Inhaled Amikacin in Preventing AECOPD

NCT05213507 | Unknown Phase 3

• 2 other identifiers: B2021-766DGF501035/017
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 5

Brief Summary

The underlying bacterial colonization in lower respiratory tract (LRT) of COPD patients may be related to acute exacerbation of COPD (AECOPD) and disease progression. However, there is a lack of strong evidence on the effect of LRT bacterial decolonization on COPD. This study was designed to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.

Conditions

COPD; COPD Exacerbation

Keywords

Amikacin; Respiratory Tract Diseases; Anti-Bacterial Agents; Anti-Infective Agents

Outcome Measures

Primary Outcomes (1)

• Time to the first COPD acute exacerbation

  COPD acute exacerbation refers to the deterioration of daily symptoms, which requires treatment with antibiotics or systemic glucocorticoid therapy. The first COPD acute exacerbations was defined as the date of occurrence of the first AECOPD starting from the day of the first dose to one day after the last visit.

  15 months

Secondary Outcomes (8)

• Number of the COPD acute exacerbations

  15 months

• Load of LRT colonized potential pathogenic bacteria in induced sputum

  Baseline, 3 months, 6 months, 9 months, 12 months, 15 months

• Minimum inhibitory concentration (MIC) of colonized potential pathogenic bacteria in induced sputum

  Baseline, 3 months, 6 months, 9 months, 12 months, 15 months

• Microbiome in induced sputum

  Baseline, 3 months, 6 months, 9 months, 12 months, 15 months

• Forced Expiratory Volume in 1 Second

  Baseline, 3 months, 15 months

Study Arms (2)

Inhaled Amikacin plus Conventional Therapy

EXPERIMENTAL

0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 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.

Drug: aerosol inhaled Amikacin Sulfate Injection; Other: conventional therapy

Conventional Therapy

OTHER

According to the subjects' personal characteristics and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled glucocorticoids and long-term oxygen therapy.

Other: conventional therapy

Interventions

aerosol inhaled Amikacin Sulfate Injection DRUG

0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months.

Also known as: Aerosol Inhaled investigation drug

Inhaled Amikacin plus Conventional Therapy

conventional therapy OTHER

According to the personal characteristics of subjects and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled corticosteroids and long-term oxygen therapy.

Also known as: Comparison Group

Conventional Therapy; Inhaled Amikacin plus Conventional Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with COPD according to GOLD 2021 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC) \< 0.70 with the use of 400ug salbutamol)
• Moderate to very severe airflow limitation (post-bronchodilator FEV1 \< 80% of the predicted value with the use of 400ug salbutamol)
• A documented history of at least twice AECOPD in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics.
• In the stable stage of COPD.
• At least once positive result of amikacin sensitive Gram-negative bacteria by semi-quantitative sputum culture, including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumonia, etc.
• Written informed consent must be obtained before any assessment is performed.
• Male or female adults aged 18-80 years.

You may not qualify if:

• Patients with concomitant pulmonary disease, including bronchiectasis, interstitial lung disease, asthma, etc.
• Patients with alpha-1 antitrypsin deficiency.
• Patients who have had AECOPD or acute exacerbation of any other diseases that required treatment with systemic glucocorticoids and/or antibiotics in the 4 weeks prior to screening.
• Patients with long-term oral corticosteroid use.
• Patients with Gram-negative bacterial infection requiring systemic treatment with antibiotics against Gram-negative bacteria.
• Patients who have participated in any interventional clinical trials in the 3 months prior to screening.
• Patients who are allergic to amikacin or other aminoglycosides.
• Patients who have chronic hepatic, renal and gastrointestinal abnormality or malignant tumor, except for lung cancer, which could interfere with the assessment of the efficacy and safety of the intervention.
• Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up.
• Patients at high risk of being lost during the 3-month treatment and the 1-year follow up.
• Pregnant or nursing (lactating) women.
• Patients who are in critical conditions.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (5)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Jingan District Central Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Fifth People's Hospital, Fudan University

Shanghai, Shanghai Municipality, 201100, China

Location

Qingpu Branch of Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 201799, China

Location

Wusong Branch of Shanghai Zhongshan hospital

Shanghai, Shanghai Municipality, 201900, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Zhang, MD, PhD

  Zhongshan hospital, Shanghai Medical College, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Zhang, MD, PhD

CONTACT

+86-13472782754; zhang.jing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

CN (5)