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

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)

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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