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

F

Federal State Budgetary Institution, Pulmonology Scientific Research Institute

Status

Unknown

Conditions

Health, Subjective
Hyperreactivity, Bronchial

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04137029
PSRI04-19

Details and patient eligibility

About

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.

Full description

Long-acting beta2-agonists and anticholinergics are main drugs in therapy of chronic obstructive pulmonary disease . Beta-agonists exert their bronchodilatory effects via β2 adrenoceptors located on airway smooth muscle cells. Anticholinergics block mainly M3-cholinoreceptors located in the airways, thus inhibiting bronchoconstriction. Metacholine blocks M2-cholinoreceptors thus inducing bronchoconstriction. It is known, that muscarine and beta-receptors interact with each other, but the detailed mechanism is unknown. For evaluating the binding activity of beta-receptors after inhalation of these drugs the modified radioligand method was used.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

smoking
Experimental group
Description:
Healthy smoking volunteers
Treatment:
Diagnostic Test: metacholine test
Drug: Formoterol
Drug: Tiotropium Bromide
non-smoking
Experimental group
Description:
Healthy non-smoking volunteers
Treatment:
Diagnostic Test: metacholine test
Drug: Formoterol
Drug: Tiotropium Bromide

Trial contacts and locations

1

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Central trial contact

Anna V Eremenko; Kirill A Zykov, Prof

Data sourced from clinicaltrials.gov

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