NCT02853383

Brief Summary

To describe the clinical profile of COPD patient who is under outpatient surveillance at polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity, occupation), smoking status, disease duration, disease severity grade, distribution by disease phenotype, disease exacerbation rate in the setting of real-life clinical practice).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

July 14, 2016

Last Update Submit

February 1, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Diseases, COPD

Outcome Measures

Primary Outcomes (2)

  • COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow).

    COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow).

    1 day

  • To describe the clinical profile of COPD patient in Moscow (including demographic data (age, gender, ethnicity, occupation), smoking status, disease duration, disease severity grade

    To describe the clinical profile of COPD patient who is under outpatient surveillance at polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity, occupation), smoking status, disease duration, disease severity grade, distribution by disease phenotype, disease exacerbation rate in the setting of real-life clinical practice).

    1 day

Secondary Outcomes (12)

  • Percentage of patients with different disease phenotypes among outpatients

    1 day

  • Percentage of prescriptions of medicinal products to COPD patients depending on disease severity grade in the setting of real-life clinical practice

    1 year

  • Distribution (%) of COPD patients who seek attention from primary medical care physicians by severity of airway obstruction

    1 year

  • Mean number of exacerbations requiring medical attention (outpatient prescription of oral corticosteroids and/or antibiotics) in the last year in COPD patients

    1 year

  • Mean number of hospitalizations in the last year in COPD patients

    1 year

  • +7 more secondary outcomes

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Randomly selected polyclinic institutions of Moscow will take part in the study and enrol into the registry 2000 patients for representativeness of sample for analysis of COPD prevalence in Moscow. The patient population includes male and female patients over 40 years of age, smokers or ex-smokers, under outpatient surveillance at polyclinic institutions of Moscow with diagnosis codes according to ICD J40 - J44 and diagnosed COPD, as confirmed by spirometry results

You may qualify if:

  • smokers or ex-smokers, with previously diagnosed COPD
  • COPD diagnosis corresponding to ICD codes J40 - J44 (J40 - Bronchitis, not specified as acute or chronic, J41 - Simple and mucopurulent chronic bronchitis, J41.0 - Simple chronic bronchitis, J41.8 - Mixed simple and mucopurulent chronic bronchitis, J 42 - Unspecified chronic bronchitis, J 43 - Emphysema, J 44 - Other chronic obstructive pulmonary disease
  • COPD diagnosis confirmed by spirometry results (spirometry is performed as normal with bronchodilator testing using salbutamol 400 µg, post-BD FEV1\\ FVC \< 0.7)

You may not qualify if:

  • Tuberculosis
  • Sarcoidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Russian respiratory Society

Moscow, 105077, Russia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrey S Belevskiy, M.D., Ph.D.

    Interregional Public Organization "Russian Respiratory Society'

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga N Brodskaya, M.D., Ph.D.

CONTACT

+79166145695rropulmo@mail.ru

Natalia U Kravchenko, M.D.

CONTACT

+79161183219pulmokongress@mail.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

August 2, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)