COPD ExacerbationNCT06392334
Mast Cells and Its Proteases in COPD
A study testing Biopsy in people with COPD Exacerbation, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.
Trial summary
Mast cells proteases such as chymase and tryptase will be studied in the tissue of small and large airways in COPD patients Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jan 2019to 30 Sep 2025
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COPD patients
Who cannot join
- Other lung diseases, tumors, pregnancy
- -
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Voronezh State Medical University
Voronezh, 394019
Yanina Shkatova, 9102498731, yankashkat@gmail.com
About this study
Official title: The Role of Mast Cells and Its Proteases in Chronic Obstructive Pulmonary Disease
Mast cells proteases such as chymase and tryptase will be studied in the tissue of small and large airways in COPD patients
- Conditions
- COPD Exacerbation
- Being tested
- Biopsy
- Keywords
- mast cell, tryptase, chymase, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyOther
Biopsy of lung tissue
| Study group | Role | What they receive |
|---|---|---|
| Biopsy | Other | Biopsy of lung tissue will be done Receives: Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mast cells in COPD lung tissue
Assesment of mast cells in lung tissue in COPD patients
Measured: up to 10 -12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start29 Jan 2019
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Voronezh N.N. Burdenko State Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392334
- Sponsor's protocol ID
- Voronezhsma
- Status last verified
- Apr 2024
- First submitted
- 22 Sep 2019
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mast Cells and Its Proteases in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06392334
- Acronym / sponsor ID
- Voronezhsma
- Conditions
- COPD Exacerbation
- Keywords
- mast cell, tryptase, chymase, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Voronezh N.N. Burdenko State Medical AcademyUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
Mast cells proteases such as chymase and tryptase will be studied in the tissue of small and large airways in COPD patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy | Other | Other: BiopsyBiopsy of lung tissue will be done |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients
Key exclusion criteria (2 listed)
- Other lung diseases, tumors, pregnancy
- -
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 |
|---|---|---|
| BiopsyBiopsy of lung tissue | Other | Biopsy |
Primary outcome
Number of mast cells in COPD lung tissue
Time frame: up to 10 -12 months
Assesment of mast cells in lung tissue in COPD patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with COPD Exacerbation, run by Voronezh N.N. Burdenko State Medical Academy 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 2 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 30 Apr 2024. 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 Yanina Shkatova (89611875800, yankashkat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mast cells in COPD lung tissue (time frame: up to 10 -12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.