers, mean ± SD age 67.19 ± 7.39 years, FEV1 41.06 ± 16.09% predicted), those who were given dual vaccination (239.7 vs. 198.2 days, p = 0.044, 95%CI [0.85, 82.13]) and oral probiotics (248.8 vs. 198.2 days, p = 0.017, 95%CI [7.49, 93.59]) had significantly delayed onset of next moderate-to-severe AECOPD than those received conventional treatment only. For subjects with high symptom burden, the exacerbations were significantly delayed in inhaled amikacin group as compared to the conventional treatment group (237.3 vs. 179.1 days, p = 0.009, 95%CI [12.40,104.04]). The three interventions seemed to be safe and well tolerated for patient with stable COPD.
Conclusion:
The influenza-S. pneumoniae vaccine and long-term oral probiotic LGG can significantly delay the next moderate-to-severe AECOPD. Periodically amikacin inhalation seems to work in symptomatic patients. The findings in the current study warrants validation in future studies with microbiome investigation.Clinical trial registration:https://clinicaltrials.gov/, identifier NCT03449459.
Insights
Influenza-Streptococcus pneumoniae vaccination and oral probiotics significantly delay acute exacerbations in COPD (AECOPD). These interventions, along with inhaled amikacin for symptomatic patients, show promise in preventing AECOPD and are well-tolerated.
Area of Science:
- Respiratory Medicine
- Infectious Diseases
- Microbiology
Background:
- Bacterial infections play a role in the onset of acute exacerbations of chronic obstructive pulmonary disease (AECOPD).
- Preventive strategies are needed to reduce the frequency and severity of AECOPD.
- Current management relies on conventional treatments, but additional interventions may offer benefits.
Purpose of the Study:
- To investigate the efficacy of influenza-Streptococcus pneumoniae vaccination, oral probiotics (Lactobacillus rhamnosus GG), and inhaled amikacin in preventing AECOPD.
- To evaluate the impact of these interventions on time to next AECOPD, symptom burden, and survival.
- To assess the safety and tolerability of these interventions in patients with stable COPD.
Main Methods:
- A pilot prospective, multi-center, randomized trial involving moderate-to-very severe COPD subjects with a history of exacerbations.
- Participants were assigned to four groups: conventional treatment alone or with additional influenza-S. pneumoniae vaccination, oral probiotics, or inhaled amikacin.
- The primary endpoint was time to the next moderate-to-severe AECOPD; secondary endpoints included CAT and mMRC scores, adverse events, and survival.
Main Results:
- Both dual vaccination and oral probiotics significantly delayed the onset of moderate-to-severe AECOPD compared to conventional treatment alone.
- Inhaled amikacin significantly delayed exacerbations in patients with a high symptom burden.
- All three interventions were found to be safe and well-tolerated in patients with stable COPD.
Conclusions:
- Influenza-S. pneumoniae vaccination and long-term oral probiotic LGG are effective in significantly delaying AECOPD.
- Periodical inhaled amikacin may be beneficial for symptomatic COPD patients.
- Further studies, including microbiome investigations, are warranted to validate these findings.
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