The Clinical Value of the Nitric Oxide System Components in Asthma and COPD

NCT04456491 | Unknown

• 1 other identifier: ASCONO
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

It is planned to conduct a study of nitric oxide metabolites (nitrates and nitrites), L-arginine, arginase-1, and asymmetric dimethylarginine in patients with bronchial asthma and chronic obstructive pulmonary disease, followed by observation to assess the prognosis of the disease.

Conditions

Asthma; COPD

Keywords

nitric oxide, arginine, arginase

Outcome Measures

Primary Outcomes (1)

• Combined outcome - clinical worsening

  Combined outcome including increase in level of basis therapy, exacerbation, hospitalisation and mors associated with Asthma and COPD

  2 years

Secondary Outcomes (4)

• NO-metabolites

  At initial visit

• L-arginine

  At initial visit

• Arginase-1

  At initial visit

• ADMA

  At initial visit

Study Arms (3)

Asthma

Patients with Asthma

COPD

Patients with COPD

Control group

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asthma and COPD patients from Ryazan region which admitted in clinics of the Ryazan State Medical University

You may qualify if:

• men and women aged between 18 and 70 years
• a diagnosis of asthma or chronic obstructive pulmonary disease according to actual GINA and GOLD guidelines

You may not qualify if:

• decompensated pathology of the cardiovascular system;
• history of liver dysfunction accompanied by an increase in ALT, AST or total bilirubin more than 3 times higher than the upper limit of normal;
• history of severe renal impairment, accompanied by a decrease in glomerular filtration rate below 60 ml/min (according to CKD-EPI);
• abuse on psychoactive substances and / or alcohol.

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

Department of Therapy

Ryazan, Ryazanskaya Obl., 390026, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood sample

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Anton Shakhanov, MD, Cand.Sci. (Med.)

  Ryazan State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anton Shakhanov, MD, Cand.Sci. (Med.)

CONTACT

+7 910 635-95-75; shakhanovav@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: September 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)