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Registry of COPD Patients From Outpatient Polyclinic Healthcare Institutions of the Russian Federation in Moscow

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Interregional Public Organization, Russian Respiratory Society
Sponsor:
Information provided by (Responsible Party):
Interregional Public Organization, Russian Respiratory Society
ClinicalTrials.gov Identifier:
NCT02853383
First received: July 14, 2016
Last updated: December 26, 2016
Last verified: December 2016
  Purpose

The purpose of this study is to determine COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow).

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).


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 3 Years
Official Title: Registry of COPD Patients Who Undergo Outpatient Treatment or Are Under Surveillance at Outpatient Polyclinic Healthcare Institutions of the Russian Federation in Moscow

Resource links provided by NLM:


Further study details as provided by Interregional Public Organization, Russian Respiratory Society:

Primary Outcome Measures:
  • COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow). [ Time Frame: 3 years ]
    COPD prevalence among patients registered in the healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of Moscow).

  • To describe the clinical profile of COPD patient in Moscow (including demographic data (age, gender, ethnicity, occupation), smoking status, disease duration, disease severity grade [ Time Frame: 3 years ]
    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).


Secondary Outcome Measures:
  • Characterize percentage (%) of COPD patients who seek attention from primary medical care physicians by severity of airway obstruction according to criteria described in Federal clinical guidelines [ Time Frame: 3 years ]
  • Characterize percentage (%) of COPD patients who seek attention from primary medical care physicians by reversibility of airway obstruction according to criteria described in Federal clinical guidelines [ Time Frame: 3 years ]
  • Monitoring of decrease in lung function (according to spirometry results). [ Time Frame: 3 years ]
  • To determine prevalence of chronic bronchitis phenotype among outpatients [ Time Frame: 3 years ]
  • To determine prevalence of the emphysema phenotype among outpatients [ Time Frame: 3 years ]
  • To determine prevalence of the mixed phenotype among outpatients [ Time Frame: 3 years ]
  • To determine prevalence of the frequent exacerbator phenotype among outpatients [ Time Frame: 3 years ]
  • To determine prevalence of the Asthma+COPD phenotype among outpatients [ Time Frame: 3 years ]
  • To determine the percentage of patients with eosinophilic inflammation according to haematology results [ Time Frame: 3 years ]
  • To describe treatment regimens prescribed to COPD patients depending on disease severity grade in the setting of real-life clinical practice [ Time Frame: 3 years ]
  • To establish the percentage of medical prescriptions for treatment of COPD patients which comply with current Federal clinical guidelines for diagnosis and treatment of chronic obstructive pulmonary disease. [ Time Frame: 3 years ]
  • To establish prevalence of comorbidities in COPD patients. [ Time Frame: 3 years ]
  • To establish pattern of comorbidities in COPD patients. [ Time Frame: 3 years ]
  • To evaluate the disease burden based on the collected data concerning the duration of temporary disability of patients under outpatient surveillance [ Time Frame: 3 years ]
  • To evaluate the disease burden based on the collected data concerning the number of hospitalizations due to COPD exacerbations [ Time Frame: 3 years ]
  • To evaluate the disease burden based on the collected data concerning number of outpatient visits concerning COPD patients under outpatient surveillance [ Time Frame: 3 years ]

Estimated Enrollment: 4050
Study Start Date: December 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Randomly selected polyclinic institutions of Moscow will take part in the study and enrol into the registry 4050 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

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Tuberculosis
  • Sarcoidosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02853383

Contacts
Contact: Olga N Brodskaya, M.D., Ph.D. +79166145695 rropulmo@mail.ru
Contact: Natalia U Kravchenko, M.D. +79161183219 pulmokongress@mail.ru

Locations
Russian Federation
Russian respiratory Society Recruiting
Moscow, Russian Federation, 105077
Contact: Olga N Brodskaya, M.D., Ph.D    +79166145696    rropulmo@mail.ru   
Sponsors and Collaborators
Interregional Public Organization, Russian Respiratory Society
Investigators
Principal Investigator: Andrey S Belevskiy, M.D., Ph.D. Interregional Public Organization "Russian Respiratory Society'
  More Information

Responsible Party: Interregional Public Organization, Russian Respiratory Society
ClinicalTrials.gov Identifier: NCT02853383     History of Changes
Other Study ID Numbers: RRS-001
Study First Received: July 14, 2016
Last Updated: December 26, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Interregional Public Organization, Russian Respiratory Society:
Chronic Obstructive Pulmonary Diseases, COPD

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on March 24, 2017