PAEAN
A Randomized, Parallel, Controlled, Exploratory Study: the Efficacy and Safety of Taking Probiotics, Inhaled Antibiotics or Combined Vaccination to Prevent Acute Exacerbation in Subjects With Moderate to Severe COPD and Decolonize Bacteria in Lower Respiratory Tract.
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Ministry of science and technology of China.
interventional
144
1 country
3
Study Start
December 1, 2018
Actual (reported)Primary Completion
December 1, 2020
Actual (reported)Study Completion
December 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2018
Actual (reported)February 28, 2018
Actual (reported)December 1, 2018
Actual (reported)December 1, 2020
Actual (reported)December 1, 2020
Actual (reported)Time to the first COPD exacerbation
COPD exacerbation refers to deterioration of patients' daily symptoms requiring treatment with antibiotics or systemic glucocorticoid therapy. First COPD exacerbations starting between first dose and one day after last follow-up are included.
15 months
Colonization of potential pathogenic bacteria in induced sputum
Baseline, 3 months
Microbiome in induced sputum
Baseline, 3 months
Forced Expiratory Volume in 1 Second
Baseline, 3 months, 15 months
COPD Assessment Test(CAT) Score
Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
modified Medical Research Council(mMRC) scale
Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Culturelle™ DIGESTIVE HEALTH 30 CT(VCAP)(10 Billion Claim) which consists of 100% Lactobacillus rhamnosus GG, 1 tablet, q.d., for 3 months. Subjects will take conventional therapy at the same time.
0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 5-7 days per month, for 3 months. In order to observe and cope with adverse events timely, subjects will be admitted to the ward during the course of medication. Subjects will take conventional therapy at the same time.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Hua JL, Yang ZF, Cheng QJ, Han YP, Li ZT, Dai RR, He BF, Wu YX, Zhang J. Prevention of exacerbation in patients with moderate-to-very severe COPD with the intent to modulate respiratory microbiome: a pilot prospective, multi-center, randomized controlled trial. Front Med (Lausanne). 2024 Jan 5;10:1265544. doi: 10.3389/fmed.2023.1265544. eCollection 2023.
Jing Zhang, MD, PhD
Shanghai Zhongshan Hospital
144 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2018
First Posted
February 28, 2018
Study Start
Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)
According to the subjects' personal characteristics and guidance of The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2017, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled glucocorticoids and long term oxygen therapy.
Influenza Vaccine recommended by World Health Organization(WHO) in that year and imported 23-Valent Pneumococcal Polysaccharide Vaccine approved by China Food and Drug Administration(CFDA) are vaccinated at different body sites by professional nurses. The interval between two vaccinations is 3-5 days to avoid the overlap of adverse events. Subjects will take conventional therapy at the same time.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
December 1, 2018
Actual (reported)Primary Completion
December 1, 2020
Actual (reported)Study Completion
December 1, 2020
Actual (reported)Last Updated
June 23, 2022
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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