Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— PAEANOfficial title:
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.
Verified date | November 2018 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
China | Ruijin Hospital, Shanghai Jiao Tong University | Shanghai | Shanghai |
China | Shanghai Zhongshan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital | Ruijin Hospital, The First Affiliated Hospital of Guangzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Colonization of potential pathogenic bacteria in induced sputum | Induced sputum represents the specimen from lower respiratory tract and should be processed within six hours after collection. Sputum plugs were separated from contaminating saliva by macroscopic examination using sterile forceps. Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis and Pseudomonas aeruginosa which are the top four bacteria involved in acute exacerbation of COPD are defined as potential pathogenic bacteria. Using the plate count method, when the colony number of above four bacteria is over 100 cfu/ml,we define this bacteria as colonized bacteria in lower respiratory tract. | Baseline, 3 months | |
Secondary | Microbiome in induced sputum | Induced sputum represents the specimen from lower respiratory tract and should be processed within six hours after collection. Sputum plugs were separated from contaminating saliva by macroscopic examination using sterile forceps and weighed. Bacterial genomic DNA was isolated from sputum plugs of the same weight using the specific kits. The 16S bacterial ribosomal RNA genes were Polymerase Chain Reaction (PCR)-amplified with the appropriate controls against reagent contamination. Amplified DNA fragments were sequenced using the specific sequencing platform. Sequencing reads were processed and analyzed by the specific algorithm and software. The composition and diversity of microbiome are represented by major taxonomic groups at both phylum and genus levels. If necessary, Quantitative PCR for 16S rRNA gene will be performed to validate the results of sequencing. By using these methos, we can detect the microbiome's composition and its shift. | Baseline, 3 months | |
Secondary | Forced Expiratory Volume in 1 Second | Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. FEV1 was measured after 15 minutes of inhaling salbutamol 400ug. | Baseline, 3 months, 15 months | |
Secondary | COPD Assessment Test(CAT) Score | The COPD Assessment Test (CAT) is an 8-item uni-dimensional measure of health status impairment in COPD, containing 6 grades from 0 to 5. | Baseline, 3 months, 6 months, 9 months, 12 months, 15 months | |
Secondary | modified Medical Research Council(mMRC) scale | The modified Medical Research Council scale is a simple and powerful tool to evaluate the breathlessness, containing 5 grades from 0 to 4. | Baseline, 3 months, 6 months, 9 months, 12 months, 15 months | |
Secondary | serum C-reactive protein(CRP) levels | Serum CRP level is a sensitive marker of the systemic inflammation. | Baseline, 3 months | |
Secondary | interleukin(IL)-6 in induced sputum | Induced sputum represents the specimen from lower respiratory tract. Sputum supernatant was batch analysed for the cytokines IL-6 using commercial highsensitivity sandwich ELISA kits. Inflammatory factors represent local inflammation levels in lower respiratory tract. | Baseline, 3 months | |
Secondary | IL-8 in induced sputum | Induced sputum represents the specimen from lower respiratory tract. Sputum supernatant was batch analysed for the cytokines IL-8 using commercial highsensitivity sandwich ELISA kits. Inflammatory factors represent local inflammation levels in lower respiratory tract. | Baseline, 3 months | |
Secondary | IL-1ß in induced sputum | Induced sputum represents the specimen from lower respiratory tract. Sputum supernatant was batch analysed for the cytokines IL-1ß using commercial highsensitivity sandwich ELISA kits. Inflammatory factors represent local inflammation levels in lower respiratory tract. | Baseline, 3 months | |
Secondary | Number of Patients With Adverse Events, Serious Adverse Events, and Death | The overall rate of adverse events reported from initiation to the last time follow-up. Some laboratory examinations, such as blood routine, hepatorenal function and electrocardiogram, are performed twice separately at baseline and completion of intervention(3 months) in order to evaluate the safety of interventions. | Baseline, 3 months, 6 months, 9 months, 12 months, 15 months |
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