Status:
COMPLETED
Prevention of Acute Exacerbation in Subjects With COPD by Bacterial Decolonization in Lower Respiratory Tract
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Guangzhou Medical University
Ruijin Hospital
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by incomplete reversible airflow limitation, small airway obstruction and alveolar structural damage. About ...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any assessment is performed
- Male or female adults aged 18-65 years
- 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)
- Moderate to very severe airflow limitation (post-bronchodilator FEV1 \< 80% of the predicted normal value)
- 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.
- In the stable stage of COPD
Exclusion
- 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
- Patients who are in critical conditions
- 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
- Patients with concomitant pulmonary disease (including but not limited to bronchiectasis, interstitial lung disease, asthma)
- Patients who are highly likely to be lost during the 3-month treatment and the 1-year follow up
- Pregnant or nursing (lactating) women
- Patients who have been vaccinated against influenza in the current year, or against Streptococcus pneumoniae within five years, or have vaccination contraindications
- Patients who are allergic to amikacin or other aminoglycosides
- Patients who have participated in any interventional clinical trials in the three months prior to screening
- Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03449459
Start Date
December 1 2018
End Date
December 1 2020
Last Update
June 23 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
2
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
3
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China