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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Health, Subjective Hyperreactivity, Bronchial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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smoking

Healthy smoking volunteers

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

The participants will receive inhalation of formoterol 12 micrograms

Tiotropium Bromide

Intervention Type DRUG

The participants will receive inhalation of tiotropium bromide 18 mkg once

metacholine test

Intervention Type DIAGNOSTIC_TEST

The participants will receive inhalation of metacholine once

non-smoking

Healthy non-smoking volunteers

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

The participants will receive inhalation of formoterol 12 micrograms

Tiotropium Bromide

Intervention Type DRUG

The participants will receive inhalation of tiotropium bromide 18 mkg once

metacholine test

Intervention Type DIAGNOSTIC_TEST

The participants will receive inhalation of metacholine once

Interventions

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Formoterol

The participants will receive inhalation of formoterol 12 micrograms

Intervention Type DRUG

Tiotropium Bromide

The participants will receive inhalation of tiotropium bromide 18 mkg once

Intervention Type DRUG

metacholine test

The participants will receive inhalation of metacholine once

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes