CopdNCT04105075
COPD in Obese Patients
An observational study of Copd and Obese, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.
Trial summary
The study included 176 patients with COPD. The first group included 88 normal weight patients with COPD: 71 men and 17 women, mean age 62.40 ± 8.83 years. The second group included 88 patients with COPD and obesity: 64 men and 24 women, mean age 62.94 ± 5.96 years. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Copd, Obese, Obesity, Abdominal
- How many people
- 176 participants
- Where
- 1 siteRussia
- Study dates
- 9 Sep 2018to 20 Sep 2019
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included 176 patients with COPD. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2019) classification, all patients belonged to the group D, GOLD 2-4 (GOLD 1 = forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, GOLD 2 = 50 ≤ FEV1 ≤ 80% predicted, GOLD 3 = 30 ≤ FEV1 ≤ 50% predicted, GOLD 4 = FEV1 < 30% predicted). Patients were divided in two groups depending on the body mass index (BMI): 18.5-24.99 kg / m2 - normal weight, 30 kg / m2 and more - obesity. The first group (group 1) included 88 patients with COPD and normal weight: 71 (80.68%) men and 17 (19.32%) women aged from 43 to 72 years (mean age 62.40 ± 8.83 years). The second group (group 2) - 88 patients with COPD and obesity: 64 (72.73%) men and 24 (27.27%) women aged from 50 to 72 years (mean age 62.94 ± 5.96 years).
Who may be able to join
- COPD diagnosis, informed consent for voluntary participation in the study
Who cannot join
- patient participation in any interventional study,
- COPD exacerbation,
- concomitant lung diseases, such as confirmed or suspected malignant lung disease or other respiratory disease, such as interstitial pulmonary fibrosis, tuberculosis, sarcoidosis, bronchial asthma, bronchiectasis,
- concomitant diseases of other organs and systems, such as acute cardiovascular diseases, chronic kidney diseases and liver failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Features of Chronic Obstructive Pulmonary Disease Clinical Course in Obese Patients
The study included 176 patients with COPD. The first group included 88 normal weight patients with COPD: 71 men and 17 women, mean age 62.40 ± 8.83 years. The second group included 88 patients with COPD and obesity: 64 men and 24 women, mean age 62.94 ± 5.96 years. We assessed the frequency of COPD exacerbations in last 12 months, the severity of symptoms such as dyspnea, sputum production, fatigue. Spirometry, six-minute walk test and analysis of body tissue type composition were performed. BODE index was calculated. Levels of leptin, adiponectin, interleukins-4,6,8,10, interferon-γ, c-reactive protein (CRP), tumor necrosis factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor alpha (TNF-α) were measured in blood serum.
- Conditions
- Copd, Obese, Obesity, Abdominal
- Keywords
- spirometry, inflammation, copd
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity, Obesity, Abdominal, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD and obesity | Patients consented to have a blood sample taken | |
| Normal body weight patients with COPD | Patients consented to have a blood sample taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simptoms
dyspnea, sputum production and fatigue
Measured: 1 year
Labotary tests
Levels of interleukins-4,6,8,10, interferon-γ, tumor necrosis factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor alpha (TNF-α) were measured in blood serum (pg / ml)
Measured: 1 year
Spirometry
FEV1, % pred,FVC, % pred.,FEV1/FVC, %
Measured: 1 year
Labotary tests
Levels of leptin (ng / ml) measured in blood serum
Measured: 1 year
Labotary tests
Levels of adiponectin (µg / ml) measured in blood serum
Measured: 1 year
Secondary outcomes (1)
Symptroms and laboratory correlations
Statistical methods allowing to figure out associations and correlations between blood tests and symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start9 Sep 2018
- Primary completion10 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Voronezh N.N. Burdenko State Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey Budnevsky, Study director, Voronezh State Medical Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105075
- Sponsor's protocol ID
- YSShkatova
- Status last verified
- Sep 2019
- First submitted
- 22 Sep 2019
- Last updated
- 3 Oct 2019
- 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 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Features of Chronic Obstructive Pulmonary Disease Clinical Course in Obese Patients
- ClinicalTrials.gov ID
- NCT04105075
- Acronym / sponsor ID
- YSShkatova
- Conditions
- Copd, Obese, Obesity, Abdominal
- Keywords
- spirometry, inflammation, copd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Voronezh N.N. Burdenko State Medical AcademyUniversity, hospital or other
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 26 Sep 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.
The study included 176 patients with COPD. The first group included 88 normal weight patients with COPD: 71 men and 17 women, mean age 62.40 ± 8.83 years. The second group included 88 patients with COPD and obesity: 64 men and 24 women, mean age 62.94 ± 5.96 years. We assessed the frequency of COPD exacerbations in last 12 months, the severity of symptoms such as dyspnea, sputum production, fatigue. Spirometry, six-minute walk test and analysis of body tissue type composition were performed. BODE index was calculated. Levels of leptin, adiponectin, interleukins-4,6,8,10, interferon-γ, c-reactive protein (CRP), tumor necrosis factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor alpha (TNF-α) were measured in blood serum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD and obesity | – | –Patients consented to have a blood sample taken |
| Normal body weight patients with COPD | – | –Patients consented to have a blood sample taken |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 176 patients with COPD. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2019) classification, all patients belonged to the group D, GOLD 2-4 (GOLD 1 = forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, GOLD 2 = 50 ≤ FEV1 ≤ 80% predicted, GOLD 3 = 30 ≤ FEV1 ≤ 50% predicted, GOLD 4 = FEV1 < 30% predicted). Patients were divided in two groups depending on the body mass index (BMI): 18.5-24.99 kg / m2 - normal weight, 30 kg / m2 and more - obesity. The first group (group 1) included 88 patients with COPD and normal weight: 71 (80.68%) men and 17 (19.32%) women aged from 43 to 72 years (mean age 62.40 ± 8.83 years). The second group (group 2) - 88 patients with COPD and obesity: 64 (72.73%) men and 24 (27.27%) women aged from 50 to 72 years (mean age 62.94 ± 5.96 years).
Key inclusion criteria (1 listed)
- COPD diagnosis, informed consent for voluntary participation in the study
Key exclusion criteria (4 listed)
- patient participation in any interventional study,
- COPD exacerbation,
- concomitant lung diseases, such as confirmed or suspected malignant lung disease or other respiratory disease, such as interstitial pulmonary fibrosis, tuberculosis, sarcoidosis, bronchial asthma, bronchiectasis,
- concomitant diseases of other organs and systems, such as acute cardiovascular diseases, chronic kidney diseases and liver failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Simptoms
Time frame: 1 year
dyspnea, sputum production and fatigue
Labotary tests
Time frame: 1 year
Levels of interleukins-4,6,8,10, interferon-γ, tumor necrosis factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor alpha (TNF-α) were measured in blood serum (pg / ml)
Spirometry
Time frame: 1 year
FEV1, % pred,FVC, % pred.,FEV1/FVC, %
Labotary tests
Time frame: 1 year
Levels of leptin (ng / ml) measured in blood serum
Labotary tests
Time frame: 1 year
Levels of adiponectin (µg / ml) measured in blood serum
1 secondary outcome
Symptroms and laboratory correlations
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 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.
Andrey Budnevsky study director
Voronezh State Medical Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd and Obese, 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 4 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: finished, as of the sponsor's last update on 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simptoms (time frame: 1 year). The study lists 5 primary outcomes in all. 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 3 Oct 2019.