COPDSUPPORTNCT02248909
Non-interventional Study of Spirometry Use to Diagnose COPD (Chronic Obstructive Pulmonary Disease) and to Prescribe Treatment to COPD Patients in the Outpatient Institutions
An observational study of COPD, run by AstraZeneca at 22 sites in Russia.
Trial summary
This study is an observational multicenter descriptive study. The study will be conducted in primary outpatient medical institutions in different cities of the RF. Primary care doctors who are primary contact for greater part of the population in RF including COPD patients will be invited as investigators. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- How many people
- 4,232 participants
- Where
- 22 sitesRussia
- Study dates
- Nov 2014to May 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with COPD risk factors and patients with previously diagnosed COPD who have been observed in outpatient medical institutions of the RF are planned to be enrolled into the study.
Who may be able to join
None listed.
Who cannot join
- Previously diagnosed chronic obstructive pulmonary disease.
- Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality, cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who had a lung resection in the past due to pulmonary tuberculosis and other lung surgery, patients with stenosis of the upper respiratory tract, post-tracheotomy patients with the developed fibrotic stenosis of the trachea or post-intubation trachea stenosis, patients with ribs fractures of <3 weeks, pneumo- and hydrothorax of any etiology.
- Patients who have contraindications for performing spirometry tests, patients with acute coronary syndrome or unstable circulatory dynamics. Patients who need emergency medical care at the moment of the visit.
- Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.
- Patients with previously diagnosed COPD must meet all the following inclusion criteria:
- Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality, cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who had a lung resection in the past due to pulmonary tuberculosis and other lung surgery, patients with stenosis of the upper respiratory tract, post-tracheotomy patients with fibrotic stenosis of the trachea or post-intubation trachea stenosis, patients with rib fractures of <3 weeks, pneumo- and hydrothorax of any etiology.
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- Active exacerbation of chronic obstructive pulmonary disease at the moment of enrollment into the study.
- Patients who have contraindications for performing spirometry tests, patients with acute coronary syndrome or unstable hemodynamics. Patients who need emergency medical care at the time of the visit.
- Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Russia22 sites
Research Site
Barnaul, Nis-rru-xxx-2014/2
Research Site
Blagoveshchensk, Nis-rru-xxx-2014/2
Research Site
Chelyabinsk, Nis-rru-xxx-2014/2
Research Site
Cherepovets, Nis-rru-xxx-2014/2
Research Site
Izhevsk, Nis-rru-xxx-2014/2
Research Site
Kazan', Nis-rru-xxx-2014/2
Research Site
Kemerovo, Nis-rru-xxx-2014/2
Research Site
Krasnoyarsk, Nis-rru-xxx-2014/2
Research Site
Moscow, Nis-rru-xxx-2014/2
Research Site
Naberezhnye Chelny, Nis-rru-xxx-2014/2
Research Site
Novosibirsk, Nis-rru-xxx-2014/2
Research Site
Omsk, Nis-rru-xxx-2014/2
Research Site
Petrozavodsk, Nis-rru-xxx-2014/2
Research Site
Ryazan, Nis-rru-xxx-2014/2
Research Site
Saint Petersburg, Nis-rru-xxx-2014/2
Research Site
Smolensk, Nis-rru-xxx-2014/2
Research Site
Stavropol, Nis-rru-xxx-2014/3
Research Site
Tomsk, Nis-rru-xxx-2014/2
Research Site
Ulan-Ude, Nis-rru-xxx-2014/2
Research Site
Vladivostok, Nis-rru-xxx-2014/2
Research Site
Yakutsk, Nis-rru-xxx-2014/2
Research Site
Yfa, Nis-rru-xxx-2014/2
About this study
Official title: Non-interventional Multicenter Study of Spirometry Use to Diagnose COPD and to Prescribe Treatment to COPD Patients in the Outpatient Institutions of the healthcaRe System of the Russian FederaTion
This study is an observational multicenter descriptive study. The study will be conducted in primary outpatient medical institutions in different cities of the RF. Primary care doctors who are primary contact for greater part of the population in RF including COPD patients will be invited as investigators. This observational descriptive study will be conducted within the routine practice of outpatient institutions. Since spirometry is not an integral part of the current all-round clinical practice, only those sites where spirometry test is routinely used in examination of patients with COPD risk factors and when monitoring condition of COPD patients will take part in the study. Thus the decision about spirometry in every study subject will be determined only by the existing treatment approaches.
Read the detailed description
The study is an observational multicenter descriptive study. No hypothesis is checked in the study.
3000 patients with COPD risk factors are planned to be enrolled into the study (current smokers and former smokers with smoking history of ≥10 pack/years at the age of >40 years who have respiratory complaints) and 1450 patients previously diagnosed with COPD who contacted the physicians of outpatient institutions during the study (for 3 months) and are currently in remission.
100 patients with COPD risk factors and approximately 50 patients early diagnosed with COPD currently being stable are planned to be enrolled in each site.
Physicians and pulmonologists of the outpatient institutions of the Russian Federation will take part in the study in about 30 sites in 18 cities (a total of 31% of RF population live in the cities).
The observational descriptive study will be conducted within the routine practice of outpatient institutions. Examining and treatment of patients will be performed according to the rules of the routine practice.
Patients will be enrolled into the study as they visit the outpatient institutions for the medical care. The study does not imply any special invitation of COPD patients to the sites for them to be enrolled into the study. Therefore the conditions are made for the study population to reflect the typical visitors of the primary care medical institutions in different RF (Russian Federation) regions. Patients are enrolled into the study regardless the reason for appointment with a doctor. A reason for the appointment can be respiratory complaints as well as any other diseases or certificates and conclusions. To be enrolled into the study the subjects must sign the written Informed Consent Form (ICF) to participate in the study and to use personal data confidentially.
To investigate the role of spirometry in diagnostics and management of the COPD patients, two groups of patients are supposed to be included into the study.
- Conditions
- COPD
- Keywords
- COPD, Primary Care, Spirometry, Risk factors
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD risk factors | Group of subjects with COPD risk factors. This group will include patients aged ≥40 years, with smoking history of ≥10 pack years and long-active (not less than 3 consequent months) respiratory complaints | |
| Patients previously diagnosed with COPD | Group of patients who according to the medical records have already been diagnosed with COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of COPD cases first-time identified by the spirometry in relation to the total number of patients who visited the outpatient institutions of the RF during the study
Measured: Up to 5 months
Percentage of prescriptions for patients with COPD that correspond to the severity of the condition of the patients according to GOLD classification and GOLD recommendations for the treatment choice
Measured: Up to 5 months
Distribution (%) of patients with COPD who contacted the primary care doctors during the study based on bronchial obstruction severity (GOLD 1-4) and classes according to GOLD classification (2014)
Measured: Up to 5 months
Secondary outcomes (6)
The percentage (%) of patients who contact the medical institutions of RF daily can be referred to the group with risk of COPD development
Measured: Up to 5 months
Score on SGRQ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
Measured: Up to 5 months
Score on САТ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
Measured: Up to 5 months
Mean number of puffs of SABA for 24h in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients treated with combined drugs (inhaled corticosteroids and long-acting β2 agonists)
Measured: Upto 5 months
The percentage of COPD patients in the routine practice of these medical institutions
Measured: Up to 5 months
Health-related economic losses calculated on the basis of the collected data (number of hospitalizations due to COPD exacerbations, calls of emergency service due to COPD, seeking outpatient care due to COPD) for the previous year
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Bedenkov, Study director, AstraZenecaVladimir Archipov, Prof., Principal investigator, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248909
- Sponsor's protocol ID
- NIS-RRU-XXX-2014/2
- Acronym
- SUPPORT
- Status last verified
- Jan 2016
- First submitted
- 19 Sep 2014
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Multicenter Study of Spirometry Use to Diagnose COPD and to Prescribe Treatment to COPD Patients in the Outpatient Institutions of the healthcaRe System of the Russian FederaTion
- ClinicalTrials.gov ID
- NCT02248909
- Acronym / sponsor ID
- SUPPORT / NIS-RRU-XXX-2014/2
- Conditions
- COPD
- Keywords
- COPD, Primary Care, Spirometry, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,232 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
This study is an observational multicenter descriptive study. The study will be conducted in primary outpatient medical institutions in different cities of the RF. Primary care doctors who are primary contact for greater part of the population in RF including COPD patients will be invited as investigators. This observational descriptive study will be conducted within the routine practice of outpatient institutions. Since spirometry is not an integral part of the current all-round clinical practice, only those sites where spirometry test is routinely used in examination of patients with COPD risk factors and when monitoring condition of COPD patients will take part in the study. Thus the decision about spirometry in every study subject will be determined only by the existing treatment approaches.
Detailed description
The study is an observational multicenter descriptive study. No hypothesis is checked in the study.
3000 patients with COPD risk factors are planned to be enrolled into the study (current smokers and former smokers with smoking history of ≥10 pack/years at the age of >40 years who have respiratory complaints) and 1450 patients previously diagnosed with COPD who contacted the physicians of outpatient institutions during the study (for 3 months) and are currently in remission.
100 patients with COPD risk factors and approximately 50 patients early diagnosed with COPD currently being stable are planned to be enrolled in each site.
Physicians and pulmonologists of the outpatient institutions of the Russian Federation will take part in the study in about 30 sites in 18 cities (a total of 31% of RF population live in the cities).
The observational descriptive study will be conducted within the routine practice of outpatient institutions. Examining and treatment of patients will be performed according to the rules of the routine practice.
Patients will be enrolled into the study as they visit the outpatient institutions for the medical care. The study does not imply any special invitation of COPD patients to the sites for them to be enrolled into the study. Therefore the conditions are made for the study population to reflect the typical visitors of the primary care medical institutions in different RF (Russian Federation) regions. Patients are enrolled into the study regardless the reason for appointment with a doctor. A reason for the appointment can be respiratory complaints as well as any other diseases or certificates and conclusions. To be enrolled into the study the subjects must sign the written Informed Consent Form (ICF) to participate in the study and to use personal data confidentially.
To investigate the role of spirometry in diagnostics and management of the COPD patients, two groups of patients are supposed to be included into the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD risk factors | – | –Group of subjects with COPD risk factors. This group will include patients aged ≥40 years, with smoking history of ≥10 pack years and long-active (not less than 3 consequent months) respiratory complaints |
| Patients previously diagnosed with COPD | – | –Group of patients who according to the medical records have already been diagnosed with COPD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COPD risk factors and patients with previously diagnosed COPD who have been observed in outpatient medical institutions of the RF are planned to be enrolled into the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Previously diagnosed chronic obstructive pulmonary disease.
- Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality, cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who had a lung resection in the past due to pulmonary tuberculosis and other lung surgery, patients with stenosis of the upper respiratory tract, post-tracheotomy patients with the developed fibrotic stenosis of the trachea or post-intubation trachea stenosis, patients with ribs fractures of <3 weeks, pneumo- and hydrothorax of any etiology.
- Patients who have contraindications for performing spirometry tests, patients with acute coronary syndrome or unstable circulatory dynamics. Patients who need emergency medical care at the moment of the visit.
- Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.
- Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality, cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who had a lung resection in the past due to pulmonary tuberculosis and other lung surgery, patients with stenosis of the upper respiratory tract, post-tracheotomy patients with fibrotic stenosis of the trachea or post-intubation trachea stenosis, patients with rib fractures of <3 weeks, pneumo- and hydrothorax of any etiology.
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
The number of COPD cases first-time identified by the spirometry in relation to the total number of patients who visited the outpatient institutions of the RF during the study
Time frame: Up to 5 months
Percentage of prescriptions for patients with COPD that correspond to the severity of the condition of the patients according to GOLD classification and GOLD recommendations for the treatment choice
Time frame: Up to 5 months
Distribution (%) of patients with COPD who contacted the primary care doctors during the study based on bronchial obstruction severity (GOLD 1-4) and classes according to GOLD classification (2014)
Time frame: Up to 5 months
6 secondary outcomes
The percentage (%) of patients who contact the medical institutions of RF daily can be referred to the group with risk of COPD development
Time frame: Up to 5 months
Score on SGRQ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
Time frame: Up to 5 months
Score on САТ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
Time frame: Up to 5 months
Mean number of puffs of SABA for 24h in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients treated with combined drugs (inhaled corticosteroids and long-acting β2 agonists)
Time frame: Upto 5 months
The percentage of COPD patients in the routine practice of these medical institutions
Time frame: Up to 5 months
Health-related economic losses calculated on the basis of the collected data (number of hospitalizations due to COPD exacerbations, calls of emergency service due to COPD, seeking outpatient care due to COPD) for the previous year
Time frame: Up to 5 months
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 1 Apr 2016.
- CSR SynopsisLink provided by the sponsor.
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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.
Alexander Bedenkov study director
AstraZeneca
Vladimir Archipov, Prof. principal investigator
I.M. Sechenov First Moscow State Medical University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by AstraZeneca at 22 sites 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 0 inclusion and 9 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 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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?
The number of COPD cases first-time identified by the spirometry in relation to the total number of patients who visited the outpatient institutions of the RF during the study (time frame: Up to 5 months). The study lists 3 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 1 Apr 2016.