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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

December 1, 2018

Primary Completion Date

December 1, 2020

Study Completion Date

December 1, 2020

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DIETARY_SUPPLEMENT

oral probiotics

"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."

DRUG

aerosol inhaled amikacin

"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."

BIOLOGICAL

combined vaccination

"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."

Trial Locations (3)

Unknown

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

Ruijin Hospital, Shanghai Jiao Tong University, Shanghai

Shanghai Zhongshan Hospital, Shanghai

All Listed Sponsors
collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

collaborator

Ruijin Hospital

OTHER

lead

Shanghai Zhongshan Hospital

OTHER

NCT03449459 - Prevention of Acute Exacerbation in Subjects With COPD by Bacterial Decolonization in Lower Respiratory Tract | Biotech Hunter | Biotech Hunter