Health, SubjectiveNCT04137029
Methacholine, Long-acting M-cholinolytic and beta2-agonist on the Activity of Beta-receptors in Healthy Volunteers
A study testing Formoterol, Tiotropium Bromide and metacholine test in people with Health, Subjective and Hyperreactivity, Bronchial, run by Federal State Budgetary Institution, Pulmonology Scientific Research Institute at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective, Hyperreactivity, Bronchial
- What is being tested?
- Formoterol, Tiotropium Bromide and metacholine test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 24 Apr 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1 Provision of signed and dated informed consent form 2. Healthy male or female, aged 18-60 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Kirill Zykov
Moscow, 115682
Kirill Zykov, Prof, +74953956393, pulmo_fmba@mail.ru
Anna Eremenko, +79265598031, a_nn87@list.ru
About this study
Official title: Effect of Methacholine, Long-acting M-cholinolytic and beta2-agonist on the Binding Activity of Beta-receptors in Healthy Volunteers
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.
Read the detailed 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.
- Conditions
- Health, Subjective, Hyperreactivity, Bronchial
- Being tested
- Formoterol, Tiotropium Bromide, metacholine test
- Keywords
- beta-receptors, metacholine, formoterol, tiotropium
- Medical subject headings
- Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormoterolDrug
The participants will receive inhalation of formoterol 12 micrograms
Tiotropium BromideDrug
The participants will receive inhalation of tiotropium bromide 18 mkg once
metacholine testDiagnostic test
The participants will receive inhalation of metacholine once
| Study group | Role | What they receive |
|---|---|---|
| smoking | Experimental | Healthy smoking volunteers Receives: Drug: Formoterol; Drug: Tiotropium Bromide; Diagnostic Test: metacholine test |
| non-smoking | Experimental | Healthy non-smoking volunteers Receives: Drug: Formoterol; Drug: Tiotropium Bromide; Diagnostic Test: metacholine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline (pre-dose), 40 minutes
Secondary outcomes (4)
Comparison of beta-receptor binding activity measured with modified radioligand after formoterol and tiotropium.
Difference of change of beta-receptor binding activity measured with modified radioligand method before and after 60 min after the inhalation of formoterol and tiotropium.
Measured: 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.
Difference of change of beta-receptor binding activity measured with modified radioligand method before and after 60 min after the inhalation of formoterol or tiotropium in smokers and non-smokers.
Measured: Baseline (pre-dose), 60 minutes
Comparison of beta-receptor binding activity measured with modified radioligand after metacholine
Difference of change of beta-receptor binding activity measured with modified radioligand method before and after inhalation of metacholine
Measured: 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.
Difference of change of beta-receptor binding activity measured with modified radioligand method before and after inhalation of metacholine
Measured: Baseline (pre-dose), 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start24 Apr 2019
- Primary completionJul 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, Pulmonology Scientific Research Institute
- Sponsor type
- Other government
- Collaborators
- Moscow State University of Medicine and Dentistry, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, Branch of Shemyakin-Ovchinnikov Institute of Bioorganic chemistry of RAS
- Responsible party
- Sponsor
- Investigators
- Kirill A Zykov, Prof, Principal investigator, Federal State Budgetary Institution, Pulmonology Scientific Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137029
- Sponsor's protocol ID
- PSRI04-19
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26762097Agapova 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.
PubMed 28064316Smolyakova 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Methacholine, Long-acting M-cholinolytic and beta2-agonist on the Binding Activity of Beta-receptors in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04137029
- Acronym / sponsor ID
- PSRI04-19
- Conditions
- Health, Subjective, Hyperreactivity, Bronchial
- Keywords
- beta-receptors, metacholine, formoterol, tiotropium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, Pulmonology Scientific Research InstituteOther government
- Collaborators
- Moscow State University of Medicine and Dentistry, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, Branch of Shemyakin-Ovchinnikov Institute of Bioorganic chemistry of RAS
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| smoking | Experimental | Drug: Formoterol, Drug: Tiotropium Bromide, Diagnostic Test: metacholine testHealthy smoking volunteers |
| non-smoking | Experimental | Drug: Formoterol, Drug: Tiotropium Bromide, Diagnostic Test: metacholine testHealthy non-smoking volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1 Provision of signed and dated informed consent form 2. Healthy male or female, aged 18-60 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FormoterolThe participants will receive inhalation of formoterol 12 micrograms | Drug | non-smoking, smoking |
| Tiotropium BromideThe participants will receive inhalation of tiotropium bromide 18 mkg once | Drug | non-smoking, smoking |
| metacholine testThe participants will receive inhalation of metacholine once | Diagnostic test | non-smoking, smoking |
Primary outcome
Change from baseline beta-receptor binding activity at 60 min after the inhalation of formoterol or tiotropium.
Time frame: Baseline (pre-dose), 60 minutes
Beta-receptor binding activity will be measured with modified radioligand method before and after 60 min after the inhalation of formoterol or tiotropium
Change from baseline beta-receptor binding activity at 40 min after the challenge test with metacholine.
Time frame: Baseline (pre-dose), 40 minutes
Beta-receptor binding activity will be measured with modified radioligand method before and after 40 min after the challenge test with metacholine.
4 secondary outcomes
Comparison of beta-receptor binding activity measured with modified radioligand after formoterol and tiotropium.
Time frame: 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.
Time frame: Baseline (pre-dose), 60 minutes
Comparison of beta-receptor binding activity measured with modified radioligand after metacholine
Time frame: 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.
Time frame: Baseline (pre-dose), 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Results publication: PubMed 26762097Agapova 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.
- Results publication: PubMed 28064316Agapova 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.
- Results publicationSmolyakova 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirill A Zykov, Prof principal investigator
Federal State Budgetary Institution, Pulmonology Scientific Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formoterol, Tiotropium Bromide and metacholine test in people with Health, Subjective and Hyperreactivity, Bronchial, run by Federal State Budgetary Institution, Pulmonology Scientific Research Institute at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirill A Zykov, Prof (+79257729462, kirillaz@inbox.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline beta-receptor binding activity at 60 min after the inhalation of formoterol or tiotropium. (time frame: Baseline (pre-dose), 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137029, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.