Methacholine, Long-acting M-cholinolytic and beta2-agonist on the Activity of Beta-receptors in Healthy Volunteers

NCT04137029 | Unknown DMC

• 1 other identifier: PSRI04-19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional open-labeled study in parallel groups is aimed to evaluate changes of beta receptors in healthy volunteers under the influence of inhaled metacholine, long-acting anticholinergics and beta-agonists using modified radioligand method.

Conditions

Health, Subjective; Hyperreactivity, Bronchial

Keywords

beta-receptors; metacholine; formoterol; tiotropium

Outcome Measures

Primary Outcomes (2)

• Change from baseline beta-receptor binding activity at 60 min after the inhalation of formoterol or tiotropium.

  Beta-receptor binding activity will be measured with modified radioligand method before and after 60 min after the inhalation of formoterol or tiotropium

  Baseline (pre-dose), 60 minutes

• Change from baseline beta-receptor binding activity at 40 min after the challenge test with metacholine.

  Beta-receptor binding activity will be measured with modified radioligand method before and after 40 min after the challenge test with metacholine.

  Baseline (pre-dose), 40 minutes

Secondary Outcomes (4)

• Comparison of beta-receptor binding activity measured with modified radioligand after formoterol and tiotropium.

  Baseline (pre-dose), 60 minutes

• Comparison of beta-receptor binding activity measured with modified radioligand method after formoterol or tiotropium in smokers and non-smokers.

  Baseline (pre-dose), 60 minutes

• Comparison of beta-receptor binding activity measured with modified radioligand after metacholine

  Baseline (pre-dose), 40 minutes

• Comparison of beta-receptor binding activity measured with modified radioligand method after inhalation of metacholine in smokers and non-smokers.

  Baseline (pre-dose), 40 minutes

Study Arms (2)

smoking

EXPERIMENTAL

Healthy smoking volunteers

Drug: Formoterol; Drug: Tiotropium Bromide; Diagnostic Test: metacholine test

non-smoking

EXPERIMENTAL

Healthy non-smoking volunteers

Drug: Formoterol; Drug: Tiotropium Bromide; Diagnostic Test: metacholine test

Interventions

Formoterol DRUG

The participants will receive inhalation of formoterol 12 micrograms

non-smoking; smoking

Tiotropium Bromide DRUG

The participants will receive inhalation of tiotropium bromide 18 mkg once

non-smoking; smoking

metacholine test DIAGNOSTIC_TEST

The participants will receive inhalation of metacholine once

non-smoking; smoking

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form 2. Healthy male or female, aged 18-60 years

You may not qualify if:

• Participants unable to perform spirometry
• Exacerbation respiratory infection within the previous four weeks
• Hypersensitivity or allergy to formoterol, metacholine or tiotropium bromide
• Females who are currently pregnant and lactating
• major surgery in the last 6 months
• Refusal to participate
• Currently participating in another clinical study

Sponsors & Collaborators

• Federal State Budgetary Institution, Pulmonology Scientific Research Institute: lead
• Moscow State University of Medicine and Dentistry: collaborator
• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: collaborator
• Branch of Shemyakin-Ovchinnikov Institute of Bioorganic chemistry of RAS: collaborator

Study Sites (1)

Kirill Zykov

Moscow, 115682, Russia

RECRUITING

Related Publications (3)

• Agapova OY, Skoblov YS, Zykov KA, Rvacheva AV, Beilina VB, Masenko VP, Chazova IE. [Radioligand Method of Assessment of beta-Adrenoceptor's Activity on Human T-Lymphocytes]. Bioorg Khim. 2015 Sep-Oct;41(5):592-8. doi: 10.1134/s1068162015050027. Russian.

  PMID: 26762097 RESULT

• Agapova OY, Skoblov YS, Tkachev GA, Mironova NA, Golitsyn SP, Masenko VP, Chazova IE, Zykov KA. [Changes in the receptor activity of beta2-adrenoreceptors of human T-lymphocytes under the effect of beta2-agonists]. Mol Biol (Mosk). 2016 Nov-Dec;50(6):999-1006. doi: 10.7868/S0026898416050025. Russian.

  PMID: 28064316 RESULT

• Smolyakova E.V., Skoblov Y.S., Skoblova N.A., Agapova O.Y., Ambat'ello L.G., Klimova A.A., Kuznetsova T.V., Masenko V.P., Nistor S.Yu., Rvacheva A.V., Chazova I.E., Zykov K.A. Specificity and Selectivity of the Modified Radioligand Method for Assessment of β1-Adrenoreceptor's Binding Activity on Human T-Lymphocytes. Russian Journal of Bioorganic Chemistry 45(3): 295-301, 2019

  RESULT

MeSH Terms

Conditions

Bronchial Hyperreactivity

Interventions

Formoterol Fumarate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Kirill A Zykov, Prof

  Federal State Budgetary Institution, Pulmonology Scientific Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirill A Zykov, Prof

CONTACT

+79257729462; kirillaz@inbox.ru

Anna V Eremenko

CONTACT

+79265598031; a_nn87@list.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: There are two groups: the first group is smokers, the second group is non - smokers. The participants of both groups will receive metacholine on the first visit, formoterol 12 micrograms on the second visit, then tiotropium bromide 18 mkg on the third visit.

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 23, 2019
• Study Start: April 24, 2019
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)