ClinicalTrials.gg
CompletedNCT02248909SUPPORTUpdated Apr 1, 2016

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 in COPD, sponsored by AstraZeneca. Completed at 22 sites in Russia. Per ClinicalTrials.gov, last updated 2016-04-01.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,232
Sex
All
01

Study 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. 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.

02

Conditions studied

  • COPD

Keywords

  • COPD, Primary Care, Spirometry, Risk factors
03

In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 4,232 is above the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

Patients with COPD risk factors must meet all the following inclusion criteria:

  1. Age ≥ 40 years.
  2. Smoker or former smoker with smoking history of ≥ 10 pack years (patient is considered to be a former smoker in case of smoking cessation for ≥6 months) (the patient smokes or smoked before but then gave up smoking. The obligatory condition: smoking history is ≥10 pack years. It means that the patient smoked a pack per day for 10 years or half a pack for 20 years or 2 packs a day for 5 years).
  3. Any complaints judged by the investigator to be possibly related to the respiratory diseases (chronic cough, dyspnea, cough with sputum, feeling of stiffness in the chest) or the evidence of the chronic respiratory diseases (chronic bronchitis in remission, pneumosclerosis) in the medical chart.
  4. The patient is expected to have the spirometry test performed in accordance with the current medical practice before inviting him to the study.
  5. Patients considered by the investigator to be able to complete themselves questionnaires used in the current study.
  6. Signed Patient's Information Sheet and Informed Consent Form.

Patients with previously diagnosed COPD must meet all the following inclusion criteria:

  1. Male and female of any age who were diagnosed with COPD before the study starts.
  2. Patients whose COPD was not the direct reason for visiting the doctor or COPD patients who have COPD symptoms or signs requiring diagnostic or therapy.
  3. Patients judged by the investigator as being capable to complete themselves the questionnaires used in the current study
  4. Patient was scheduled to have the spirometry test performed in accordance with the existing medical practice before inviting him/her into the study
  5. Signed Patient's Information Sheet and Informed Consent Form.

Exclusion criteria for patients with COPD risk factors:

  1. Previously diagnosed chronic obstructive pulmonary disease.
  2. 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.
  3. 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.
  4. 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:

  1. 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.
  2. Active exacerbation of chronic obstructive pulmonary disease at the moment of enrollment into the study.
  3. 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.
  4. Participation in any interventional clinical trial within 3 months prior the enrollment into the study and at the moment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,232 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. The percentage of COPD patients in the routine practice of these medical institutions

    Time frame: Up to 5 months

  6. 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

07

Study locations

22 sites
  • Research Site
    Barnaul, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Blagoveshchensk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Chelyabinsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Cherepovets, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Izhevsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Kazan', Nis-rru-xxx-2014/2, Russia
  • Research Site
    Kemerovo, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Krasnoyarsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Moscow, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Naberezhnye Chelny, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Novosibirsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Omsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Petrozavodsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Ryazan, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Saint Petersburg, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Smolensk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Tomsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Ulan-Ude, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Vladivostok, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Yakutsk, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Yfa, Nis-rru-xxx-2014/2, Russia
  • Research Site
    Stavropol, Nis-rru-xxx-2014/3, Russia
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2014, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2014
First posted
Sep 25, 2014
Start
Nov 2014
Primary completionActual
May 2015
CompletionActual
May 2015
Last update
Apr 1, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02248909
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Sep 25, 2014
Start date
Nov 2014
Primary completion
May 2015
Completion
May 2015
Last update
Apr 1, 2016

Study contacts

Alexander Bedenkov
study director · AstraZeneca
Vladimir Archipov, Prof.
principal investigator · I.M. Sechenov First Moscow State Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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