Intestinal Microbiota in COPD and Asthma

NCT04802317 | Completed

• 1 other identifier: 03-08/20
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

The composition of the intestinal microbiota, the level of lipopolysaccharides, TMAO in the blood, and other parameters of patients with COPD (n=50), asthma (n=50) and the control (n=40) will be assessed as factors associated with exacerbations and respiratory symptoms in the prospective study (12 months).

Conditions

Chronic Respiratory Diseases

Keywords

intestinal microbiota; COPD; asthma; lipopolysaccharides; trimethylamine-N-oxide; course of the diseases; exacerbation

Outcome Measures

Primary Outcomes (1)

• Exacerbation of asthma / chronic obstructive pulmonary disease

  Number of patients with exacerbation of bronchial asthma or chronic obstructive pulmonary disease, number of exacerbation per year

  12 months

Study Arms (3)

Control

Health people without any respiratory diseases

Diagnostic Test: Identification of the composition of the intestinal microbiota

Bronchial asthma

Patients with asthma

Diagnostic Test: Identification of the composition of the intestinal microbiota

COPD

Patients with chronic obstructive pulmonary disease

Diagnostic Test: Identification of the composition of the intestinal microbiota

Interventions

Identification of the composition of the intestinal microbiota DIAGNOSTIC_TEST

Identification of the composition of the intestinal microbiota

Bronchial asthma; COPD; Control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients without COPD, asthma, chronic bronchitis and other lung diseases for control group. Patients asthma/COPD with for asthma/COPD groups.

You may qualify if:

• for control group:
• Normal spirometry results with bronchodilation test (salbutamol 400 mcg);
• Absence of COPD, asthma, chronic bronchitis and other lung diseases
• BMI\<40kg/m2
• for asthma/COPD groups:
• Primary medical documentation confirming the diagnosis of COPD or asthma
• Regular therapy for COPD, asthma and any chronic disease for at least 4 weeks prior to enrollment in this study.
• FEV1 / FVC \<0.70 after inhalation of 400 mcg of salbutamol for patients with COPD
• BMI\<40kg/m2

You may not qualify if:

• Exacerbation of chronic noninfectious diseases, including exacerbation of COPD / asthma, within 4 weeks prior to enrollment in this study.
• Exacerbation of COPD or asthma in the next 3 months, requiring the treatment of antibiotic therapy or systemic corticosteroids;
• Cerebral stroke, transient ischemic attack or myocardial infarction within 6 months before the date of enrollment in the study;
• Clinically significant chronic diseases (oncological, systemic diseases of the connective tissue, diseases of the blood system, heart failure, Crohn's disease, ulcerative colitis, etc. according to anamnesis);
• GFR \<30 ml / min / 1.73m2;
• Atopy in a patient with COPD or a control group (any allergic manifestations - skin, nasal, conjunctival, food, etc.);
• Chronic respiratory diseases in a patient of the control group (COPD, asthma, chronic bronchitis, interstitial lung diseases);
• History of organ transplantation;
• Mental illness;
• Intestinal infection (food poisoning) in the next 3 months;
• Other acute infectious diseases. It is possible to turn on not earlier than 4 weeks after complete recovery and cessation of treatment;
• History of severe COVID-19;
• HIV infection, chronic viral hepatitis according to the history;
• Clinically significant oncological disease;
• Pregnancy and lactation;

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead
• Center for Strategic Planning and Management of Biomedical Health Risks: collaborator

Study Sites (1)

NRCPM

Moscow, 101000, Russia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marina Smirnova, PhD, MD

  NRCPM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: June 23, 2020
• Primary Completion: June 30, 2023
• Study Completion: December 5, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

RU (1)