Prospective Cohort Study of Molecular Mechanism of Lower Respiratory Tract Microbes in Patients With AECOPD

NCT04259736 | Unknown DMC

• 1 other identifier: KY2018-362
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

How to reduce the rapid decline of lung function in patients with AECOPD is a clinically urgent problem to be solved. Studies have suggested that there is a bacterial flora imbalance in the lower respiratory tract of COPD patients. To explore the relationship between microbiology and host immunity is a hot topic in the field of COPD. The investigators use NGS (next generation sequencing) technology to fully explore the specific molecular mechanism of the lower respiratory tract microbiome in patients with COPD by regulating the transcriptional activities of NF-κB and PPARγ in alveolar macrophages, resulting in pulmonary parenchymal remodeling and decreased lung function. In this study, a prospective cohort study will be used to evaluate the effect of the lower respiratory tract microbiome on lung tissue (alveolar space and pulmonary vascular) remodeling and pulmonary function decline in patients with AECOPD.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Microbiome

Keywords

Lower Respiratory Tract; Microbes; COPD

Outcome Measures

Primary Outcomes (1)

• FEV1

  Forced expiratory volume in the first second

  12 months

Secondary Outcomes (4)

• CAT scores

  12 months

• mMRC scores

  12 months

• other lung function parameters

  12 months

• Incidence of COPD exacerbation

  12 months

Eligibility Criteria

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

Study Population

Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. Patients will be followed up every 3 months for a period of 1 year.

You may qualify if:

• Patients with a diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) according to the GOLD2018 guidelines (patients with FEV1pred\> 30% and no concurrent respiratory failure);
• Age ≥18, ≤80 years, regardless of gender;
• No antibiotics have been used after this acute exacerbation;
• Treatment according to GOLD guidelines;
• Those with the following bronchoscopy indications:
• Collect lower respiratory tract secretions for bacteriological examination;
• Chest radiographs have invasive lesions of unknown origin;
• bronchoalveolar lavage, bronchial administration and suction treatment;
• unexplained hemoptysis or chronic irritating cough;
• Bronchial obstructions such as localized wheezing, localized emphysema, obstructive pneumonia, or any atelectasis;
• Suspected of trachea and bronchial tumors;
• paralysis of the recurrent laryngeal or phrenic nerve of unknown cause;
• Cancer cells or Mycobacterium tuberculosis are found in sputum and no lesions are found on chest radiograph;
• Suspected of bronchial foreign bodies or stones;
• diffuse lesions of the lungs or masses around the lungs that require lung biopsy, brushing, or lavage for cytology or bacteriological examination to confirm the diagnosis;

You may not qualify if:

• active phase of tuberculosis;
• Patients with malignant tumor disease;
• patients with rheumatic diseases;
• Patients with contraindications to bronchoscopy;
• patients with mental illness;
• Exclude those with severe medical diseases: such as heart, liver, and kidney dysfunction or coagulation dysfunction; uncontrolled hypertension, hyperglycemia or arrhythmia;
• pregnancy and lactation;
• Patients who participated in other clinical trials in the past 3 months;
• Staff members and their families in this research institution.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital,Fudan university

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens include blood specimens and alveolar lavage fluid, used to detect blood routine, peripheral blood inflammatory factors (IL-8, TNF-α, IL-17), alveolar tube lavage microorganisms, and alveolar lavage fluid inflammatory factors (NF- κB, PPARγ, MMP-12, TIMP-4).

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Shengqing Li, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengqing Li, PhD

CONTACT

+8602152887072; shengqingli9655@163.com

Jingwen Xia, MD

CONTACT

+8602152887072; xjw2006@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Professor

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

CN (1)